Yusuf Yazici, M.D.

Efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis and a previous inadequate response to disease-modifying antirheumatic drugs: the ROSE study
Yazici, Yusuf; Curtis, Jeffrey R; Ince, Akgun; Baraf, Herbert; Malamet, Raymond L; Teng, Lichen L; Kavanaugh, Arthur
2012 Feb;71(2):198-205, Annals of rheumatic diseases
OBJECTIVE: To evaluate efficacy of tocilizumab in US patients with moderate to severe active rheumatoid arthritis (RA) and inadequate clinical response to disease-modifying antirheumatic drugs (DMARD). Safety-related outcomes were also analysed. METHODS: The rapid onset and systemic efficacy study was a 24-week, randomised, double-blind trial. Patients were randomly assigned 2:1 to tocilizumab 8 mg/kg (n=412) or placebo (n=207) every 4 weeks while continuing background DMARD in both groups. RESULTS: The primary efficacy endpoint, percentage of patients achieving ACR50 response at week 24, was higher with tocilizumab versus placebo (30.1% vs 11.2%; p<0.0001). Percentages of ACR20 and ACR50 responders were significantly higher with tocilizumab versus placebo as early as week 4 and continued to week 24; more patients in the tocilizumab versus placebo group also achieved ACR70 responses beginning at week 8 (p<0.01). Significant improvements associated with tocilizumab versus placebo were seen in routine assessment of patient index data responses, EULAR good response, DAS28 and percentages of patients achieving low disease activity and clinical remission (based on DAS28). A substudy examining early response to therapy showed improved patient global assessment of disease activity (p=0.005) and pain (p=0.01) and DAS28 (p=0.007) with tocilizumab versus placebo at day 7. Safety findings were consistent with the known tocilizumab safety profile; rates of serious infections (per 100 patient-years) were 7.87 (95% CI 4.30 to 13.2) and 1.20 (95% CI 0.03 to 6.66) in the tocilizumab and placebo groups, respectively. CONCLUSIONS: This study demonstrated the efficacy of tocilizumab in improving measures of disease activity in patients with RA who failed to respond adequately to DMARD therapy. Rapid improvement in clinical outcomes was demonstrated in a substudy as early as week 1 as shown by DAS28 scores, patient measures and C-reactive protein. Trial Registry no NCT00531817
— id: 148726, year: 2012, vol: 71, page: 198, stat: Journal Article,

Assesment of Disease Activity in Ankylosing Spondylitis: Comparison of Rapid3, Basdai, Basfi, and Asdas Scores in Routine Care
Cinar, Muhammet; Yilmaz, Sedat; Koca, Suleyman Serdar; Erdem, Hakan; Pay, Salih; Yazici, Yusuf; Simsek, Ismail
2011 OCT ;63(10 S S):S735-S735, Arthritis & rheumatism
— id: 147017, year: 2011, vol: 63, page: S735, stat: Journal Article,

An Audit of Behcet's Syndrome Research: A 10-year Survey
Esen, Fehim; Schimmel, Elizabeth K; Yazici, Hasan; Yazici, Yusuf
2011 Jan;38(1):99-103, Journal of rheumatology
OBJECTIVE: Data suggest that the use of disease control groups and proper use of power calculations were neglected in published reports. We surveyed these and other methodological shortcomings in reports published within the last decade about one specific topic, Behcet's syndrome. We reason that recognizing such methodological shortcomings will lead to better quality clinical and basic science articles. METHODS: Articles published in the 15 highest impact factor journals on rheumatology, ophthalmology, dermatology, and general medicine between January 1999 and January 2009 were searched for original reports on Behcet's syndrome. Study designs (study types and time element), control groups, demographic data, use of power calculations, and reporting of negative results were specifically tabulated. RESULTS: Most studies on Behcet's syndrome were cross-sectional (83%). Prospective longitudinal studies were few (7%). In a considerable proportion of papers (21%), some basic demographic data were missing. Power calculations were rare (3%) even in randomized controlled trials and were not considered at all in clinical hypothesis-testing. Disease control groups were present in slightly over half of clinical and laboratory original research, while just 13% of genetic association studies included disease controls. Only 12% of all reports concerned mainly negative outcomes. CONCLUSION: A considerable number of the published research articles have methodological weaknesses. The generalizability of what we observed in Behcet's syndrome to other research topics needs to be formally studied
— id: 117337, year: 2011, vol: 38, page: 99, stat: Journal Article,

Current management of Behcet's syndrome
Nowatzky J.; Yazici Y.
2011 ;72(7):647-656, Drug development research
Behcet's syndrome (BS), or Behcet's disease (BD), is a multisystem inflammatory disorder that mainly affects population clusters along the Old Silk Road; however, it has been reported worldwide. The disease is currently classified as a vasculitis, characterized by sporadic outbreaks. The hallmarks of BS are recurrent, painful oral ulcers. Skin, eyes, central nervous system (CNS), gastrointestinal tract (GI) tract, and other organs may also be involved. CNS, GI, and major vascular involvement can be life-threatening, and uveitis may lead to blindness. Immunosuppressive and immunomodulatory treatment is the mainstay of therapy for this inflammatory disease. Whereas the most frequently used agents for the treatment of BS have been corticosteroids, colchicine, and azathioprine, the introduction of anti-tumor necrosis factor (TNF) agents and interferon-alpha (IFN-alpha) has begun to revolutionize the treatment of Behcet's eye disease and the management of other major organ manifestations. Data from randomized controlled trials (RCTs) showing beneficial effects for some of its disease manifestations are available for azathioprine, colchicine, cyclosporine, etanercept, IFN-alpha depot-methylprednisolone, and others. Currently, an evidence-based approach to the management of BS is possible only for eye, mucocutaneous, and joint involvement, whereas recommendations for the treatment of gastrointestinal, neurological, and vascular disease remain based on expert opinion. 2011 Wiley Periodicals, Inc
— id: 145742, year: 2011, vol: 72, page: 647, stat: Journal Article,

RAPID3 (Routine Assessment of Patient Index Data 3) severity categories and response criteria: Similar results to DAS28 (Disease Activity Score) and CDAI (Clinical Disease Activity Index) in the RAPID 1 (Rheumatoid Arthritis Prevention of Structural Damage) clinical trial of certolizumab pegol
Pincus T.; Furer V.; Keystone E.; Yazici Y.; Bergman M.J.; Luijtens K.
2011 ;63(8):1142-1149, Arthritis & rheumatism
Objective: To compare categories for activity/severity according to the Disease Activity Score 28-joint count (DAS28), the Clinical Disease Activity Index (CDAI), and the Routine Assessment of Patient Index Data 3 (RAPID3), an index without formal joint counts calculated in 5 versus >100 seconds, as well as the European League Against Rheumatism (EULAR)-DAS28 and the RAPID3 response criteria, in the Rheumatoid Arthritis Prevention of Structural Damage (RAPID 1) clinical trial of certolizumab pegol (CZP). Methods: Post hoc analyses were performed using correlations, cross-tabulations, and kappa statistics. Patients (treated with CZP plus methotrexate [MTX] or placebo plus MTX) were classified at baseline and at 52 weeks as high, moderate, low activity/severity or remission, according to the DAS28 (>5.1, >3.2 to <=5.1, 2.6 to <=3.2, <2.6 [total range 0-10]), the CDAI (>22, >10 to <=22, >2.8 to <=10, <=2.8 [total range 0-76]), and RAPID3 (>12, >6 to <=12, >3 to <=6, <=3 [total range 0-30]), as well as for good, moderate, and poor EULAR-DAS28 and proposed RAPID3 response criteria. Results: All measures were correlated significantly: RAPID3 with DAS28 and CDAI (rho > 0.7), higher than erythrocyte sedimentation rate with C-reactive protein level (rho = 0.47). At 52 weeks, DAS28, CDAI, and RAPID3 low activity/remission was seen in 30%, 44%, and 42% of CZP-treated patients versus 3%, 7%, and 10% of control patients. Good, moderate, and poor EULAR-DAS28 responses were seen in 30%, 51%, and 19% of CZP-treated patients versus 3%, 28%, and 70% of control patients, and for RAPID3 in 39%, 30%, and 32% of CZP-treated patients versus 8%, 16%, and 76% of control patients. Kappa and weighted kappa values ranged from 0.36-0.53, indicating fair to moderate agreement. Conclusion: RAPID3, DAS28, and CDAI give similar results to distinguish CZP patients from controls in the RAPID 1 clinical trial. DAS28 is specific for clinical trials; RAPID3 appears pragmatically useful for usual care. 2011, American College of Rheumatology
— id: 137009, year: 2011, vol: 63, page: 1142, stat: Journal Article,

RAPID3 (Routine Assessment of Patient Index Data 3) severity categories and response criteria: Similar results to DAS28 (Disease Activity Score) and CDAI (Clinical Disease Activity Index) in the RAPID 1 (Rheumatoid Arthritis Prevention of Structural Damage) clinical trial of certolizumab pegol
Pincus, Theodore; Furer, Victoria; Keystone, Edward; Yazici, Yusuf; Bergman, Martin J; Luijtens, Kristel
2011 Aug;63(8):1142-1149, Arthritis care & research
OBJECTIVE: To compare categories for activity/severity according to the Disease Activity Score 28-joint count (DAS28), the Clinical Disease Activity Index (CDAI), and the Routine Assessment of Patient Index Data 3 (RAPID3), an index without formal joint counts calculated in 5 versus >100 seconds, as well as the European League Against Rheumatism (EULAR)- DAS28 and the RAPID3 response criteria, in the Rheumatoid Arthritis Prevention of Structural Damage (RAPID 1) clinical trial of certolizumab pegol (CZP). METHODS: Post hoc analyses were performed using correlations, cross-tabulations, and kappa statistics. Patients (treated with CZP plus methotrexate [MTX] or placebo plus MTX) were classified at baseline and at 52 weeks as high, moderate, low activity/severity or remission, according to the DAS28 (>5.1, >3.2 to </=5.1, 2.6 to </=3.2, <2.6 [total range 0-10]), the CDAI (>22, >10 to </=22, >2.8 to </=10, </=2.8 [total range 0-76]), and RAPID3 (>12, >6 to </=12, >3 to </=6, </=3 [total range 0-30]), as well as for good, moderate, and poor EULAR-DAS28 and proposed RAPID3 response criteria. RESULTS: All measures were correlated significantly: RAPID3 with DAS28 and CDAI (rho > 0.7), higher than erythrocyte sedimentation rate with C-reactive protein level (rho = 0.47). At 52 weeks, DAS28, CDAI, and RAPID3 low activity/remission was seen in 30%, 44%, and 42% of CZP-treated patients versus 3%, 7%, and 10% of control patients. Good, moderate, and poor EULAR-DAS28 responses were seen in 30%, 51%, and 19% of CZP-treated patients versus 3%, 28%, and 70% of control patients, and for RAPID3 in 39%, 30%, and 32% of CZP-treated patients versus 8%, 16%, and 76% of control patients. Kappa and weighted kappa values ranged from 0.36-0.53, indicating fair to moderate agreement. CONCLUSION: RAPID3, DAS28, and CDAI give similar results to distinguish CZP patients from controls in the RAPID 1 clinical trial. DAS28 is specific for clinical trials; RAPID3 appears pragmatically useful for usual care
— id: 135554, year: 2011, vol: 63, page: 1142, stat: Journal Article,

Proposed Severity and Response Criteria for Routine Assessment of Patient Index Data (RAPID3): Results for Categories of Disease Activity and Response Criteria in Abatacept Clinical Trials
Pincus, Theodore; Hines, Patricia; Bergman, Martin J; Yazici, Yusuf; Rosenblatt, Lisa C; Maclean, Ross
2011 Dec;38(12):2565-2571, Journal of rheumatology
Background. An index is needed to assess the status of patients with rheumatoid arthritis (RA), as none of the existing measures are applicable to all individual patients. The 28-joint Disease Activity Score (DAS28) is the most specific and widely used index. Routine Assessment of Patient Index Data (RAPID3) is an index containing only the 3 patient self-report core dataset measures, without a laboratory test or formal joint count, and with simple scoring. RAPID3 is correlated significantly with DAS28, but calculated in 5-10 seconds on a Multidimensional Health Assessment Questionnaire (MDHAQ), compared to 114 seconds for DAS28. METHODS: DAS28 (0-10 scale) categories for high, moderate, and low activity, and remission (</= 2.6, 2.6-3.2, 3.21-5.1, and > 5.1, respectively) and proposed RAPID3 (0-30 scale) categories for severity (0 </= 3, 3.1-6, 6.1-12, and > 12) were compared in patients taking abatacept and control-treated patients at the endpoint of the Abatacept in Inadequate Response to Methotrexate (AIM) and the Abatacept Trial in Treatment of Anti-TNF INadequate Responders (ATTAIN) clinical trials, using cross-tabulations and kappa statistics. RESULTS: Overall, 92%-99% of patients classified as having high DAS28 activity had high or moderate RAPID3 severity, while 64%-83% in DAS28 remission had RAPID3 low severity or remission; 50%-82% of patients with good or poor EULAR responses had good or poor RAPID3 responses. Kappa values ranged from 0.25 to 0.48, and weighted kappas from 0.32 to 0.52, indicating fair to moderate agreement for the 2 indices. CONCLUSION: Proposed RAPID3 severity and response categories yield comparable results to DAS28 and EULAR criteria in AIM and ATTAIN. DAS28 is more specific for clinical trials. RAPID3 does not preclude also scoring DAS28, and may be informative in the infrastructure of routine care
— id: 145768, year: 2011, vol: 38, page: 2565, stat: Journal Article,

Association of ACR Clinical Responses with CDAI (Clinical Disease Activity Index) and RAPID3 (Routine Assessment of Patient Index Data 3) Indices of Disease Activity in Rheumatoid Arthritis Patients Treated with Certolizumab Pegol Plus Methotrexate
Schiff, Michael H.; Luijtens, Kristel; Davies, Owen; Yazici, Yusuf
2011 OCT ;63(10 S S):S490-S490, Arthritis & rheumatism
— id: 147018, year: 2011, vol: 63, page: S490, stat: Journal Article,

A Possible Source of Error in the Method of Cancer Risk Estimation in Patients with Rheumatoid Arthritis
Yazici, Hasan; Tascilar, Koray; Yazici, Yusuf; Kiroglu, Gulay; Duransoy, Levent; Erar, Aydin
2011 OCT ;63(10 S S):S40-S41, Arthritis & rheumatism
— id: 147019, year: 2011, vol: 63, page: S40, stat: Journal Article,

Rheumatoid arthritis: When should we use rituximab to treat RA?
Yazici, Yusuf
2011 ;7(7):379-380, Nature reviews. Rheumatology
— id: 134913, year: 2011, vol: 7, page: 379, stat: Journal Article,

THE ROSE STUDY: EFFICACY AND SAFETY OF TOCILIZUMAB IN RA PATIENTS WITH PREVIOUS INADEQUATE RESPONSE TO DMARDS
Yazici, Yusuf; Curtis, Jeffrey; Ince, Akgun; Baraf, Herbert; Malamet, Raymond; Chung, Carol Y.; Kavanaugh, Arthur
2011 APR ;50(6027):127-127, Rheumatology (Oxford)
— id: 131831, year: 2011, vol: 50, page: 127, stat: Journal Article,

Greater remission rates in patients with early versus long-standing disease in biologic-naive rheumatoid arthritis patients treated with abatacept: a post hoc analysis of randomized clinical trial data
Yazici, Yusuf; Moniz Reed, Diane; Klem, Christian; Rosenblatt, Lisa; Wu, G; Kremer, Joel M
2011 May-Jun;29(3):494-499, Clinical & experimental rheumatology
OBJECTIVES: Current aim of rheumatoid arthritis (RA) reatment is to achieve remission in as many patients as possible. Rates of remission and clinical outcomes after treatment with abatacept in biologic-naive rheumatoid arthritis (RA) patients with early disease and an inadequate response to methotrexate (MTX) versus patients with >/=10 years of disease were assessed. METHODS: Data from two trials assessing the efficacy of abatacept in MTX inadequate responders were pooled for this exploratory post hoc analysis. Patients with disease duration of </=2 years at baseline (early disease), originally assigned to an abatacept approximately 10 mg/kg treatment arm and entered into a long-term extension (LTE), were compared with patients with >/=10 years of disease (long-standing RA). Remission, DAS28-CRP, ACR 70 responses and the Routine Assessment of Patient Index Data 3 (RAPID3), improvement in physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). RESULTS: Twenty-three percent of these patients (n=108) had early disease. A higher percentage of patients with early disease achieved DAS28-CRP remission versus patients with long-standing disease (35.2% vs. 19.4% at year 1, p<0.01; 46.0% vs. 30.9% at year 3, p<0.05). In addition, a higher percentage of the subgroup with early RA achieved ACR70 responses. More patients with early RA had a meaningful improvement in their HAQ-DI (75.2% vs. 60.4%; p<0.05) and RAPID3 scores at one year (mean changes from baseline of -9.6 vs. -8.1; p=0.009). CONCLUSIONS: These data provide additional support for the possible use of abatacept in biologic-naive patients who have had inadequate response to MTX, earlier in their disease course
— id: 134925, year: 2011, vol: 29, page: 494, stat: Journal Article,

Promising new treatments for rheumatoid arthritis - the kinase inhibitors
Yazici, Yusuf; Regens, Alexandra L
2011 ;69(3):233-237, Bulletin of the NYU Hospital for Joint Diseases
Three major advances over the last decade have impacted the way we treat rheumatoid arthritis; early and aggressive treatment, use of disease activity measures leading to treat to target, and availability of biologic agents. No oral biologic agents are available at this time but promising data is emerging for two drugs, tofacitinib and fostamatinib, inhibitors of JAK and Syk kinases, respectively. This paper will review some of the relevant published data for these agents and discuss where they may be placed in our treatment options for RA
— id: 145761, year: 2011, vol: 69, page: 233, stat: Journal Article,

Clinical Response At Months 1-6 Can Predict Likelihood of Achieving Remission in Abatacept Plus Methotrexate-Treated Patients with Early Rheumatoid Arthritis
Yazici, Yusuf; Wollenhaupt, Jurgen; Durez, Patrick; Gomez-Reino, Juan J.; Grassi, Walter; Le Bars, Manuela; Gaillez, Corine; Poncet, Coralie; Elegbe, Ayanbola; Westhovens, Rene
2011 OCT ;63(10 S S):S484-S484, Arthritis & rheumatism
— id: 147020, year: 2011, vol: 63, page: S484, stat: Journal Article,

Discordance between self-report and physician-assessed disease activity in patients with systemic lupus erythematosus (SLE): Implications for clinical trial design and clinical care
Askanase A.D.; Castrejon I.; Buyon J.P.; Yazici Y.; Pincus T.
2010 ;62:1857-1857, Arthritis & rheumatism
Purpose: To analyze agreement levels between patient (PT) and physician (MD) assessments in 50 patients with SLE seen in usual care, including a) global PT and MD estimates of status; b) patient self-report scores on the SLAQ (Systemic Lupus Activity Questionnaire) and MDHAQ (Multidimensional Health Assessment Questionnaire) for physical function (FN), pain (PN), patient global estimate (PTGL), fatigue (FT), RAPID3 (FN, PN, and PTGL), and review of systems checklist (SX); c) physician-scored indices SLEDAI-2K (SLE Disease Activity Index), BILAG (British Isles Lupus Assessment Group index), SLAM (SLE Activity Measure) and ECLAM (European Consensus Lupus Activity Measurement). Methods: A cross-sectional study was performed in 50 consecutive SLE patients of one rheumatologist. Patients completed the SLAQ and MDHAQ, including PTGL. The rheumatologist scored a physician global estimate (MDGL) (scored 0-3 in 0.1 increments) without knowledge of PTGL, and completed the SLEDAI 2K, BILAG, SLAM, and ECLAM. Agreement levels of various measures were analyzed using Spearman rank order correlations. Results: The study included 45 women and 5 men, mean age 38.7 years, mean disease duration 7.3 years, 36% Caucasian, 18% Black, 26% Hispanic, 18% Asian. The mean MDGL (1.10+/-0.62), PTGL (3.11 +/-2.81) and SLE indices (SLEDAI 5.02+/-3.75; BILAG 4.60+/-4.31; SLAM 3.86+/-2.92; ECLAM 1.97+/-1.37) indicated mild/moderate lupus activity. The correlation between MDGL and PTGL of rho=0.14 was not statistically significant. Correlations between MDGL and SLE indices were significant, rho=0.60-0.72 (p<0.001). Correlations between PTGL and patient measures also were significant, rho=0.58-0.87 (p<0.001). However, PTGL was correlated at lower levels with SLE indices - significantly with BILAG and SLAM (0.35-0.40; p<0.01), and not significantly with SLEDAI or ECLAM. MDGL was not correlated significantly with any patient measure or index. (Table Presented) Conclusion: MDGL and PTGL are not correlated significantly, an observation made previously. MDGL was correlated significantly with all physician-derived indices, and PTGL was correlated significantly with all patient-derived measures and indices. By contrast, MDGL was correlated at much lower, nonsignificant levels with patient-derived measures and indices, and PTGL was correlated at lower levels with physician-derived indices. Further analysis of these discordances may clarify the clinical relevance of various measures in clinical trials, and may lead to improved care and compliance in patients with SLE
— id: 130931, year: 2010, vol: 62, page: 1857, stat: Journal Article,

Differences in pain and fatigue perception among a group of rheumatoid arthritis patients in the United States and in Turkey who have similar disease activity and functional status
Celik, S; Fresko, I; Sut, N; Batumlu, N M; Yazici, H; Yazici, Y
2010 Nov-Dec;28(6):884-887, Clinical & experimental rheumatology
OBJECTIVES: The concordance of patient reported outcomes in rheumatoid arthritis (RA) among different countries has not been studied in detail. We tried to determine the differences in pain and fatigue perception among a group of RA patients in the US and in Turkey who had similar disease activity and functional score in multidimensional health assessment questionnaire (MDHAQ FN). METHODS: One hundred and thirty seven RA patients from Turkey and 129 from the US were studied. An MDHAQ was obtained and a DAS28 was calculated for each patient. Pain and fatigue perception was compared between the two groups after adjusting for age, sex, MDHAQ FN and DAS 28. RESULTS: Turkish patients had less pain than their US counterparts when adjusted for MDHAQ FN, DAS 28, age and sex (3.56 (2.24) vs. 4.35 (2.23), p=0.005) whereas there was no difference in fatigue between the two groups (3.85 (2.44) vs. 4.25 (2.45), p=0.194). When the patients with a DAS28 score of above 5.1 and below 2.6 were compared in both groups, Turkish patients had again less pain albeit less in the high disease activity group. CONCLUSIONS: This study suggests that Turkish patients have less pain than the US patients when controlled for age, gender and MDHAQFN and DAS28 scores. This is at odds to the conventional wisdom that pain perception is increased among the non-Western cultures
— id: 134408, year: 2010, vol: 28, page: 884, stat: Journal Article,

Headache in North American Patients with Behcet's Disease
Crystal, S. C.; Robbins, M. S.; Filopolous, M.; Kister, I.; Lipton, R. B.; Yazici, Y.
2010 AUG ;50(8):S20-S21, Headache
— id: 112184, year: 2010, vol: 50, page: S20, stat: Journal Article,

In systemic lupus erythematosus (SLE) patients, patient reported outcomes and physician assessment of disease activity are poorly correlated: Implications for outcome measures in SLE
Diaz M.V.; Shadakshari A.; McCracken A.; Swearingen C.; Ricciardi D.; Yazici Y.
2010 ;62:1863-1863, Arthritis & rheumatism
Purpose: To evaluate the correlation of patient vs physician reported outcome measures in a routine care SLE cohort. Methods: The first recorded physician global observations in patients with the primary diagnosis of systemic lupus were identified; corresponding demographic, patient reported functional outcomes and current usage of prednisone, hydroxychloroquine and non-steroidal anti-inflammatory medications and immunosupressive medication use were abstracted. Current medication usage was operational defined as medications taken prior to and including the visit date; patient discontinuations prior to the selected visit and medication initiations at the selected visit were defined as non-current usage. Summary statistics for demographic, outcome
— id: 130939, year: 2010, vol: 62, page: 1863, stat: Journal Article,

AN AUDIT OF BEHCETS SYNDROME RESEARCH: A 10-YEAR SURVEY
Esen, Fehim; Schimmel, Elizabeth K.; Yazici, Hasan; Yazici, Yusuf
2010 JUL-AUG ;28(4):S146-S146, Clinical & experimental rheumatology
— id: 114025, year: 2010, vol: 28, page: S146, stat: Journal Article,

Headache in North American Patients with Behcet's Syndrome: Common and important cause of disability
Filopoulos M; Robbins MS; Crystal SC; Kister I; Bacon T; Lipton; Labitigan M; Yazici Y
2010 ;69:S3-S3, Annals of rheumatic diseases
— id: 112006, year: 2010, vol: 69, page: S3, stat: Journal Article,

Treatment of rheumatoid arthritis: strategies for achieving optimal outcomes
Gibofsky, A; Yazici, Y
2010 JUN ;69(6):941-942, Annals of rheumatic diseases
— id: 110002, year: 2010, vol: 69, page: 941, stat: Journal Article,

Patients in the RAPIDI (Rheumatoid Arthritis Prevention of structural Damage) Clinical Trial of Certolizumab Pegol (CZP) Have Similar High/Moderate vs Low... Moderate and Poor Responses
Keystone, Edward; Fischer, Aryeh; Yazici, Yusuf; Bergman, Martin; Luijtens, Kristel
2010 JUN ;37(6):1294-1294, Journal of rheumatology
— id: 112180, year: 2010, vol: 37, page: 1294, stat: Journal Article,

Cross-Sectional Survey of Neurologic Dysfunction and Headaches in North American Patients with Behcet's Disease
Kister, I; Filopoulos, MT; Labitigan, MD; Crystal, S; Robbins, MS; Herbert, J; Yazici, Y
2010 ;74(9):A492-A492, Neurology
— id: 111992, year: 2010, vol: 74, page: A492, stat: Journal Article,

CROSS-SECTIONAL SURVEY OF NEUROLOGIC AND PSYCHIATRIC SYMPTOMS IN NORTH AMERICAN PATIENTS WITH BEHCET'S SYNDROME
Kister, Ilya; Filopoulos, Maria; Labitigan, Monalyn De Los Reyes; Crystal, Sara; Robbins, Matthew; Herbert, Joseph; Yazici, Yusuf
2010 JUL-AUG ;28(4):S112-S113, Clinical & experimental rheumatology
— id: 114024, year: 2010, vol: 28, page: S112, stat: Journal Article,

Eye involvement in Behcet's Syndrome patients in a North American cohort
Nowatzky J.; Filopoulos M.T.; Swearingen C.; Yazici Y.
2010 ;62:1298-1298, Arthritis & rheumatism
Background: Ocular disease has been reported in up to 75 % of patients with Behcet's Syndrome (BS) in endemic regions where permanent visual loss is common. The prevalence of eye disease in North American BS patients is unknown, but felt to be lower than in endemic regions. More prevalent and severe eye disease is expected in North American populations with an ethnic background in those regions. Methods: A BS center was established in New York City in 2004. Patients at the center completed an MDHAQ, BSAS (Behcet Syndrome Activity Score), questionnaires about past medical history, medication use, Behcet's specific history, ethnic and demographic information. These data were prospectively collected over 5 years and updated on each visit. Patients fulfilling the International Behcet's Classification Criteria were analyzed as one cohort and then in 2 groups: Group A= with ethnic background in northern/central Europe and North America and/or self declared Caucasians without Mediterranean, Middle Eastern and/or Far Eastern background; Group B= Patients with Mediterranean, Middle Eastern, North African, or Far Eastern ethnic background. These groups were compared for their prevalence, type and outcome of ocular disease. Results: 471 patients were seen for suspected BS. 296 (62.8%) fulfilled the International Behcet's Classification Criteria and were included in the present study. Of those, 121 (40.9%) patients had eye disease, which included 56 (18.9%) with uveitis, 8 (2.7%) with retinitis, 11 (3.7%) with episcleritis, and 42 (14.2%) with other eye disease. There was no statistically significant difference between Groups A (n=163) and B (n=133) regarding the prevalence of eye disease (41.1% vs. 40.6%, p<0.93), types of involvement: uveitis (19.6% vs. 18.0%, p<0.729), retinitis (1.8% vs. 3.8%, p<0.311), episcleritis (3.1% vs. 4.5%, p<0.514), baseline disease activity and use of immunosuppressive medications. None of the patients presented with or developed blindness during the study period. Conclusions: Eye involvement was less prevalent and seemed to have better outcomes in this North American cohort of BS patients than in cohorts studied in high-incidence/endemic BS regions. Contrary to our expectations, there was no significant difference in prevalence or outcome of Behcet's eye disease between North Americans of non-Mediterranean European ancestry compared to individuals of Mediterranean, Middle- or Far Eastern descent living in the US. These findings could suggest a role of environmental factors in the phenotypic expression of BS in general, and in the pathogenesis of Behcet's eye disease in particular
— id: 130936, year: 2010, vol: 62, page: 1298, stat: Journal Article,

Clues To differentiate non-inflammatory from inflammatory symptoms in patients with Systemic Lupus erythematosus (SLE), using a multi-dimensional health assessment questionnaire (MDHAQ)
Pincus T.; Castrejon I.; Buyon J.P.; Tseng C.-E.; Izmirly P.M.; Yazici Y.; Askanase A.D.
2010 ;62:990-990, Arthritis & rheumatism
Purpose: To analyze whether quantitative scores on a multidimensional health assessment questionnaire (MDHAQ) provide clues to the likelihood of inflammatory versus non-inflammatory symptoms and concomitant fibromyalgia, an important challenge in clinical care, according to a global scale for noninflammatory symptoms completed by a rheumatologist in 50 patients with SLE seen in usual care. Methods: A cross-sectional study was performed in 50 consecutive SLE patients of one rheumatologist seen in usual care. On arrival at the clinic, patients completed a multidimensional health assessment questionnaire (MDHAQ) which includes scales for physical function (FN), 0-10 visual analog scales for pain (PN), global estimate (PTGL) and fatigue (FT), and a review of systems symptom checklist (SX). SLE patients also completed a self-report Systemic Lupus Assessment Questionnaire (SLAQ). The rheumatologist, unaware of MDHAQ and SLAQ scores, recorded a physician global estimate (MDGL) and an estimate of non-inflammatory symptoms, each scored on a 0-3 scale in 0.1 increments, as well as four SLE indices: SLEDAI-2K (SLE Disease Activity Index), BILAG (British Isles Lupus Assessment Group index), SLAM (SLE Activity Measure) with and without laboratory tests, and ECLAM (European Consensus Lupus Activity Measurement). SLE patients with scores of <0.5 on the noninflammatory symptom scale were regarded as low and those with scores >=0.5 high noninflammatory symptoms; the two groups were compared using the Mann-Whitney statistic. Results: The study included 45 women and 5 men, mean age 38.7 years, mean disease duration 7.3 years. Of the 50 patients, 16 had high and 34 low scores for non-inflammatory symptoms. Those with high scores for non-inflammatory symptoms had significantly higher scores for FN, PN, FT, PTGL, SX, SLAQ, and SLAM without laboratory tests, as well as significantly lower CRP. No significant differences were seen patients estimated as high and low scoring patients for SLEDAI, BILAG, SLAM, ECLAM, C3, C4, antiDsDNA, or ESR. Fewer than 50% of low patients had FN, PN, PTGL, or FT >=2, while 100% of high patients had FT >2, and 94% PTGL >2. All patients with high non-inflammatory symptoms (16/16) reported more than 5 SX, compared to 15/34 (44%) low patients, and 12/16 (75%) high patients reported >10 SX, compared to 6/34 (18%) low patients. (Table Presented) Conclusion: High scores for dysfunction, pain, fatigue, global estimates, and number of symptoms are common in SLE patients with high versus low levels of non-inflammatory symptoms. SLE indices do not distinguish between patients with high versus low levels of non-inflammatory symptoms. A simple global scale to estimate non-inflammatory symptoms may be informative in therapeutic decisions, particularly if consistent with patient questionnaire patterns
— id: 130928, year: 2010, vol: 62, page: 990, stat: Journal Article,

A checklist of 10 measures, 6 from a patient questionnaire & 4 physician global scores, requiring <15 seconds, to provide quantitative patient history & physical examination data, analogous to laboratory tests, for usual clinical care
Pincus T.; Yazici Y.; Bergman M.J.; Sokka T.; Swearingen C.J.
2010 ;62:985-985, Arthritis & rheumatism
Purpose: To analyze a proposed checklist of 10 quantitative measures, 6 from a patient questionnaire and 4 physician global scores, compiled in less than 20 seconds, to provide quantitative patient history and physical examination (PE) data, which rheumatologists indicate are more important than laboratory tests in clinical decisions in usual care visits. Methods: The 6 quantitative patient measures are from a self-report multidimensional health assessment questionnaire (MDHAQ) for: physical function (FN) (0-10); 21 circle 0-10 visual analog scales for pain (PN), patient global estimate (PTGL), and fatigue (FT); review of 60-symptom checklist (SX); and RAPID3, a 0-30 total of FN+PN+PTGL whcih requires 5 seconds. The 6 scores are compared on a flow sheet to scores at previous visits prior to the traditional patient encounter. The rheumatologist records 4 global estimates for: overall status (0-10), and 3 0-3 global scales for levels of inflammatory activity, joint or other organ damage, and non-inflammatory/fibromyalgia symptoms, recoded 0-10 to compare to other measures. An updated flow sheet report includes the 10 proposed checklist scores, as well as laboratory tests and medications. Mean 1st visit values for the 10 proposed checklist measures were analyzed in all 874 new patients seen at a weekly academic setting from 1996-2007 in 8 groups: rheumatoid arthritis (RA), osteoarthritis (OA), fibromyalgia (FM), systemic lupus erythematosus (SLE), gout, spondyloarthropathy (Spondy), inflammatory polyarthritis (InflPol), connective tissue disease (CTD), and other, as well as demographic data, ESR and CRP, compared using Spearman rank order correlations. Results: The 874 patients appear typical for rheumatic diseases (Table). ESR was >20 mm/Hr in RA, OA, SLE, Spondy, and CTD, while CRP was >10 mg/dL in RA and Spondy. Mean MDHAQ FN was highest in RA and also >3.0 in FM and Spondy. Mean PAIN was highest in FM, and >5 in Spondy, RA and InflPol; PTGL >5 in FM, RA and Spondy; FT >5 in FM, RA, SLE, InflPol, and other. Symptom scores were >20 only in FM. Mean MD global estimates were >=5.0 in all 8 categories - mean 5.7. Estimates were >5 for inflammation in Spondy, RA, gout, InflPol, and CTD; for damage only in RA and OA; and for noninflam/fibro symptoms in FM, SLE, and other. Quantitative demographic, laboratory tests, patient MDHAQ scores, and MD global estimates in 874 new rheumatology patients, by diagnosis, Spondy = Spondylarthropathies. InflPol = Inflammatory Polyarthritis. (Table presented) Conclusion: A proposed checklist of 10 measures, 6 from a MDHAQ and 4 global MD scores, provides quantitative data from a history and PE at each encounter in the infrastructure of rheumatology care, in <20 seconds. These data provide quantitative measures to assess patient status over long periods, treat to target values, and may lead to improved patient outcomes
— id: 130920, year: 2010, vol: 62, page: 985, stat: Journal Article,

RAPID3 (Routine Assessment of Patient Index Data) on an MDHAQ (Multidimensional Health Assessment Questionnaire): Agreement with DAS28 (Disease Activity Score) and CDAI (Clinical Disease Activity Index) activity categories, scored in five versus more than ninety seconds
Pincus, Theodore; Swearingen, Christopher J; Bergman, Martin J; Colglazier, C Lee; Kaell, Alan T; Kunath, Arthur M; Siegel, Evan L; Yazici, Yusuf
2010 Feb;62(2):181-189, Arthritis care & research
OBJECTIVE: To compare the Routine Assessment of Patient Index Data 3 (RAPID3) on a Multidimensional Health Assessment Questionnaire (MDHAQ) with the Disease Activity Score (DAS28), Clinical Disease Activity Index (CDAI), and individual core data set measures for correlations, agreement of activity levels, and time to score. METHODS: Four rheumatologists each assessed 50 patients with rheumatoid arthritis in 'real-time' clinical care. Patients completed an MDHAQ. The rheumatologist then calculated RAPID3 (physical function, pain, patient global estimate), performed a 28-joint count, assigned a physician global estimate, and scored a CDAI, each timed by an observer. Erythrocyte sedimentation rate (ESR) was tested on the same date, and the DAS28-ESR was computed later, again timed by an observer. Spearman's rank-order correlations and comparisons of patients classified as high activity, moderate activity, low activity, and remission according to the DAS28, CDAI, and RAPID3 were computed and compared with kappa statistics. A second study of 25 'paper patients' was also performed to compare time to score the DAS28, CDAI, and RAPID3 on a 0-10 versus 0-30 scale. Mean and median times to score each index were computed. RESULTS: The 3 indices were correlated significantly, including agreement for >80% of patients for high/moderate activity. The mean time to perform a 28-joint count was 94 seconds, and the mean times to score the DAS28, CDAI, RAPID3 on a 0-10 scale, and RAPID3 on a 0-30 scale were 114, 106, 9.6, and 4.6 seconds, respectively. CONCLUSION: RAPID3 scores provide similar quantitative information to DAS28 and CDAI, while calculated on a 0-30 scale in about 5% of the time
— id: 107785, year: 2010, vol: 62, page: 181, stat: Journal Article,

Beyond RAPID3 - practical use of the MDHAQ to improve doctor-patient communication
Pincus, Theodore; Yazici, Yusuf; Bergman, Martin J
2010 ;68(3):223-231, Bulletin of the NYU Hospital for Joint Diseases
A multidimensional health assessment questionnaire (MDHAQ) can enhance doctor-patient communication beyond the important function of providing RAPID3 scores, preparing the patient for the encounter and saving time for the doctor. Optimal use of the MDHAQ should include the following actions: 1. the MDHAQ should be distributed to each patient at each visit in the infrastructure of care; 2. the MDHAQ helps the patient prepare for the visit by completing it in the waiting area prior to seeing the physician; 3. the clinician prepares for the visit and saves time by reviewing the MDHAQ before seeing the patient; 4. the clinician scans the review of systems and records the number of positives on the symptom checklist; 5. the clinician reviews the recent medical history information to save time and improve accuracy and completeness of critical information; and 6. routine Assessment of Patient Index Data 3 (RAPID3) scores are recorded in the medical record and entered into a flowsheet, which also includes other MDHAQ scores, laboratory tests, and medications
— id: 114057, year: 2010, vol: 68, page: 223, stat: Journal Article,

Chronic Daily Headache in North American Patients with Behcet's Disease
Robbins, M. S.; Crystal, S. C.; Filopoulos, M.; Kister, I.; Bacon, T.; Lipton, R. B.; Yazici, Y.
2010 AUG ;50(8):S16-S16, Headache
— id: 112183, year: 2010, vol: 50, page: S16, stat: Journal Article,

Safety and clinical efficacy of golimumab in the treatment of arthritides
Simsek, Ismail; Yazici, Yusuf
2010 ;2:169-180, Drug, Healthcare & Patient Safety
Golimumab is a human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody that was recently approved for the treatment of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. This review covers the published clinical trial data on the use of golimumab for the approved indications mentioned above with respect to efficacy and safety. The various ongoing trials for golimumab have yielded promising results in terms of efficacy and safety in methotrexate-naive and -resistant patients with rheumatoid arthritis, as well as in patients who were previously treated with other anti-TNF agents. In addition, the efficacy of golimumab in psoriatic arthritis and ankylosing spondylitis has also been demonstrated. The real safety information will be available only once the drug has been used in many more patients, who frequently have comorbid conditions
— id: 134733, year: 2010, vol: 2, page: 169, stat: Journal Article,

Informed consent: One size does not fit all
Yazici Y.
2010 ;(JANUARY-FEBRUARY):4-5, Oncology Report
— id: 109841, year: 2010, vol: , page: 4, stat: Journal Article,

Efficacy and safety of tocilizumab in patients with moderate to severe active RA and a previous inadequate response to DMARDs: The ROSE study
Yazici Y.; Curtis J.R.; Ince A.; Baraf H.; Malamet R.L.; Chung C.Y.; Kavanaugh A.
2010 ;62:1808-1808, Arthritis & rheumatism
Purpose: Early and aggressive treatment of RA has been associated with improved outcomes. The objective of the Rapid Onset and Systemic Efficacy (ROSE) study was to assess the efficacy of tocilizumab (TCZ) versus placebo in combination with DMARDs in reducing signs and symptoms during 24 weeks of treatment in patients with moderate to severe RA who have had inadequate clinical response to DMARDs. Methods: 619 patients were randomly assigned to TCZ 8 mg/kg + DMARDs (TCZ, n=412) or placebo + DMARDs (control, n=207). The primary efficacy end point was ACR50 response at week 24. Efficacy parameters were assessed every 4 weeks through week 24. Disease activity was also assessed at 1 week for a subset of 62 patients. Safety and laboratory parameters were assessed throughout the study. Results: Most patients were female (81%) and Caucasian (81%); mean age was 55 y, mean disease duration was 8.6 y, mean number of previous DMARDs was 1.2, and mean DAS28 was 6.5. At week 24, there was a significantly higher percentage of ACR50 responders (primary end point) in the TCZ group than in the control group (30.1% vs 11.2%; p<0.0001). Significantly higher percentages of patients in the TCZ group than in the control group achieved ACR20 and ACR50 responses from week 4 through week 24 and ACR70 responses from week 8 through week 24 (Table). Patients in the TCZ group had significant improvement in RAPID3 scores from week 4 through week 24 and in FACIT-Fatigue scores from week 8 through week 24 compared with control (Table). In the TCZ group, improvements in CRP and Hb levels occurred early (week 4) and were sustained through week 24; CRP improvement was significant at all time points (p<0.0001). In the subset, DAS28 and patients' pain and global assessment scores significantly improved, and CRP levels normalized 1 week after TCZ treatment (p<=0.01 vs control). SAE rates/100 PY (95% CI) were 24 (17, 33) and 19 (11, 31) for the TCZ and control groups, respectively. Serious infections were reported in 2.9% and 0.5% of patients in the TCZ and control groups, respectively. Malignancies were reported in 0.7% and 1.5% of patients in the TCZ and control groups, respectively. ALT shifts from normal at baseline to >3x ULN occurred in 3.2% of TCZ patients and in 1.1% of control patients. Clinically significant (grade 3/4) decreases in neutrophil counts were reported in 2.9%/0% of TCZ patients; no grade 3/4 decreases were reported in control patients. There were no occurrences of decreased platelet counts to clinically significant values (grade 3/4). Conclusions: TCZ led to significant improvements in disease activity, ACR responses, and CRP and Hb levels as early as week 4 and in DAS28 response as early as week 1; responses persisted through week 24. Safety findings were consistent with the known safety profile of TCZ. With early and sustained efficacy, TCZ is an effective treatment option for patients with RA who have failed DMARDs. (Table Presented)
— id: 130934, year: 2010, vol: 62, page: 1808, stat: Journal Article,

ERA patients treated with abatacept and MTX have a higher chance of improvements in signs, symptoms and physical function than treated with MTX alone
Yazici Y.; Moniz Reed D.; Covucci A.; Becker J.C.; Westhovens R.
2010 ;16:S28-S29, Journal of clinical rheumatology. JCR
EULAR/ACR stress the importance of reporting the sustainability of treatment responses in patients with RA. Here we show the likelihood of maintaining/improving initial improvements in the signs, symptoms of RA and physical function with abatacept over 1 year, in MTX-naive patients with ERA and poor prognostic factors. Methods: In the 12-month double-blind period of AGREE study, patients with RA 2 years and poor prognostic factors received abatacept (~10 mg/kg)+MTX or MTX alone. In these post-hoc analyses, shifts in ACR response and HAQ-DI status from Month 3 to 12 were evaluated in pts who completed the
— id: 135286, year: 2010, vol: 16, page: S28, stat: Journal Article,

Long-term safety of methotrexate in the treatment of rheumatoid arthritis
Yazici, Y
2010 Sep-Oct;28(5 Suppl 61):S65-S67, Clinical & experimental rheumatology
Methotrexate (MTX) has been the anchor treatment in rheumatoid arthritis (RA) over the last 15 years, and is used in combination with biologic agents to enhance efficacy over the last decade or so. The safety profile of MTX has been studied over 25 years with very few clinically important adverse events in the weekly low-doses used for RA treatment. The importance of MTX in earlier and more aggressive management of RA patients cannot be overstated. MTX courses show some of the longest continuation rates reported in clinical medicine, due to both effectiveness and safety. The safety profile of MTX indicates that it is among the safest of any mediation used for the treatment of any arthritis. Better information on the effectiveness and safety of weekly-low dose MTX should be communicated to all health professionals involved in the management of RA patients
— id: 114832, year: 2010, vol: 28, page: S65, stat: Journal Article,

Comment on: Web resources for rare auto-inflammatory diseases: towards a common patient registry
Yazici, Y; Yazici, H
2010 JAN ;49(1):198-198, Rheumatology (Oxford)
— id: 106445, year: 2010, vol: 49, page: 198, stat: Journal Article,

Informed consent--practical considerations
Yazici, Yusuf
2010 ;68(2):127-129, Bulletin of the NYU Hospital for Joint Diseases
Informed consent is a legal document that summarizes what will take place in a study in a language the study subjects can understand and is the process by which a person decides whether or not to participate in a study. The document is not limited to explaining the intervention or potential risks and benefits but is also the source of understanding why the study is being done and what the particular study will add to what is already known. Overall, informed consent is a document providing important transparency and clarity about the study. While consent forms are mandatory prior to study approval by internal review boards, they are not published as part of study results and are not part of clinical trial registries. The central role of an informed consent document in any study could be vitally expanded and enhanced with inclusion and full disclosure of its content through clinical trial registries and published reports in the literature, bringing improved transparency to the entire clinical trial process. Transparency is important for the maintenance of high standards in clinical research and for public trust of the process, a sometimes underrecognized factor in healthcare initiatives
— id: 111384, year: 2010, vol: 68, page: 127, stat: Journal Article,

Severe adverse reactions are rare with infusions of infliximab in a community setting
Yazici, Yusuf
2010 Oct;13(4):107-108, Evidence-based nursing
— id: 112558, year: 2010, vol: 13, page: 107, stat: Journal Article,

BEHCET\'S SYNDROME IN THE UNITED STATES: CLINICAL CHARACTERISTICS, TREATMENT AND ETHNIC/RACIAL DIFFERENCES IN MANIFESTATIONS OF 518 PATIENTS
Yazici, Yusuf; Filopoulos, Maria; Schimmel, Elizabeth; Mccraken, Andy; Swearingen, Christopher
2010 JUL-AUG ;28(4):S156-S156, Clinical & experimental rheumatology
— id: 114026, year: 2010, vol: 28, page: S156, stat: Journal Article,

Treatment options for rheumatoid arthritis beyond TNF-alpha inhibitors
Yazici, Yusuf; Simsek, Ismail
2010 Sep;3(5):663-666, Expert Review of Clinical Pharmacology
The treatment of rheumatoid arthritis has changed over the last 15 years. Early and aggressive treatment, use of methotrexate as the anchor drug and combination treatment, with older disease-modifying drugs or biologics, have become the norm. TNF inhibitors were the first biologic agents available to rheumatologists and are still currently used as first-line biologics, in addition to other newer biologic agents. Abatacept, rituximab and tocilizumab are available biologics that use a different mode of action to TNF inhibitors, and can be used after a TNF inhibitor is tried. Abatacept is also currently used as a first-line biologic and others can also be used once data are available
— id: 141980, year: 2010, vol: 3, page: 663, stat: Journal Article,

Informed consent: time for more transparency
Yazici, Yusuf; Yazici, Hasan
2010 ;12(3):121-121, Arthritis research & therapy
ABSTRACT : Informed consent is not only for documenting a patient's acceptance of enrolling in a clinical trial. It currently is the patient's and, we propose, should also be the public's main source of information regarding the reasons for the planned study, what is known in the field about the proposed trial, and what to expect as far as efficacy and harm. Informed consent is not currently part of the clinical trial registries. For purposes of full disclosure to the patients and the public, the informed consent should be part of the required documents for such registries
— id: 111353, year: 2010, vol: 12, page: 121, stat: Journal Article,

Behcet's syndrome
Yazici, Yusuf; Yurdakul, Sebahattin; Yazici, Hasan
2010 Dec;12(6):429-435, Current rheumatology reports
Behcet's syndrome is a systemic vasculitis with an unknown etiology affecting the small and large vessels of the venous and arterial systems. At least two clusters of disease expression have been described. The first includes superficial vein thrombosis, deep vein thrombosis, and dural sinus thrombi. The second includes acne, arthritis, and enthesitis. The presence of these clusters suggests there may be more than one disease mechanism operative in this complex disorder. Recent European League Against Rheumatism guidelines are useful for the management of the disease in organ systems distinct from the vascular, neurological, and gastrointestinal systems. This is because of a lack of controlled studies evaluating such vascular, neurological, and gastrointestinal complications
— id: 113805, year: 2010, vol: 12, page: 429, stat: Journal Article,

The COX-2 inhibitor market withdrawals and prescribing patterns by rheumatologists in patients with gastrointestinal and cardiovascular risk
Greenberg, J D; Fisher, M C; Kremer, J; Chang, H; Rosenstein, E D; Kishimoto, M; Lee, S; Yazici, Y; Kavanaugh, A; Abramson, S B
2009 May-Jun;27(3):395-401, Clinical & experimental rheumatology
OBJECTIVE:To examine effects of the COX-2 inhibitor market withdrawals on NSAID utilization among patients at increased risk of gastrointestinal (GI) and cardiovascular (CV) toxicities. METHODS:A prospective cohort study was conducted using patients enrolled in the Consortium of Rheumatology Researchers of North America (CORRONA) Registry. The study population included rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients prescribed NSAIDs by rheumatologists from 1/1/2003 to 12/31/2005. Three cohorts were defined based on calendar year. The primary outcome assessed whether or not an NSAID gastroprotective strategy was prescribed. Secondary outcomes included rates of COX-2 inhibitor utilization and gastroprotective co-therapy utilization, stratified by the presence of cardiac and GI risk factors. RESULTS:NSAID gastroprotection utilization decreased from 65.1% in 2003 to 47.7% (p<0.001) in 2005. COX-2 inhibitor use decreased from 55.1% to 29.2% (p<0.001), whereas nonselective NSAIDs (nsNSAIDs) use increased from 50.2% to 73.9% (p=<0.01). Among patients with two or more risk factors for NSAID related GI bleeding, gastroprotection decreased from 74.4% in 2003 to 60.9% (p<0.01). For patients with two or more CV risk factors from 2003 to 2005, COX-2 inhibitor utilization decreased significantly, whereas nsNSAID utilization increased significantly.CONCLUSIONS:The COX-2 inhibitor withdrawals resulted in a rapid decline in NSAID gastroprotection prescribed by participating U.S. rheumatologists despite the availability of other gastroprotective options. Channeling toward nsNSAID use was widespread, including among patients at increased CV risk. Longer term follow-up is required to determine the clinical significance of these changes in NSAID prescribing, particularly for NSAID-related GI and CV-related toxicities
— id: 100676, year: 2009, vol: 27, page: 395, stat: Journal Article,

Wrist pain in 712 year olds playing with game consoles/handhelds: Younger children have more pain, independent from time spent playing
Ince D.C.; Swearingen C.J.; Yazici Y.
2009 ;60:1234-1234, Arthritis & rheumatism
Purpose: Game consoles such as Xbox, PS3 and Wii, in addition to handheld unit PSP, iTouch and iPhone are used by many children. Data regarding wrist and finger pain that may be caused by excessive use of these devices do not exist, especially in young children. We examined the possible association device type, age of children and hours played may have with wrist and finger pain. Method: 7-12 year olds attending Rossman Elemantary School in St Louis, MO, were administered a questionnaire asking about game consoles and hand-held devices used, hours played, and wrist or finger pain as reported on a 10cm VAS. Summary statistics of playing habits, devices played and pain levels were estimated. Multivariable generalized linear models associating consoles played, age and hours played to pain were constructed using standard backward selection techniques, determining the most significant independent predictors for pain. Results: 171 children completed the survey (mean age 9.7 years, 93 were female (54.4%). 84 (49.1%) reported 0-1 hours of play a day, 58 (33.9%) 1-2 hours, 12 (7%) 2-3 hours and 11 (6.4%) over 3 hours. 20 (11.7%) children reported finger pain and 17 (9.9%) reported wrist pain limiting their playing time. The mean (SD) pain level was 0.83 (1.82). Among the consoles Wii was the most commonly used (n=77, 45%), followed by Xbox/PS3 (n=9, 5.3%). 28 (16.4%) children played with none and 57 (33.3%) played both. For handhelds, Gameboy/PSP were played by 103 (60.2%) and iTouch/iPhone by 10 (5.8%). 39 (22.8%) played both and 19 (11.1%) played with neither. In beta regression, increasing age was independently associated with decreased odds of reporting pain (OR=0.65 (95% CI 0.57 - 0.75)); increasing hours played was associated with increased odds of reporting pain (OR=1.52 (95% CI 1.16-2.00)). Playing the Wii only was also independently associated with increased odds of reporting pain (OR=2.39 (95% CI 1.81-3.73)). In logistic regression, age was the only significant predictor of wrist pain (OR=0.68 (95% CI 0.48-0.96).No significant predictor of finger pain was observed. Conclusion: In children aged 7-12, 80% of which played with a console or handheld, younger age was associated with more wrist pain. Wii use was associated with more self-reported pain independent of age and hours played. Seven year olds reported the most pain as compared the other age groups. These findings may have implications for which age children should start playing with gaming consoles and handheld devices and possibly some limits in the hours they play
— id: 130351, year: 2009, vol: 60, page: 1234, stat: Journal Article,

Reevaluation of the Role of Duration of Morning Stiffness in the Assessment of Rheumatoid Arthritis Activity
Khan, NA; Yazici, Y; Calvo-Alen, J; Dadoniene, J; Gossec, L; Hansen, TM; Huisman, M; Kallikorm, R; Muller, R; Liveborn, M; Oding, R; Luchikhina, E; Naranjo, A; Rexhepl, S; Taylor, P; Tlustochowich, W; Tsirogianni, A; Sokka, T
2009 NOV ;36(11):2435-2442, Journal of rheumatology
Objective. To evaluate file utility of the duration of morning stiffness (MS), as a patient-reported Outcome (PRO), in assessing rheumatoid arthritis (RA) disease activity. Methods. We acquired information oil 5439 patients in QUEST-RA, ail international database of patients with RA evaluated by a standard protocol. MS duration was assessed from time of waking to time of maximal improvement. Ability of MS duration to differentiate RA activity states. based on Disease Activity Score (DAS)28, was assessed by analysis of variance; and a receiver-operating, characteristic (ROC) Curve was plotted for discriminating clinically active (DAS28 > 3.2) from less active (DAS28 :5 3.2) RA. Mixed-effect analysis of covariance (ANCOVA) models were used to assess the utility of adding MS duration to Routine Assessment of Patient Index Data (RAPID)3, a PRO index based on physical function, pain, and general health (GH), in predicting the 3-variable DAS28 (DAS28v3). Results. MS duration had moderate correlation (r = 0.41-0.48) with pain, Health Assessment Questionnaire, and GH; and weak correlation (r = 0.23-0.39) with joint counts and erythrocyte sedimentation rate. MS duration differed significantly among patients with different RA activity (p < 0.001). The area under the ROC Curve of 0.74 (95% CI 0.72-0.75) showed moderate ability of MS duration to differentiate clinically active from less active RA. ANCOVA showed significant interactive effects between RAPID3 and the MS duration categories (p = 0.0005) in predicting DAS28v3. The effect of MS was found to be clinically important in patients with the low RAPID3 scores (< 6) in whom the presence of MS may indicate clinically active disease (DAS28v3 > 3.2). Conclusion. MS duration has a moderate correlation with RA disease activity. Assessment of MS duration may be clinically helpful ill patients with low RAPID3 scores. (First Release Oct 15 2009; J Rheumatol 2009;36:2435-42; doi: 10.3899/jrheum.081175)
— id: 105631, year: 2009, vol: 36, page: 2435, stat: Journal Article,

Comparison of rapid3, basdai and basfi in ankylosing spondylitis patients in routine care: RAPID3, composed of patient measures only, is strongly correlated with BASDAI and BASFI
Kurtulus D.; Bahadir C.; Swearingen C.J.; Yazici Y.
2009 ;60:510-510, Arthritis & rheumatism
Purpose: The Bath ankylosing spondylitis disease activity index (BASDAI) and Bath AS Function Index (BASFI) were developed as outcome measures to assess and monitor patients with ankylosing spondylitis (AS). Although widely used in clinical trials and other clinical research, these questionnaires are not commonly used in routine clinical care. It is complex to distribute multiple questionnaires to different patients in a reception area. A single questionnaire for all patients with rheumatic diseases may present advantages to introduce quantitative measurement into routine care. A multidimensional health assessment questionnaire (MDHAQ) has been developed to be used as part of the infrastructure of routine care and has been used in the clinics of the senior author for close to 10 years in every patient with any diagnosis. Routine assessment of patient index data 3 (RAPID3) is a composite index based on 3 MDHAQ components, patient function, pain and patient global assessment, each scored 0-10 for a total of 0-30. The MDHAQ has been shown to be useful in RA, OA, fibromyalgia and Behcet's syndrome. Method: Consecutive AS patients seen at Haydarpasa Numune Training and Research Hospital, Physical Medicine and Rehabilitation Outpatient Clinic in Istanbul, Turkey, between May 18 and June15, 2009 were enrolled. All patients completed a BASDAI (score range 0-10), BASFI (score range 0-10) and MDHAQ and had medical records reviewed for additional demographic information, disease characteristics, medication use and selected laboratory test results. Spearman correlations were computed for components of MDHAQ and RAPID3 (score range 0-30) with BASDAI and BASFI. Results: 51 AS patients were assessed (mean (SD) age:30 (10.9) 69% male, disease duration: 5.0 (6.7) years). Mean scores for BASDAI, BASFI and RAPID3 were 4.9 (2.5), 3.6 (2.5) and 12.9 (7.0), respectively. RAPID3 was strongly correlated with BASDAI and BASFI (r:0.77, and 0.72, p<0.001). Individual components of the MDHAQ (pain r:0.72, 0.6) patient's global assessment (r:0.8, 0.65), function (r:0.5, r:0.73), MD global assessment (r:0.7, r:0.76) and fatigue (r:0.62, r: 0.53) (all p<0.01), were also correlated significantly with both BASDAI and BASFI, respectively. Conclusion: RAPID3, on an MDHAQ was strongly correlated with the outcome measures of BASDAI and BASFI in AS patients. Additional measures in the MDHAQ were also correlated. This extends findings that an index of patient measures, RAPID3, may provide a user-friendly index and an effective measure in clinical care of individual patients with AS
— id: 130323, year: 2009, vol: 60, page: 510, stat: Journal Article,

Utilization Trends of Tumor Necrosis Factor Inhibitors Among Patients with Rheumatoid Arthritis in a United States Observational Cohort Study
Lee, SJ; Chang, H; Yazici, Y; Greenberg, JD; Kremer, JM; Kavanaugh, A
2009 AUG ;36(8):1611-1617, Journal of rheumatology
Objective. Studies have suggested that early institution of tumor necrosis factor (TNF) inhibitors improves functional status and slows radiographic progression among patients with rheumatoid arthritis (RA). To determine whether these findings have altered practice patterns, we used the Consortium of Rheumatolooy Researchers of North America (CORRONA) registry to assess the pattern of TNF inhibitor utilization in the US over time. Methods. Demographics and disease activity data were collected for patients with RA. The trend of TNF inhibitor use during 2002-06 was evaluated prospectively using linear and logistic regression models. Results. Of the 1 1 397 patients with RA, 66% and 34% had established RA and early RA (disease duration < 3 yrs), respectively. The majority of patients were female and Caucasian. Despite comparable levels of disease activity, more of the patients with established RA were taking TNF inhibitors than those with early RA (40% vs 25%; p < 0.0001). The majority of patients (70%) taking TNF inhibitors were also receiving disease modifying antirheumatic drugs. The use of TNF inhibitors increased at a rate of 2.8% per year in established RA and 1.2% per year in early RA. The mean Clinical Disease Activity Index at the start of TNF inhibitors decreased at a rate of -0.233 per quarter (p = 0.006), while the mean Disease Activity Score decreased at a rate of -0.04 per quarter (p = 0.022). Conclusion. Utilization of TNF inhibitors in this multicenter, observational US cohort is increasing in both early and established RA, although it is more prominent among patients with established RA. The level of disease activity at which TNF inhibitors were initiated decreased over time in patients with both established and early RA. (First Release April 15 2009; J Rheumatol 2009;36:1611-7; doi:10.3899/jrheum.080889)
— id: 101937, year: 2009, vol: 36, page: 1611, stat: Journal Article,

Dr. Pincus, et al reply
Pincus T.; Yazici Y.; Bergman M.J.
2009 ;36(2):456-, Journal of rheumatology
— id: 100471, year: 2009, vol: 36, page: 456, stat: Journal Article,

Complex measures and indices for clinical research compared with simple patient questionnaires to assess function, pain, and global estimates as rheumatology "vital signs" for usual clinical care
Pincus, Theodore; Bergman, Martin J; Maclean, Ross; Yazici, Yusuf
2009 Nov;35(4):779-86, ix, Rheumatic diseases clinics of North America
Indices of multiple measures have been developed to assess and monitor patients with rheumatic diseases, as no single 'gold standard' measure is available for diagnosis, prognosis, and monitoring of all individual patients. Rheumatology indices generally include 4 types of measures from a standard medical evaluation: patient history, physical examination, laboratory tests, and imaging studies. Well-characterized indices are available for rheumatoid arthritis (RA), psoriatic arthritis, systemic lupus erythematosus (SLE), ankylosing spondylitis, vasculitis, osteoarthritis, fibromyalgia, and other rheumatic diseases. These indices are complex and applied widely in clinical research, but rarely are scored in usual rheumatology patient encounters, which generally are conducted without quantitative data other than laboratory tests. Information from a patient often is as prominent in clinical decisions as information from a physical examination or laboratory tests, and is easily collected as standardized 'scientific' data on patient questionnaires designed for usual clinical care, which require minimal professional effort. Patient-derived data-along with physical examination, laboratory, and imaging data-are useful rheumatology 'vital signs' to assess and monitor patient status, provide documentation, and improve the quality of clinical care, in addition to their possible value for clinical research. Differences between complex measures for research and simple questionnaires designed for usual clinical care might be more widely recognized, to promote quantitative measurement in the infrastructure of usual rheumatology care
— id: 105662, year: 2009, vol: 35, page: 779, stat: Journal Article,

RAPID3-an index of physical function, pain, and global status as "vital signs" to improve care for people with chronic rheumatic diseases
Pincus, Theodore; Bergman, Martin J; Yazici, Yusuf
2009 ;67(2):211-225, Bulletin of the NYU Hospital for Joint Diseases
A guide to RAPID3 (routine assessment of patient index data), an index of three patient self-report measures-physical function, pain, and patient global estimate of status-on a multidimensional health assessment questionnaire (MDAQ) is presented, including development, scoring, use in standard care, and rationale. RAPID3 and its individual components are regarded as 'vital signs,' which may alert a health professional to unsuspected patient problems, provide a baseline measure to support a change in therapy, and numerically document improvement or worsening over time to complement clinical impressions. MDHAQ-RAPID3 can be incorporated into the infrastructure of standard rheumatology care for completion in the waiting room by every patient with any rheumatic disease at every visit: if there is a reason for a visit, there is a reason for RAPID3 vital signs. RAPID3 is calculated in 5 to 10 seconds, providing similar information to DAS28 (disease activity score) and CDAI (clinical disease activity index), which require a mean of 114 and 106 seconds, respectively. MDHAQ-RAPID3 presents an additional advantage for the patient to optimize the office encounter by completion of the questionnaire in the waiting room. The MDHAQ also includes a review of systems and recent medical history, which can save 2 to 3 minutes per visit for other patient concerns. A physician's clinical decisions ultimately require synthesis and interpretation of all available data, ranging from laboratory tests to patient questionnaire scores. RAPID3 vital signs can contribute to this synthesis toward improved quality, outcomes, and documentation of rheumatology care
— id: 101123, year: 2009, vol: 67, page: 211, stat: Journal Article,

Quantitative assessment of musculoskeletal conditions in standard clinical care : an issue of Rheumatic Disease Clinics
Pincus, Theodore; Yazici, Yusuf
[S.l.] : WB Saunders, 2009,
— id: 1944, year: 2009, vol: , page: , stat: ,

Patient questionnaires in rheumatoid arthritis: advantages and limitations as a quantitative, standardized scientific medical history
Pincus, Theodore; Yazici, Yusuf; Bergman, Martin J
2009 Nov;35(4):735-43, vii, Rheumatic diseases clinics of North America
In many chronic diseases, objective gold standard measures such as blood pressure, cholesterol, and bone densitometry often provide most of the information used to establish a diagnosis and guide therapy. By contrast, in inflammatory rheumatic diseases, information from a patient history usually is considerably more prominent in clinical management. Patient history data can be recorded as standardized, quantitative scientific data through use of validated self-reported questionnaires. Patient questionnaires address the primary concerns of patients and their families. Questionnaire scores distinguish active from control treatments in clinical trials at similar levels to swollen and tender joint counts or laboratory tests. Patient questionnaire data are correlated significantly with joint counts, radiographic scores, and laboratory tests, but usually are far more significant than these measures in the prognosis of severe outcomes of rheumatoid arthritis (RA), including work disability, costs, and premature death. Limitations of patient questionnaires are based on cultural features involving variation in responses among ethnic groups, and a need for translation, although translated questionnaires can be as valuable as a translator. Patient questionnaires do not replace further medical history, physical examination, laboratory tests, and imaging data, and they require interpretation in a context of these standard sources of information at any clinical encounter. Patient questionnaires are useful to monitor patient status in usual clinical care, with almost no effort on the part of the physician and staff if distributed by the receptionist in the infrastructure of office practice
— id: 105660, year: 2009, vol: 35, page: 735, stat: Journal Article,

Quantitative Clinical Rheumatology: Why Is a Test for Anti-CCP Antibodies Included in Most Routine Care for Rheumatoid Arthritis While a HAQ/MDHAQ Remains Largely a Research Tool?
Pincus, Theodore; Yazici, Yusuf; Bergman, Martin J
2009 Aug;36(8):1563-1564, Journal of rheumatology
— id: 101455, year: 2009, vol: 36, page: 1563, stat: Journal Article,

RAPID3, an index to assess and monitor patients with rheumatoid arthritis, without formal joint counts: similar results to DAS28 and CDAI in clinical trials and clinical care
Pincus, Theodore; Yazici, Yusuf; Bergman, Martin J
2009 Nov;35(4):773-8, viii, Rheumatic diseases clinics of North America
RAPID3 (routine assessment of patient index data 3) is a pooled index of the 3 patient-reported American College of Rheumatology rheumatoid arthritis (RA) Core Data Set measures: function, pain, and patient global estimate of status. Each of the 3 individual measures is scored 0 to 10, for a total of 30. Disease severity may be classified on the basis of RAPID3 scores: >12 = high; 6.1-12 = moderate; 3.1-6 = low; < or =3 = remission. RAPID3 scores are correlated with the disease activity score 28 (DAS28) and clinical disease activity index (CDAI) in clinical trials and clinical care, and are comparable to these indices in capacity to distinguish active from control treatments in clinical trials. RAPID3 on a multidimensional health assessment questionnaire (MDHAQ) is scored in 5 to 10 seconds, versus 90 to 94 seconds for a formal 28-joint count, 108 seconds for a CDAI, and 114 seconds for a DAS28. An MDHAQ can be completed by each patient at each visit in the waiting room in 5 to 10 minutes, as a component of the infrastructure of routine care, with minimal effort of the rheumatologist and staff, to provide RAPID3 scores as well as additional data including a self-report joint count, fatigue, review of systems, and recent medical history. In all rheumatic diseases RAPID3 is able to provide a baseline quantitative value, and to quantitatively monitor and document improvement or worsening over time
— id: 105661, year: 2009, vol: 35, page: 773, stat: Journal Article,

Complexities in assessment of rheumatoid arthritis: absence of a single gold standard measure
Pincus, Theodore; Yazici, Yusuf; Sokka, Tuulikki
2009 Nov;35(4):687-97, v, Rheumatic diseases clinics of North America
The clinical approach to patients with inflammatory rheumatic diseases differs substantially from the approach to patients with many typical chronic diseases, such as hypertension or diabetes. Further elucidation of these differences may be informative in efforts to advance quantitative scientific patient assessment and management in rheumatic diseases, with improved patient outcomes
— id: 105656, year: 2009, vol: 35, page: 687, stat: Journal Article,

Quality control of a medical history: improving accuracy with patient participation, supported by a four-page version of the multidimensional health assessment questionnaire (MDHAQ)
Pincus, Theodore; Yazici, Yusuf; Swearingen, Christopher J
2009 Nov;35(4):851-60, xi, Rheumatic diseases clinics of North America
A method is summarized to improve quality control of the patient history in the medical record, incorporating the patient as a partner to review and correct the information. This method has been implemented at every patient visit to the senior author since 2000, in the infrastructure of usual medical care, using a database. This procedure engenders a more accurate patient history with no effort on the part of the physician, saving time for the physician and improving the quality of the medical record
— id: 105669, year: 2009, vol: 35, page: 851, stat: Journal Article,

Increased lipid levels but unchanged atherogenic index in rheumatoid arthritis patients treated with biologic disease modifying antirheumatic drugs: published experience
Schimmel, E K; Yazici, Y
2009 May-Jun;27(3):446-451, Clinical & experimental rheumatology
BACKGROUND:Cardiovascular disease (CVD) is a major cause of increased mortality in rheumatoid arthritis (RA) patients, and it is recommended to treat risk factors for CVD in RA patients aggressively, including increased lipid levels. However, the effect of biological disease modifying antirheumatic drugs (DMARD) on the lipid profile of RA patients remains under-researched, and what data exist are often contradictory. OBJECTIVES:To review available data published to date on lipid profile changes in RA patients treated with biologic DMARDs.METHODS:We searched the PubMed database without time limits until January 31, 2008 for original clinical trials regarding the effect of biological DMARDs on the lipid profiles of RA patients, tabulating total cholesterol, LDL, HDL and atherogenic index (ratio of total cholesterol to HDL) data for RA patients treated with biologic DMARDs. Percent change values from baseline to end of study were calculated.RESULTS:Eighteen studies fulfilled our inclusion criteria. The total cholesterol levels of patients treated with biological DMARDs was reported to increase in eleven studies (mean change 14.8%). One study reported a decrease (change 4.07%), and six reported no significant change. In HDL levels, nine studies reported increases (mean change 13.1%), two reported decreases (mean change 8.69%) and six reported no significant changes. Five studies reported an increase in LDL levels (mean change 11.2%), no studies reported a decrease, and six studies reported no significant change. The atherogenic index was reported to increase in two studies (mean change 4.27%), decrease in two studies (mean change 7.26%), and not significantly change in nine studies. Only a third of the reviewed articles reported on the LDL/HDL ratio, but of those that did, two reported an increase (mean change 4.55%), one reported a decrease (change 8.03%), and three reported no significant changes.DISCUSSION:Our data suggest increases in lipid levels between baseline and end of study in clinical trials of RA patients treated with biologic DMARDs. However, the clinical implications of this finding with regard to cardiovascular outcomes are not clear in part due to the fact that in most of the studies the atherogenic index was not significantly changed from baseline to end of study. Those studies that do provide data on effects on cholesterol rarely provide information on the complete lipid profile
— id: 100677, year: 2009, vol: 27, page: 446, stat: Journal Article,

Necrotizing vasculitis--a 2009 update
Sharaf, Pamela H; Yazici, Yusuf
2009 ;67(3):303-305, Bulletin of the NYU Hospital for Joint Diseases
Necrotizing vasculitis continues to be a condition where difficult diagnostic and treatment decisions need to be made, with only a few well-done studies as clinical reference and support. New data suggest that both methotrexate and azathioprine may be effective agents for maintaining remission in antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis after remission is achieved with cyclophosphamide-based therapies. In addition, Behcet's syndrome appears to be more common than previously assumed and is likely more common than a combination of ANCA-associated vasculitis (AAV) syndromes
— id: 104901, year: 2009, vol: 67, page: 303, stat: Journal Article,

A significant proportion of patients with RA achieve simplified disease activity index (SDAI)-defined low disease activity or remission with abatacept vs placebo, and SDAI remission is associated with reduced radiographic progression
Smolen J.S.; Aletaha D.; Le Bars M.; Poncet C.; Schiff M.; Kremer J.M.; Yazici Y.
2009 ;60:1691-1691, Arthritis & rheumatism
Purpose: The SDAI composite disease activity index is a stringent measure of remission1, and good correlation between SDAI states and changes in radiographic progression have been reported2. Analyses were performed to assess SDAI disease activity status and to determine the correlation between SDAI status and radiographic progression in patients (pts) with RA and an inadequate response to MTX. Methods: Pts who completed the 1-yr, randomized, double-blind period of the AIM (Abatacept in Inadequate Responders to MTX) trial (abatacept ~10 mg/kg or placebo, plus MTX)³ and had radiographs at baseline and Yr 1 were eligible for analysis (post hoc, as observed). SDAI states were assessed at Mths 3 and 12, defined as High Disease Activity (HDA; >26), Moderate Disease Activity (MDA; >11-26), Low Disease Activity (LDA; >3.3-11) or remission (<=3.3). Changes from baseline to Mth 12 in Genant-modifed Sharp total score (TS) were analysed by SDAI status attained at Mth 3. Results: 366 abatacept and 154 placebo pts were eligible for analysis. Baseline demographics were comparable between treatment groups3. At Mth 3, significantly more abatacept than placebo pts had achieved LDA; at Mth 12, the proportions of abatacept pts in LDA and remission had increased ~twofold and differences between treatment groups were statistically significant for both measures (Figs). The proportion of abatacept pts in HDA was reduced by ~45% from Mth 3 to 12; levels were significantly lower vs placebo at both time points ((Figs). In the radiographic analysis, the smallest change in TS from baseline to Mth 12 was observed in abatacept pts who achieved remission at Mth 3 (change in TS: -0.2 [n=14]); mean changes in TS were 0.63 (72), 1.1 (159) and 1.97 (104) for LDA, MDA and HDA, respectively. For placebo pts mean changes in TS were 0.73 (3), 2.75 (12), 2.26 (50) and 2.9 (81) for remission, LDA, MDA and HDA, respectively. Changes in TS, especially in the remission and LDA groups, were numerically smaller in abatacept vs placebo pts. Conclusion: A significant proportion of abatacept pts achieved LDA or remission vs placebo over 1 yr according to the stringent SDAI criteria. SDAI remission and LDA at Mth 3 were associated with low levels of radiographic progression at Mth 12, in particular with abatacept compared with placebo, suggesting that these states are predictive of a reduction in radiographic progression, as observed with other biologics⁴
— id: 130315, year: 2009, vol: 60, page: 1691, stat: Journal Article,

Disparities in rheumatoid arthritis disease activity according to gross domestic product in 25 countries in the QUEST-RA database
Sokka, T; Kautiainen, H; Pincus, T; Toloza, S; da Rocha Castelar Pinheiro, G; Lazovskis, J; Hetland, M L; Peets, T; Immonen, K; Maillefert, J F; Drosos, A A; Alten, R; Pohl, C; Rojkovich, B; Bresnihan, B; Minnock, P; Cazzato, M; Bombardieri, S; Rexhepi, S; Rexhepi, M; Andersone, D; Stropuviene, S; Huisman, M; Sierakowski, S; Karateev, D; Skakic, V; Naranjo, A; Baecklund, E; Henrohn, D; Gogus, F; Badsha, H; Mofti, A; Taylor, P; McClinton, C; Yazici, Y
2009 Nov;68(11):1666-1672, Annals of rheumatic diseases
OBJECTIVE: To analyze associations between clinical status of patients with rheumatoid arthritis (RA) and the gross domestic product (GDP) of their resident country. METHODS: The Quantitative Standard Monitoring of RA (QUEST-RA) cohort includes clinical and questionnaire data from 6,004 patients who were seen in usual care at 70 rheumatology clinics in 25 countries as of April 2008, including 18 European countries. Demographic variables, clinical characteristics, RA disease activity measures including the Disease Activity Score (DAS28), and treatment related variables were analyzed according to GDP per capita, including 14 'high gpd' countries with GDP per capita >24K USD, and 11 'low gpd' countries with GDP per capita <11K USD. RESULTS: Disease activity DAS28 ranged between 3.1 and 6.0 among the 25 countries, and was associated significantly with GDP [r= -0.78 (95% CI -0.56 to -0.90), r2 = 61%]. Disease activity levels differed substantially between 'high gdp' and 'low gdp' countries at much greater levels than according to whether patients were currently taking or not taking methotrexate, prednisone, and/or biologic agents. CONCLUSIONS: Clinical status of patients with RA was correlated significantly with GDP among 25 mostly European countries according to all disease measures, associated only modestly with current use of anti-rheumatic medications. The burden of arthritis appears substantially greater in 'low gdp' than in 'high gdp' countries. These findings may alert health care professionals and designers of health policy toward improving clinical status of patients with RA in all countries
— id: 102488, year: 2009, vol: 68, page: 1666, stat: Journal Article,

Women, men, and rheumatoid arthritis: analyses of disease activity, disease characteristics, and treatments in the QUEST-RA Study
Sokka, Tuulikki; Toloza, Sergio; Cutolo, Maurizio; Kautiainen, Hannu; Makinen, Heidi; Gogus, Feride; Skakic, Vlado; Badsha, Humeira; Peets, Tonu; Baranauskaite, Asta; Geher, Pal; Ujfalussy, Ilona; Skopouli, Fotini N; Mavrommati, Maria; Alten, Rieke; Pohl, Christof; Sibilia, Jean; Stancati, Andrea; Salaffi, Fausto; Romanowski, Wojciech; Zarowny-Wierzbinska, Danuta; Henrohn, Dan; Bresnihan, Barry; Minnock, Patricia; Knudsen, Lene Surland; Jacobs, Johannes Wg; Calvo-Alen, Jaime; Lazovskis, Juris; Pinheiro, Geraldo da Rocha Castelar; Karateev, Dmitry; Andersone, Daina; Rexhepi, Sylejman; Yazici, Yusuf; Pincus, Theodore
2009 Jan 14;11(1):R7-R7, Arthritis research & therapy
ABSTRACT: INTRODUCTION: Gender as a predictor of outcomes of rheumatoid arthritis (RA) has evoked considerable interest over the decades. Historically, there is no consensus whether RA is worse in females or males. Recent reports suggest that females are less likely than males to achieve remission. Therefore, we aimed to study possible associations of gender and disease activity, disease characteristics, and treatments of RA in a large multinational cross-sectional cohort of patients with RA called Quantitative Standard Monitoring of Patients with RA (QUEST-RA). METHODS: The cohort includes clinical and questionnaire data from patients who were seen in usual care, including 6,004 patients at 70 sites in 25 countries as of April 2008. Gender differences were analyzed for American College of Rheumatology Core Data Set measures of disease activity, DAS28 (disease activity score using 28 joint counts), fatigue, the presence of rheumatoid factor, nodules and erosions, and the current use of prednisone, methotrexate, and biologic agents. RESULTS: Women had poorer scores than men in all Core Data Set measures. The mean values for females and males were swollen joint count-28 (SJC28) of 4.5 versus 3.8, tender joint count-28 of 6.9 versus 5.4, erythrocyte sedimentation rate of 30 versus 26, Health Assessment Questionnaire of 1.1 versus 0.8, visual analog scales for physician global estimate of 3.0 versus 2.5, pain of 4.3 versus 3.6, patient global status of 4.2 versus 3.7, DAS28 of 4.3 versus 3.8, and fatigue of 4.6 versus 3.7 (P < 0.001). However, effect sizes were small-medium and smallest (0.13) for SJC28. Among patients who had no or minimal disease activity (0 to 1) on SJC28, women had statistically significantly higher mean values compared with men in all other disease activity measures (P < 0.001) and met DAS28 remission less often than men. Rheumatoid factor was equally prevalent among genders. Men had nodules more often than women. Women had erosions more often than men, but the statistical significance was marginal. Similar proportions of females and males were taking different therapies. CONCLUSIONS: In this large multinational cohort, RA disease activity measures appear to be worse in women than in men. However, most of the gender differences in RA disease activity may originate from the measures of disease activity rather than from RA disease activity itself
— id: 93844, year: 2009, vol: 11, page: R7, stat: Journal Article,

Patients with early RA treated with abatacept plus MTX have a higher likelihood of increasing or maintaining initial improvements in signs and symptoms and physical function over time than those treated with MTX alone
Yazici Y.; Moniz Reed D.; Covucci A.; Becker J.C.; Westhovens R.
2009 ;60:1688-1688, Arthritis & rheumatism
Purpose: EULAR/ACR recommendations stress the importance of reporting the sustainability of treatment responses in patients (pts) with RA1. Here we assess the likelihood of maintaining/improving initial improvements in the signs/symptoms of RA and physical function with abatacept over 1 year (yr), in MTX-naive pts with early RA and poor prognostic factors. Methods: In the 12-month (mth) double-blind period of AGREE (Abatacept study to Gauge Remission and joint damage progression in MTX-nave pts with Early Erosive RA)², pts with RA <=2 yrs received abatacept (~10 mg/kg) + MTX or MTX alone. In these post-hoc analyses, shifts in ACR response and Health Assessment Questionnaire-Disability Index (HAQ-DI) status from Mth 3 to 12 were evaluated in pts who completed the
— id: 130335, year: 2009, vol: 60, page: 1688, stat: Journal Article,

Behet syndrome (BS) in the US: Clinical characteristics, treatment and ethnic/racial differences in manifestations in 347 patients with BS
Yazici Y.; Schimmel E.; Swearingen C.J.
2009 ;60:649-649, Arthritis & rheumatism
Purpose: Behcet syndrome (BS) is a systemic vasculitis that is common in the old Silk Route but rare in northern Europe and the US. Previous reports have suggested that there may be ethnic and racial differences in disease presentation and possible clustering of manifestations. We started a dedicated Behcet clinic in 2004 and now report on the disease characteristics of the first 347 patients, we believe representing thus far the largest cohort in the US Methods: All patients seen at the center have complete a MDHAQ, and a questionnaire about past medical history, medication use, Behcet specific history, ethnic and demographic information. These data are prospectively collected and updated each visit. About 2/3 of patients live within driving distance of NYC while patients from over 30 states have been seen. Patients were analyzed as the whole cohort and then also separated into to 2 groups: Group A= with ethnic background in northern Europe and North America and/or self declared Caucasians without background around the Mediterranean and/or the Far East; Group B= Patients with an ethnic background in the Mediterranean, Middle East, North Africa, and Far East. These groups were compared for disease manifestations, demographic information and medication use. Results: 347 patients (76% female, mean (SD) disease duration 3.8 (5.4) years, mean (SD) age 53 (13)) of whom 88% fulfilled the International Behcet classification criteria, were analyzed. For the whole cohort most common symptoms were oral ulcers (94%), genital ulcers (76.2%), skin involvement (70.2%), arthritis (54.7%), GI disease (37.9%) and eye disease (27.9%). 15.2% had CNS, 9.7% had vascular/DVT involvement. Less than 10% were positive for pathergy test and 11% had a positive HLA B51. None of the patients were blind. Group A had statistically more significant GI disease (47.5% vs. 27.4%, p<0.001). There were also more females in Group A, compared to Group B (Group A: 85%, Group B:69%, p<0.001). Most commonly used medication was low dose prednisone (69.6%), in most patients as needed for flares, followed by colchicine (50.9%), TNF inhibitors (23.3%) and azathioprine (22.5%). 17.6% were on methotrexate, the only medication with significantly different frequency of use among the two groups (Group A=26.8%, Group B=8.6%, p<0.001). Conclusion: In this cohort of 347 BS patients, largest cohort in the US to the best of our knowledge, some clinical differences were noted between patients with different ethnic backgrounds. There were significantly more female patients in the non-ethnic groups and GI disease was significantly more among these patients also. Eye disease prevalence for both groups was less than reported from other centers and may be less severe as none of the patients were blind. These finding may have implications regarding the pathogenesis and the effect of nature vs nurture on the presentation of BS in different geographic areas
— id: 130320, year: 2009, vol: 60, page: 649, stat: Journal Article,

Patient and physician perception of the infusion process of the biologic agents abatacept, infliximab, and rituximab for the treatment of rheumatoid arthritis
Yazici, Y; McMorris, B J; Darkow, T; Rosenblatt, L C
2009 Nov-Dec;27(6):907-913, Clinical & experimental rheumatology
OBJECTIVES:To assess the process related to each infusible biologic used in rheumatoid arthritis (RA) with regard to patient and physician engagement in the infusion process, ancillary services required, and participant preferences.METHODS:This was a cross-sectional survey of patients with RA and their physicians. Biologic-naive patients with RA starting abatacept, infliximab, or rituximab were included. Both patients and physicians completed detailed questionnaires related to the infusion and satisfaction with the process.RESULTS:A total of 205 patients were enrolled: abatacept (n=102), infliximab (n=74), rituximab (n=29). Patients were primarily female (75%), Caucasian (85%), with a mean age of 58 years. Patients had a mean disease duration of approximately 8 years and had typically failed multiple DMARDs. Rituximab required the most pre-infusion preparation and the longest infusion time. Abatacept was associated with a shorter mean infusion time (42 minutes) than infliximab (131 minutes; p<0.0001) or rituximab (274 minutes; p<0.0001) and required less time away from work/home (p=0.01 and p<0.0001, respectively). Abatacept patients reported significantly less discomfort than rituximab patients (p=0.03), while discomfort was similar between abatacept and infliximab. From the physicians' perspective, compared to infliximab and rituximab abatacept was very easy to administer (57% vs. 27% and 5%, respectively), caused no pain/discomfort (52% vs. 42% and 31%), and had very infrequent infusion reactions (75% vs. 30% and 44%).CONCLUSION:The process involved in infusion administration, as perceived by both the patient and physician, seems to differ across the three infusible biologic agents and may have an impact on the decision-making process regarding which infusible biologic to use
— id: 107279, year: 2009, vol: 27, page: 907, stat: Journal Article,

Safety reporting in randomized clinical trials - a need for improvement
Yazici, Yusuf
2009 ;67(2):209-210, Bulletin of the NYU Hospital for Joint Diseases
The reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking in the publication of trials. Part of the problem is the way safety data are reported in RCTs. Reporting of 'time to event,' use of standardized incidence ratios for comparison to normal population or disease controls, use of 'patient years' when reporting AE, and adequate sample size and power calculations are some of the problems that need to be addressed and improved in RCTs
— id: 101122, year: 2009, vol: 67, page: 209, stat: Journal Article,

Treatment of rheumatoid arthritis: we are getting there
Yazici, Yusuf
2009 Jul 18;374(9685):178-180, Lancet
— id: 101119, year: 2009, vol: 374, page: 178, stat: Journal Article,

Changing patterns of tumor necrosis factor inhibitor use in 9074 patients with rheumatoid arthritis
Yazici, Yusuf; Krasnokutsky, Svetlana; Barnes, Jaime P; Hines, Patricia L; Wang, Jason; Rosenblatt, Lisa
2009 May;36(5):907-913, Journal of rheumatology
OBJECTIVE: Patients with rheumatoid arthritis (RA) commonly switch between tumor necrosis factor (TNF) inhibitors after failing to control disease activity. Much of the clinical data that support switching to a second TNF agent when one agent fails to work has come from small, short-term studies. We utilized a US insurance claims database to determine patterns of use such as dose escalation, time to discontinuation, and switching between TNF inhibitors in patients with RA. METHODS: A retrospective analysis was performed using an insurance claims database in the US from 2000 to 2005. TNF inhibitor use, time to switch, dose escalation, and continuation times were analyzed in patients with RA. RESULTS: Nine thousand seventy-four patients with RA started TNF inhibitors during the period 2000 to 2005. Etanercept was the most commonly used TNF inhibitor; infliximab had the highest duration of continuation, about 50% at 2 years. In addition, infliximab showed higher rates of dose escalation compared to etanercept and adalimumab. For all TNF inhibitors, time to switching decreased from 2000 to 2005. CONCLUSION: TNF inhibitor use patterns changed from 2000 to 2005, with more frequent changes among the different TNF inhibitors and a shorter duration of treatment before the change. Only about 50% of TNF inhibitors are still continued at 2 years, reflecting the difference between randomized clinical trials and real-world experience
— id: 98893, year: 2009, vol: 36, page: 907, stat: Journal Article,

Radiographic measures to assess patients with rheumatoid arthritis: advantages and limitations
Yazici, Yusuf; Sokka, Tuulikki; Pincus, Theodore
2009 Nov;35(4):723-9, vi, Rheumatic diseases clinics of North America
Radiographs present several attractive features for the assessment and monitoring of patients with rheumatoid arthritis (RA). Radiographic erosions are the closest to a pathognomonic sign in RA. Radiographs provide a permanent record of permanent damage. Excellent quantitative scoring systems have been developed by Larsen, Sharp, van der Heijde, Genant, Rau, and others. However, quantitative radiographic scoring is used only in research studies and is not included in usual treatment. Furthermore, magnetic resonance imaging and ultrasonography may be more sensitive than radiography in detecting abnormalities. Moreover, treatment of patients with RA should be initiated before evidence of damage. Reports that biologic therapy is superior to methotrexate in preventing radiographic progression are accurate for groups of patients, although methotrexate and other disease-modifying antirheumatic drugs control inflammation in 70% to 80% of patients and most patients present no radiographic progression with methotrexate. Radiographic findings are also much less significant and functional measures are far more significant in the prediction of severe outcomes of RA, including costs and mortality. Whereas prevention of radiographic progression is certainly desirable, it appears that prevention of functional disability is far more important for successful patient outcomes
— id: 105658, year: 2009, vol: 35, page: 723, stat: Journal Article,

Routine assessment of patient index data (RAPID3), a patient-based measure of disease activity, is associated with work outcomes among patients with early rheumatoid arthritis taking adalimumab (HUMIRA (R))
Bergman, M; Yazici, Y; Roy, S; Ray, S; Cifaldi, M
2008 SEP ;58(9):S458-S458, Arthritis & rheumatism
— id: 88550, year: 2008, vol: 58, page: S458, stat: Journal Article,

Time to score indices to assess clinical status in
Colglazier, CL; Swearingen, C; Kaell, A; Kunath, A; Siegel, E; Bergman, M; Yazici, Y; Pincus, T
2008 SEP ;58(9):S750-S751, Arthritis & rheumatism
— id: 88563, year: 2008, vol: 58, page: S750, stat: Journal Article,

Behcet's syndrome activity score (BSAS): A new disease activity assessment tool, composed of patient-derived measures only, is strongly correlated with the Behcet's disease current activity form (BDCAF)
Forbess, C; Swearingen, C; Yazici, Y
2008 SEP ;58(9):S854-S855, Arthritis & rheumatism
— id: 88574, year: 2008, vol: 58, page: S854, stat: Journal Article,

Erythrocyte sedimentation rate and C-reactive protein levels are poorly correlated with clinical measures of disease activity in rheumatoid arthritis, systemic lupus erythematosus and osteoarthritis patients
Keenan, R T; Swearingen, C J; Yazici, Y
2008 Sep-Oct;26(5):814-819, Clinical & experimental rheumatology
OBJECTIVE:To determine the patterns and correlation of elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels with outcome measures in rheumatoid arthritis (RA), and compare it to systemic lupus erythematosus (SLE) and osteoarthritis (OA) patients.METHODS:Brooklyn Outcomes Arthritis Registry Database (BOARD) was analyzed to determine both first visit and mean values of ESR and CRP, along with disease activity measures in each patient. Data were analyzed with descriptive statistics and correlations.RESULTS:Among all patients half of all (n=377) ESR results were elevated. In RA patients the proportions of having both ESR and CRP elevated, both within normal levels, and only one elevated and the other normal were similar. For all diagnosis, both ESR and CRP have weak positive correlations with disease activity measures measured at first visits. ESR and CRP have a modest positive correlation with each other across all three disease groups.CONCLUSION:In this cohort of RA, SLE and OA patients, ESR and CRP values were modestly correlated with each other and they were weakly correlated with disease activity measures. These data suggest that another look at the role of ESR and CRP as markers of inflammation in RA patients seen in routine care may be in order
— id: 97783, year: 2008, vol: 26, page: 814, stat: Journal Article,

Duration of morning stiffness in the assessment of rheumatoid arthritis activity: A questionable issue
Khan, N; Yazici, Y; Gossec, L; Hansen, T; Muller, R; Tammaru, M; Kallikorm, R; Tsirogianni, A; Sokka, T; Huisman, M; Tlustochowicz, W
2008 SEP ;58(9):S761-S761, Arthritis & rheumatism
— id: 88565, year: 2008, vol: 58, page: S761, stat: Journal Article,

Disease activity score (DAS) and health assessment questionnaire (HAQ) values show similar changes from baseline to endpoint in clinical trials of biological agents in patients with rheumatoid arthritis (RA)
Lee, R; Yazici, Y; Pincus, T
2008 SEP ;58(9):S773-S774, Arthritis & rheumatism
— id: 88569, year: 2008, vol: 58, page: S773, stat: Journal Article,

Behcet's syndrome patients have high levels of functional disability, fatigue and pain as measured by a Multi-dimensional Health Assessment Questionnaire (MDHAQ)
Moses Alder, N; Fisher, M; Yazici, Y
2008 Jul-Aug;26(4 Suppl 50):S110-S113, Clinical & experimental rheumatology
OBJECTIVE: Current tools for assessing Behcet's syndrome (BS) do not include patient-reported outcomes such as functional disability, pain or fatigue. We examined various outcome measures using the multi-dimensional Health Assessment Questionnaire (MDHAQ) and compared them between BS patients with and without arthritis. We also compared the results to those for patients with rheumatoid arthritis (RA), the disease in relation to which the MDHAQ has been most thoroughly studied. METHODS: We conducted a comparative review of BS and early RA patients being followed at the New York University Hospital for Joint Diseases (NYU HJD) and the Behcet's Syndrome Center. All patients completed an MDHAQ at each visit, which included functional disability, pain, morning stiffness, fatigue, and patient and physician global assessments of disease activity. A chart review for BS manifestations and treatments was also carried out. All patient evaluations reported here represent the baseline values at first visit. RESULTS: 129 patients with BS and 116 with early RA were surveyed. BS patients had similar pain levels and physician global assessment of disease activity to the RA patients and higher functional disability, fatigue and patient assessments of global disease activity. Among BS patients, those with arthritis had significantly higher scores for all the outcome measures examined except the physician global assessment of disease activity. CONCLUSION: Using the MDHAQ could reveal previously under-recognized problems in BS, as was observed in this survey of BS patients with arthritis. Such information might be helpful in the management of patients with BS
— id: 92175, year: 2008, vol: 26, page: S110, stat: Journal Article,

An index of only patient-reported outcome measures, routine assessment of patient index data 3 (RAPID3), in two abatacept clinical trials: similar results to disease activity score (DAS28) and other RAPID indices that include physician-reported measures
Pincus, T; Bergman, M J; Yazici, Y; Hines, P; Raghupathi, K; Maclean, R
2008 Mar;47(3):345-349, Rheumatology (Oxford)
OBJECTIVES: To analyse the capacity of routine assessment of patient index data 3 (RAPID3), an index of only the three patient-reported outcome (PRO) measures in the RA Core Data Set-physical function, pain and global status-to distinguish abatacept from control treatments in two clinical trials, and to compare RAPID3 results with the disease activity score 28 (DAS28) and RAPID-based indices that add a tender or swollen joint count and/or physician/assessor global estimate of status. METHODS: Clinical trial data from AIM (Abatacept in Inadequate response to Methotrexate) and ATTAIN [Abatacept Trial in Treatment of Anti-tumor necrosis factor (anti-TNF) INadequate responders] were reanalysed. Mean values were computed at baseline, endpoint and for change between baseline and endpoint for RAPID3, DAS28 and additional RAPID indices to study whether they had greater capacity to distinguish abatacept from control therapy. RAPID4TJC adds to RAPID3 a tender joint count; RAPID4SJC, a swollen joint count; RAPID4MD, a physician/assessor global estimate; and RAPID5 adds both a tender joint count and physician/assessor global estimate. RAPID2 includes only physician/assessor and patient global estimates. RESULTS: All indices indicated significant differences of 19-28% between abatacept and control groups. Results were similar for RAPID3 of only patient measures, compared to DAS28 and other RAPID-based indices. CONCLUSION: A RAPID3 'patient-only' index, without a joint count or any measure from a health professional or laboratory, distinguishes active from control treatments in two abatacept clinical trials, at levels similar to DAS28 and to other RAPID-based indices that add physician-reported measures
— id: 76392, year: 2008, vol: 47, page: 345, stat: Journal Article,

Further evidence of significant associations of routine assessment of patient index data 3 (RAPID3) with disease activity score 28 (DAS28) and clinical disease activity index (CDAI) in patients with rheumatoid arthritis (RA)
Pincus, T; Swearingen, C; Bergman, M; Colglazier, CL; Kaell, A; Kunath, A; Siegel, E; Yazici, Y
2008 SEP ;58(9):S681-S681, Arthritis & rheumatism
— id: 88560, year: 2008, vol: 58, page: S681, stat: Journal Article,

Visual analog scales in formats other than a 10 centimeter horizontal line to assess pain and other clinical data
Pincus, Theodore; Bergman, Martin; Sokka, Tuulikki; Roth, Jill; Swearingen, Christopher; Yazici, Yusuf
2008 Aug;35(8):1550-1558, Journal of rheumatology
OBJECTIVE: To analyze visual analog scales (VAS) for pain and patient global estimate on a Multidimensional Health Assessment Questionnaire (MDHAQ) in formats other than a traditional 10 cm horizontal line, designed to facilitate scoring on MDHAQ in usual clinical care. METHODS: The MDHAQ with VAS for pain and global estimate was completed by each patient at each visit. VAS formats other than a traditional (unnumbered) 10 cm horizontal line based on 21 circles at 0.5 intervals were analyzed. Formats included unnumbered, symbol at the 11th circle, numbers and/or squares (instead of circles) at selected intermittent scores, and numbers at each circle. Analyses were performed to study the time to score MDHAQ with different VAS formats, possible 'clustering' of responses in any format, particularly with intermittent numbers and/or symbols, and test-retest reliability of various formats. RESULTS: The median time to score MDHAQ with a 10 cm line VAS was 15.6 seconds, compared to 7.4 seconds for the 21 numbered circle VAS. No other format was scored in fewer seconds. Clustering was seen for scores of VAS formats with intermittent numbers or symbols, which rendered them unsuitable for use. No clustering was seen for the 21 numbered circle VAS format, for which test-retest agreement was significant, and similar to the 10 cm line VAS format. CONCLUSION: A 21 numbered circle VAS may be a desirable alternative to a 10 cm horizontal line, yielding similar results and requiring less than half the time to score
— id: 90154, year: 2008, vol: 35, page: 1550, stat: Journal Article,

RAPID3 (Routine Assessment of Patient Index Data 3), a Rheumatoid Arthritis Index Without Formal Joint Counts for Routine Care: Proposed Severity Categories Compared to Disease Activity Score and Clinical Disease Activity Index Categories
Pincus, Theodore; Swearingen, Christopher J; Bergman, Martin; Yazici, Yusuf
2008 Nov;35(11):2136-2147, Journal of rheumatology
OBJECTIVE: To compare 4 categories (high, moderate, and low severity, and near-remission) of RAPID3 (Routine Assessment of Patient Index Data 3), an index without formal joint counts, which is scored in < 10 seconds to 4 categories of the Disease Activity Score (DAS28) and Clinical Disease Activity Index (CDAI) in patients with rheumatoid arthritis (RA). METHODS: All patients complete a Multidimensional Health Assessment Questionnaire (MDHAQ) at each visit. A physician/assessor 28-joint count and erythrocyte sedimentation rate (ESR) were completed in 285 patients with RA in usual care by 3 rheumatologists to score DAS28, CDAI, and RAPID3. RAPID3 includes the 3 MDHAQ patient self-report RA Core Data Set measures for physical function, pain, and patient global estimate. Proposed RAPID3 (range 0-10) severity categories of high (> 4), moderate (2.01-4), low (1.01-2), and near-remission (</= 1) were compared to DAS (0-10) activity categories of high (> 5.1), moderate (3.21-5.1), low (2.61-3.2), and remission (</= 2.6), and CDAI (0-76) categories of > 22, 10.1-22.0, 2.9-10.0, and </= 2.8. Additional RAPID scores, which add to RAPID3 a physician/assessor or patient self-report joint count and/or assessor global estimate, were also analyzed. Statistical significance was analyzed using Spearman correlations, cross-tabulations, and kappa statistics. RESULTS: All RAPID scores were correlated significantly with DAS28 and CDAI (rho > 0.65, p < 0.001). Overall, 78%-84% of patients who met DAS28 or CDAI moderate/high activity criteria met similar RAPID severity criteria, and 68%-77% who met DAS28 or CDAI remission/low activity criteria also met similar RAPID criteria. RAPID3 was as informative as other indices. CONCLUSION: RAPID3 provides a feasible, informative quantitative index for busy clinical settings
— id: 90147, year: 2008, vol: 35, page: 2136, stat: Journal Article,

Hotel-based medicine
Pincus, Theodore; Yazici, Yusuf; Bergman, Martin J
2008 Aug;35(8):1487-1488, Journal of rheumatology
— id: 90152, year: 2008, vol: 35, page: 1487, stat: Journal Article,

Are excellent systematic reviews of clinical trials useful for patient care?
Pincus, Theodore; Yazici, Yusuf; Sokka, Tuulikki
2008 Jun;4(6):294-295, Nature clinical practice. Rheumatology
— id: 79417, year: 2008, vol: 4, page: 294, stat: Journal Article,

Physical inactivity in patients with rheumatoid arthritis: data from twenty-one countries in a cross-sectional, international study
Sokka, Tuulikki; Hakkinen, Arja; Kautiainen, Hannu; Maillefert, Jean Francis; Toloza, Sergio; Mork Hansen, Troels; Calvo-Alen, Jaime; Oding, Rolf; Liveborn, Margareth; Huisman, Margriet; Alten, Rieke; Pohl, Christof; Cutolo, Maurizio; Immonen, Kai; Woolf, Anthony; Murphy, Eithne; Sheehy, Claire; Quirke, Edel; Celik, Selda; Yazici, Yusuf; Tlustochowicz, Witold; Kapolka, Danuta; Skakic, Vlado; Rojkovich, Bernadette; Muller, Raili; Stropuviene, Sigita; Andersone, Daina; Drosos, Alexandros A; Lazovskis, Juris; Pincus, Theodore
2008 Jan 15;59(1):42-50, Arthritis & rheumatism
OBJECTIVE: Regular physical activity is associated with decreased morbidity and mortality. Traditionally, patients with rheumatoid arthritis (RA) have been advised to limit physical exercise. We studied the prevalence of physical activity and associations with demographic and disease-related variables in patients with RA from 21 countries. METHODS: The Questionnaires in Standard Monitoring of Patients with Rheumatoid Arthritis (QUEST-RA) is a cross-sectional study that includes a self-report questionnaire and clinical assessment of nonselected consecutive outpatients with RA who are receiving usual clinical care. Frequency of physical exercise (>or=30 minutes with at least some shortness of breath, sweating) is queried with 4 response options: >or=3 times weekly, 1-2 times weekly, 1-2 times monthly, and no exercise. RESULTS: Between January 2005 and April 2007, a total of 5,235 patients from 58 sites in 21 countries were enrolled in QUEST-RA: 79% were women, >90% were white, mean age was 57 years, and mean disease duration was 11.6 years. Only 13.8% of all patients reported physical exercise>or=3 times weekly. The majority of the patients were physically inactive with no regular weekly exercise: >80% in 7 countries, 60-80% in 12 countries, and 45% and 29% in 2 countries, respectively. Physical inactivity was associated with female sex, older age, lower education, obesity, comorbidity, low functional capacity, and higher levels of disease activity, pain, and fatigue. CONCLUSION: In many countries, a low proportion of patients with RA exercise. These data may alert rheumatologists to motivate their patients to increase physical activity levels
— id: 90158, year: 2008, vol: 59, page: 42, stat: Journal Article,

Hispanic early RA patients report worse disease measures at baseline than Caucasian or African American patients however all racial/ethnic groups respond at similar levels to DMARD treatment at 2 years
Yazici, Y; Swearingen, C; Schimmel, E
2008 SEP ;58(9):S681-S682, Arthritis & rheumatism
— id: 88561, year: 2008, vol: 58, page: S681, stat: Journal Article,

Tumor necrosis factor alpha inhibitors, methotrexate or both? An inquiry into the formal evidence for when they are to be used in rheumatoid arthritis
Yazici, Y; Yazici, H
2008 May-Jun;26(3):449-452, Clinical & experimental rheumatology
OBJECTIVE: The relative high cost and potential side effects mandate careful scrutiny as to when tumor necrosis factor alpha (TNF) inhibitors should be used in everyday practice. We surveyed how TNF inhibitors performed in randomized controlled trials when compared to methotrexate in methotrexate naive rheumatoid arthritis patients. METHODS: We identified all randomized controlled trials with TNF inhibitors and methotrexate. We surveyed A-whether the patients enrolled were methotrexate naive or not; B-efficacy outcomes and C-radiographic outcomes. RESULTS: Four studies that had been reported to be conducted among metho-trexate naive patients were identified. TEMPO trial was not done entirely in methotrexate naive patients, contrary to what has been reported by its authors. Among these studies the methotrexate naive arms did as well as the TNF inhibitor alone. The combination was better than either drug alone. Among the 6 studies in which the methotrexate failure patients had been enrolled, the TNF inhibitors always performed better when analyzed head to head with the methotrexate alone arms. CONCLUSIONS: Available data indicate that TNF inhibitors are superior to solo methotrexate use only in the setting of combination treatment
— id: 93324, year: 2008, vol: 26, page: 449, stat: Journal Article,

Some concerns about adverse event reporting in randomized clinical trials
Yazici, Yusuf
2008 ;66(2):143-145, Bulletin of the NYU Hospital for Joint Diseases
Reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking and with limited application in the real world, as RCTs are of short duration, include small numbers of patients, and are selective for subjects lacking in comorbid conditions. It is not surprising that new and unexpected safety concerns emerge with any new drug after it has been launched and used by many more patients. Part of the problem is inherent to the way safety data are reported in RCTs. This article focuses on some of the shortcomings of AE reporting in RCTs, especially those involving tumor necrosis factor (TNF) inhibitors. Discussion focuses on reporting of 'time-to-event' issues, use of standardized incidence ratios for comparison to normal population or disease controls, use of 'patient-years' when reporting AEs, and the problem of adequate sample size and power calculations that are lacking in safety outcome data trials
— id: 93320, year: 2008, vol: 66, page: 143, stat: Journal Article,

Systemic vasculitis treatment and monitoring update, 2008
Yazici, Yusuf
2008 ;66(3):228-230, Bulletin of the NYU Hospital for Joint Diseases
Vasculitic syndromes are among the most complicated diseases for primary care physicians and rheumatologists to diagnose and treat. There are a myriad of symptoms that can be mimicked by other conditions, and choice of medications can be complex. Some agents are toxic and determining which to prescribe and for how long can be a multifaceted, complex decision process. Developing new treatments and new ways of using already available therapies, while minimizing potential side effects, are of paramount importance. This review will focus on recently published data that could have an impact on the way we treat systemic vasculitis patients
— id: 91486, year: 2008, vol: 66, page: 228, stat: Journal Article,

Time to score quantitative rheumatoid arthritis measures: 28-Joint Count, Disease Activity Score, Health Assessment Questionnaire (HAQ), Multidimensional HAQ (MDHAQ), and Routine Assessment of Patient Index Data (RAPID) scores
Yazici, Yusuf; Bergman, Martin; Pincus, Theodore
2008 Apr;35(4):603-609, Journal of rheumatology
OBJECTIVE: To analyze the time required to score different measures used to assess patients with rheumatoid arthritis (RA), as a guide to feasibility in standard care. The measures studied were a 28-Joint Count, Disease Activity Score (DAS), Health Assessment Questionnaire (HAQ), Multidimensional HAQ (MDHAQ), and various Routine Assessment of Patient Index Data (RAPID) scores derived from the MDHAQ. METHODS: Three rheumatologists at 3 sites performed and timed 28-joint counts in 20 different patients at each site. Each rheumatologist scored and timed identical data in 5 groups of 10 from the same 50 patients seen in standard clinical care, including 50 DAS28 indices using the DAS Website, 50 identical HAQ, and 50 identical MDHAQ from the same patients. The MDHAQ includes 10 activities self-assessed for physical function, 21 circle visual analog scales (VAS) (rather than 10 cm lines), and scoring templates on the questionnaire for physical function, patient self-report joint count and RAPID composite scores. RAPID3 includes the 3 Core Data Set measures, RAPID4 adds the self-report joint count to RAPID3, and RAPID5 adds a physician global estimate to RAPID4. RESULTS: The median number of seconds to complete a 28-joint count was 90, compared to 41.9 s for a HAQ, 9.6 s for an MDHAQ RAPID3, and 19.4 s for RAPID5. CONCLUSION: MDHAQ RAPID3 scores can be calculated in considerably less time than other RA measures, using scoring templates on the MDHAQ, to provide informative, feasible, quantitative measures for standard rheumatology clinical care
— id: 80283, year: 2008, vol: 35, page: 603, stat: Journal Article,

Utilization of biologic agents in rheumatoid arthritis in the United States: analysis of prescribing patterns in 16,752 newly diagnosed patients and patients new to biologic therapy
Yazici, Yusuf; Shi, Nianwen; John, Ani
2008 ;66(2):77-85, Bulletin of the NYU Hospital for Joint Diseases
BACKGROUND: Treatment of rheumatoid arthritis (RA) has shifted toward earlier and more aggressive therapy with tra- ditional disease-modifying antirheumatic drugs (DMARDs) and biologics. However, the extent to which these agents are used in current clinical practice in the United States (U.S.) has not been systematically evaluated. MATERIALS AND METHODS: This analysis of a large claims database assessed patterns of use of biologics within clinical practice in a broad U.S. population with RA. We identifed two cohorts of adults with RA using Thomson Healthcare MarketScan Research databases. Patients newly diagnosed with RA between 1999 and 2004 with 12 months or more of continuous enrollment prior to diagnosis and with 24 months or more post-diagnosis were included in one cohort. The second cohort included RA patients who appeared to be newly treated with biologic therapy and had continu- ous enrollment for 12 months or more prior to frst use of a biologic agent and 18 months or more following initial treatment. A total of 16,752 patients, newly diagnosed with RA, and 8218, new to biologics therapy, were included. RESULTS: Utilization of biologics increased from 3% of patients in 1999 to 26% in 2006. Patients initiated biolog- ics both as monotherapy (30%) and in combination with methotrexate (36%). Regimen modifcations were frequent, with a large percentage of patients requiring addition or subtraction of methotrexate. CONCLUSIONS: The use of biologics to treat RA is increas- ing, either as monotherapy or in combination with another DMARD. Modifcations to drug regimens are frequent and episodes are often of comparatively short duration
— id: 93313, year: 2008, vol: 66, page: 77, stat: Journal Article,

Time to score various rheumatoid arthritis (RA) assessment measures as a guide to feasibility in standard care
Bergman, MJ; Yazici, Y; Pincus, T
2007 JUL ;66(1):270-271, Annals of rheumatic diseases
— id: 87137, year: 2007, vol: 66, page: 270, stat: Journal Article,

Aspirin for primary thrombosis prevention in the antiphospholipid syndrome: a randomized, double-blind, placebo-controlled trial in asymptomatic antiphospholipid antibody-positive individuals
Erkan, Doruk; Harrison, Melanie J; Levy, Roger; Peterson, Margaret; Petri, Michelle; Sammaritano, Lisa; Unalp-Arida, Aynur; Vilela, Veronica; Yazici, Yusuf; Lockshin, Michael D
2007 Jul;56(7):2382-2391, Arthritis & rheumatism
OBJECTIVE: To determine the efficacy of a daily dose of 81 mg aspirin in primary thrombosis prevention in asymptomatic, persistently antiphospholipid antibody (aPL)-positive individuals (those with positive aPL but no vascular and/or pregnancy events). METHODS: The Antiphospholipid Antibody Acetylsalicylic Acid (APLASA) study was a multicenter, randomized, double-blind, placebo-controlled clinical trial in which asymptomatic, persistently aPL-positive individuals were randomized to receive a daily dose of 81 mg of aspirin or placebo. In a separate observational and parallel study, asymptomatic, persistently aPL-positive individuals who were taking aspirin or declined randomization were followed up prospectively. RESULTS: In the APLASA study, 98 individuals were randomized to receive aspirin or placebo (mean +/- SD followup period 2.30 +/- 0.95 years), of whom 48 received aspirin and 50 received placebo. In the observational study, 74 nonrandomized individuals were followed up prospectively (mean +/- SD followup period 2.46 +/- 0.76 years); 61 received aspirin and 13 did not. In the APLASA study, the acute thrombosis incidence rates were 2.75 per 100 patient-years for aspirin-treated subjects and 0 per 100 patient-years for the placebo-treated subjects (hazard ratio 1.04, 95% confidence interval 0.69-1.56) (P = 0.83). Similarly, in the observational study, the acute thrombosis incidence rates were 2.70 per 100 patient-years for aspirin-treated subjects and 0 per 100 patient-years for those not treated with aspirin. All but 1 patient with thrombosis in either study had concomitant thrombosis risk factors and/or systemic autoimmune disease at the time of thrombosis. CONCLUSION: Our results suggest that asymptomatic, persistently aPL-positive individuals do not benefit from low-dose aspirin for primary thrombosis prophylaxis, have a low overall annual incidence rate of acute thrombosis, and develop vascular events when additional thrombosis risk factors are present
— id: 94082, year: 2007, vol: 56, page: 2382, stat: Journal Article,

Remission at the conclusion of the aim and attain abatacept clinical trials: Similar results according to disease activity score (DAS28) and an index of only patient measures, without joint counts, routine assessment of patient index data (RAPID3)
Pincus, T; Bergman, MJ; Yazici, Y; Hines, P; Macleans, R
2007 JUL ;66(1):436-436, Annals of rheumatic diseases
— id: 87144, year: 2007, vol: 66, page: 436, stat: Journal Article,

Indices based on patient reported outcomes for use in standard clinical care, rheumatoid arthritis patient index data (RAPID): Performance in two abatacept clinical trials of 4 rapid indices of 2-5 core data set measures
Pincus, T; Bergman, MJ; Yazici, Y; Raghupathi, K; Hines, P; Macleans, R
2007 JUL ;66(1):271-272, Annals of rheumatic diseases
— id: 87139, year: 2007, vol: 66, page: 271, stat: Journal Article,

Composite index of physical function, pain, patient global and joint count, rapid4 (routine assessment of patient index data): Virtually identical results with a patient self-report or physician/assessor joint count or no joint count in rapids
Pincus, T; Bergman, MJ; Yazici, Y; Swearingen, C
2007 JUL ;66(1):270-270, Annals of rheumatic diseases
— id: 87136, year: 2007, vol: 66, page: 270, stat: Journal Article,

Quantitative measurement of patient status in the regular care of patients with rheumatic diseases over 25 years as a continuous quality improvement activity, rather than traditional research
Pincus, T; Maclean, R; Yazici, Y; Harrington, J T
2007 Nov-Dec;25(6 Suppl 47):69-81, Clinical & experimental rheumatology
Patient assessment in rheumatology is characterized by an important paradox: many extensively-characterized quantitative measures and indices have been developed for rheumatoid arthritis (RA), psoriatic arthritis, systemic lupus erythematosus (SLE), ankylosing spondylitis, vasculitis, osteoarthritis, fibromyalgia, and other rheumatic diseases. However, most regular rheumatology care is guided largely by qualitative clinical impressions, without such measures or indices or any quantitative data other than laboratory tests to assess patient status and/or quality of care. This paradox may be explained in part by regarding the development of measures primarily as clinical research activities, while viewing the application of measurements in regular clinical care as continuous quality improvement (CQI) activities. The development of measures has emphasized validity and reliability, but generally ignored feasibility and acceptability to patients and health professionals, both of which are needed for application in regular clinical care. A summary of the application of clinical measurement in patients with RA over 25 years between 1982 and 2007 at a weekly academic rheumatology clinic conducted by the senior author is presented as 20 often contemporaneous CQI cycles. These cycles include development of a user-friendly modified health assessment questionnaire (MHAQ); assessment of psychological status; monitoring of mortality outcomes; comparisons of joint counts, radiographic scores, and laboratory tests to the MHAQ; a 28-joint count; prospective study of the MHAQ to predict mortality when joint counts, radiographic scores, and laboratory tests are available; development of a multidimensional HAQ (MDHAQ) with complex activities; a fatigue scale; a self-report joint count; scoring templates; a computerized data management system; flow sheets to monitor MDHAQ status; visual analog scales as 21 circles rather than 10 cm lines; composite RAPID3 (rheumatology assessment patient index data) scores for 3 patient measures; and defining RAPID categories for high, moderate and low severity, and near remission. The latter cycles remain under study as ongoing CQI activities
— id: 75485, year: 2007, vol: 25, page: 69, stat: Journal Article,

An index without formal joint counts, routine assessment of patient index data (RAPID3), to help guide tight control of RA in standard care: Most patients who meet das or CDAI remission or high activity criteria meet identical preliminary rapid criteria
Pincus, T; Yazici, Y; Bergman, MJ; Swearingen, C
2007 JUL ;66(1):271-271, Annals of rheumatic diseases
— id: 87138, year: 2007, vol: 66, page: 271, stat: Journal Article,

Comparisons of a self-report rheumatoid arthritis disease activity index (RADAI) joint count to American College of rheumatology (ACR) core data set measures for rheumatoid arthritis (RA)
Pincus, T; Yazici, Y; Bergman, MJ; Swearingen, C
2007 JUL ;66(1):335-336, Annals of rheumatic diseases
— id: 87141, year: 2007, vol: 66, page: 335, stat: Journal Article,

N-of-1 trial of low-dose methotrexate and/or prednisolone in lieu of anti-CCP, MRI, or ultrasound, as first option in suspected rheumatoid arthritis?
Pincus, Theodore; Huizinga, Tom W J; Yazici, Yusuf
2007 Feb;34(2):250-252, Journal of rheumatology
— id: 90166, year: 2007, vol: 34, page: 250, stat: Journal Article,

Quantitative assessment of musculoskeletal conditions in standard clinical care
Pincus, Theodore; Yazici, Yusuf
2007 Aug;21(4):597-599, Bailliere's best practice & research. Clinical rheumatology
— id: 73933, year: 2007, vol: 21, page: 597, stat: Journal Article,

A practical guide to scoring a Multi-Dimensional Health Assessment Questionnaire (MDHAQ) and Routine Assessment of Patient Index Data (RAPID) scores in 10-20seconds for use in standard clinical care, without rulers, calculators, websites or computers
Pincus, Theodore; Yazici, Yusuf; Bergman, Martin
2007 Aug;21(4):755-787, Bailliere's best practice & research. Clinical rheumatology
The American College of Rheumatology Core Data Set for rheumatoid arthritis (RA) includes 3 measures which are found on a patient self-report questionnaire, physical function, pain, and patient estimate of global status. These measures are included in all clinical trials, but not assessed at most encounters in standard rheumatology care. Rheumatologists may have experience with lengthy research questionnaires in clinical trials and other clinical research, which (appropriately) are regarded as relatively cumbersome research tools and do not contribute to clinical care. A format of a questionnaire known as the multidimensional health assessment questionnaire (MDHAQ) has been developed for standard rheumatology care to contribute to rheumatology clinical care in daily practice. The 3 scores for physical function, pain, and global status can be 'eyeballed' in a second or two and formally scored into a composite index known as rheumatology assessment patient index data (RAPID) in about 10 seconds. This chapter provides a brief tutorial designed to instruct rheumatologists and their staffs regarding how to use and score the MDHAQ and RAPID in standard clinical care
— id: 73934, year: 2007, vol: 21, page: 755, stat: Journal Article,

A proposed continuous quality improvement approach to assessment and management of patients with rheumatoid arthritis without formal joint counts, based on quantitative routine assessment of patient index data (RAPID) scores on a multidimensional health assessment questionnaire (MDHAQ)
Pincus, Theodore; Yazici, Yusuf; Bergman, Martin; Maclean, Ross; Harrington, Timothy
2007 Aug;21(4):789-804, Bailliere's best practice & research. Clinical rheumatology
A continuous quality improvement approach is proposed for the assessment and management of patients with rheumatoid arthritis (RA) based on scores on a one-page patient self-report multidimensional health assessment questionnaire (MDHAQ), without formal joint counts. The approach includes five simple steps before the patient is seen by the physician: (1) an MDHAQ is completed by every patient at every visit; (2) scores are calculated for patient function, pain, and global estimate, with options for a self-report joint count and other scales; (3) scores are entered on flow sheets with data from prior visits, which might also include laboratory and medication information; (4) scores are compiled into an index termed Routine Assessment of Patient Index Data (RAPID), analogous to a Disease Activity Score (DAS); (5) RAPID scores are classified to guide treatment decisions. RAPID 3 includes the three patient-reported outcome (PRO) measures in the RA Core Data Set - physical function, pain, and global estimate. RAPID 4 adds a self-report joint count, and RAPID 5, a physician global estimate. RAPID 3 can be calculated in about 10 seconds, RAPID 4 in about 19 seconds, and RAPID 5 in about 20 seconds. RAPID 3, RAPID 4, and RAPID 5 give similar results to distinguish active from control treatments in RA clinical trials, at levels similar to American College of Rheumatology or DAS improvement criteria, and are all correlated significantly with DAS28 (rho=0.62-0.64, P<0.001). A proposed classification of RAPID scores, analogous to four DAS28 categories, includes: 'near remission' (0-1), 'low severity' (1.01-2), 'moderate severity' (2.01-4), and 'high severity' (>4). RAPID scoring is feasible in standard clinical care to support continuous quality improvement
— id: 74682, year: 2007, vol: 21, page: 789, stat: Journal Article,

Quantitative measures of rheumatic diseases for clinical research versus standard clinical care: differences, advantages and limitations
Pincus, Theodore; Yazici, Yusuf; Sokka, Tuulikki
2007 Aug;21(4):601-628, Bailliere's best practice & research. Clinical rheumatology
No single measure can serve as a 'gold standard' for the diagnosis, prognosis, and monitoring of patients with rheumatic diseases. Therefore, pooled indices of several measures have been developed for patient assessment. Quantitative measures and indices in rheumatology have been used primarily in clinical trials and other clinical research, but not in standard clinical care. Indeed, most standard rheumatology care is conducted without quantitative data other than laboratory tests, which often are uninformative. Some measures used in research have been adapted for standard care. The classical 66/68-joint count with graded scoring for swelling, tenderness, pain on motion, limited motion, and deformity has been shortened for clinical care to a 28-joint count, scored only as 'Yes' or 'No' for swelling or tenderness. Patient questionnaires designed for clinical research can be lengthy, with complex scoring, so that information is not available to help guide clinical decisions. By contrast, patient questionnaires designed for standard care, such as a simple one-page, multi-dimensional health assessment questionnaire (MDHAQ), are short, save time, are easily scored, and are useful in all rheumatic diseases to monitor patient status at each visit and document changes over long periods. More attention to measures for use in standard care could improve care and outcomes for patients with rheumatic diseases
— id: 73871, year: 2007, vol: 21, page: 601, stat: Journal Article,

Interleukin-6 inhibition--tolerability profile and clinical implications
Strand, Vibeke; Yazici, Yusuf
2007 ;65 Suppl 1:S21-S24, Bulletin of the NYU Hospital for Joint Diseases
Tocilizumab, humanized monoclonal antibody to sIL-6R, is a promising new agent for the treatment of rheumatoid arthritis. Safety data from randomized controlled trials (RCT) to date have been overall reassuring with no evidence of increased opportunistic infections or malignancies, and some signals for elevated liver function tests and changed lipid profiles. The true implications of these signals in RCTs must be addressed in larger numbers of RA patients with longer term exposure before firm conclusions are reached
— id: 94081, year: 2007, vol: 65 Suppl 1, page: S21, stat: Journal Article,

Monitoring outcomes of arthritis and longitudinal data collection using patient questionnaires in routine care
Yazici, Y
2007 NOV ;18(2):95-100, Eklem hastaliklan ve cerrahisi = Joint diseases & related surgery
At the present time, clinical decisions in routine rheumatology practice generally are based on qualitative impressions, rather than on quantitative data, which might lead to improved information for clinical decisions. Patient questionnaires are the quantitative tools whereby rheumatologists have to monitor their patients' health status and response to therapy. The health assessment questionnaire (HAQ) and its derivatives have been shown to be the best predictors of functional and work disability, costs, joint replacement surgery, and mortality; they are as good as and usually better predictors than joint counts, radiographs, and laboratory tests. Yet, patient questionnaires, which can be used in all rheumatic diseases including osteoarthritis, systemic lupus erythematosus, fibromyalgia, sclerodenna, and ankylosing spondylitis, are not included in routine care by most rheumatologists. Every encounter of a patient with a rheumatologist provides an opportunity to collect data. Data that are feasible to collect in clinical care provide the only way to assess quantitatively how our patients are doing. If data are not collected and recorded, an opportunity is lost forever. Rheumatologists would find it valuable to adapt questionnaires to the care they provide for all their patients, to document and improve the care they provide, and add quantitative data to standard clinical care
— id: 76793, year: 2007, vol: 18, page: 95, stat: Journal Article,

Most rheumatoid arthritis patients seen in the "real world" do not qualify for clinical trials for the treatment of rheumatoid arthritis
Yazici, Y; Kulman, I
2007 NOV ;18(1):1-6, Eklem hastaliklan ve cerrahisi = Joint diseases & related surgery
Objectives: We analyzed rheumatoid arthritis (RA) patients seen in a cohort from Brooklyn, NY over the last three years to determine what percentage of patients would fulfill common inclusion criteria for RA clinical trials at any time during their care. Patients and Methods: One hundred and twenty-three consecutive patients with RA, seen between April 2001 and December 2003 by a single rheumatologist, were included. Patients were analyzed according to whether they met four common inclusion criteria in most recent RA trials, and according to the inclusion criteria for the recent anti-tumor necrosis factor alpha (anti-TNF alpha) trial involving etanercept and methotrexate in early RA (ERA trial) and the STAR (Safety Trial of Adalimumab in Rheumatoid arthritis) trial. All visits were analyzed to identify any visit where patients fulfilled the inclusion criteria. Results: When the most common inclusion criteria for RA clinical trials were applied, 3/146 (2.1%) visits and two of 72 (2.8%) patients fulfilled these criteria. The inclusion criteria for the ERA and STAR trials were met in 4/123 (3.3%) and 17/123 (13.8%) patients, respectively. Conclusion: A large majority of RA patients seen in this cohort would not have qualified for the most common RA clinical trials and the recent anti-TNFa. trials. It is timely to consider new inclusion criteria for RA clinical trials to reflect the current characteristics of most RA patients. This would increase the applicability of the results of these important and usually very expensive studies and therapies
— id: 76786, year: 2007, vol: 18, page: 1, stat: Journal Article,

Methodological concerns in tumor necrosis factor (TNF) inhibitor trials in rheumatoid arthritis (RA), psoriatic arthritis (PSA) and ankylosing spondylitis (AS): power calculations and 1 versus 2-tailed statistical tests
Yazici, Y; Moses, N; Yazici, H
2007 JUL ;66(1):277-278, Annals of rheumatic diseases
— id: 87140, year: 2007, vol: 66, page: 277, stat: Journal Article,

Number needed to treat (NNT) and number needed to harm (NNH): Applying results of randomized clinical trials (RCT) to routine clinical care
Yazici, Y; Moses, N; Yazici, H
2007 JUL ;66(1):342-342, Annals of rheumatic diseases
— id: 87142, year: 2007, vol: 66, page: 342, stat: Journal Article,

A survey of inclusion of the time element when reporting adverse effects in randomized controlled trials of cyclooxygenase-2 and tumor necrosis factor alpha inhibitors
Yazici, Y; Yazici, H
2007 Jan;66(1):124-127, Annals of rheumatic diseases
BACKGROUND: We surveyed the adequacy of reporting the time element in adverse effects in randomized clinical trial articles of cyclooxygenase-2 and tumor necrosis factor alpha antagonists. METHODS: A search in prominent rheumatology and general/internal medicine journals for all randomized controlled trials published about cyclooxygenase-2 and tumor necrosis factor alpha inhibitor use in rheumatologic diseases up to November 2005 was conducted. Reporting of time to the occurrence of the adverse effects, the use of patient - years as the time frame of the reported adverse effects and the utilization of annual standard incidence ratios based on SEER (Surveillance, Epidemiology, and End- RESULTS: program when reporting neoplasms as potential adverse effects of tumor necrosis factor alpha antagonists were specifically tabulated. Results: Only 23/70 (33%) of all articles gave the specific time of onset of an adverse effect. Nine studies used patient - years in reporting the adverse effects and 6 studies used annual standard incidence ratios, using SEER, as the comparator. CONCLUSION: In reporting of adverse effects in randomized clinical trials, a particularly neglected issue is the reporting of the time dimension of adverse effects
— id: 69320, year: 2007, vol: 66, page: 124, stat: Journal Article,

Comment on 'Drug-related pulmonary problems in patients with rheumatoid arthritis'
Yazici, Y; Yazici, H
2007 FEB ;46(2):371-372, Rheumatology (Oxford)
— id: 70613, year: 2007, vol: 46, page: 371, stat: Journal Article,

Databases in routine care: possible and necessary
Yazici, Yusuf
2007 ;65(2):127-131, Bulletin of the NYU Hospital for Joint Diseases
Patient questionnaires are valuable quantitative tools used by rheumatologists to monitor a patient's health status and response to therapy. The health assessment questionnaire (HAQ) and its derivatives have been shown to be the most significant predictors of functional and work disability, costs, joint replacement surgery, and mortality and, generally, at higher levels of significance than joint counts, radiographs, and laboratory tests. Yet, patient questionnaires, which can be used in all rheumatic diseases, are not included in routine care by most rheumatologists. Data that are feasible to collect during clinical care provide the optimal approach to quantitatively assess how patients are doing
— id: 73805, year: 2007, vol: 65, page: 127, stat: Journal Article,

Monitoring outcomes of arthritis and longitudinal data collection in routine care using a patient questionnaire that incorporates a clinical note on one piece of paper
Yazici, Yusuf
2007 Aug;21(4):629-636, Bailliere's best practice & research. Clinical rheumatology
Patient questionnaires are the quantitative tools available to rheumatologists to monitor their patients' health status and responses to therapy. The Health Assessment Questionnaire (HAQ) and its derivatives have been shown to be the most significant predictors of functional and work disability, costs, joint replacement surgery, and mortality; generally at higher levels of significance than joint counts, radiographs, and laboratory tests. Every encounter of a patient with a rheumatologist provides an opportunity to collect data. Yet patient questionnaires, which can be used in all rheumatic diseases, including osteoarthritis, systemic lupus erythematosus, fibromyalgia, scleroderma, and ankylosing spondylitis, are not included in routine care by most rheumatologists. Questionnaires can be adapted to include a simple subjective-objective-assessment-plan (SOAP) clinical encounter note that helps with data entry and also provides all the necessary information for clinical decision making in one sheet of paper. Data that are feasible to collect in clinical care provide the optimal approach to assessing quantitatively how patients are doing. If data are not collected and recorded, that opportunity, on that day, is lost forever. Rheumatologists would find it valuable to adapt questionnaires to the care they provide for all their patients, to document and improve the care they provide, and add quantitative data to standard clinical care
— id: 73936, year: 2007, vol: 21, page: 629, stat: Journal Article,

Monitoring response to treatment in rheumatoid arthritis--which tool is best suited for routine "real world" care?
Yazici, Yusuf
2007 ;65 Suppl 1:S25-S28, Bulletin of the NYU Hospital for Joint Diseases
Rheumatoid arthritis treatment is a fast changing and advancing area. Current drugs are now better utilized and new medications continue to be developed. The main challenge is to identify which patients are responding to treatment and to objectively quantify their response or nonresponse. There is a need for more rheumatologists to pursue use of an objective assessment tool in routine clinical care. Therefore, knowledge of the various tools available to rheumatologists in clinical trials and routine care and their practical differences is important to progress in patient evaluation and management. The tool that is easiest for both the patient and the physician to use and that still provides important treatment response and prognostic information has the best chance to be consistently and successfully applied by busy clinicians
— id: 74667, year: 2007, vol: 65 Suppl 1, page: S25, stat: Journal Article,

Vasculitis update, 2007
Yazici, Yusuf
2007 ;65(3):212-214, Bulletin of the NYU Hospital for Joint Diseases
Vasculitic syndromes are among the most complicated diseases to treat and manage. New medications and new ways of using old medications have provided us with new therapies to treat our patients. This review focuses on recent date that may have an impact on the way vasculitis is treated
— id: 75662, year: 2007, vol: 65, page: 212, stat: Journal Article,

Rheumatoid arthritis treatment and monitoring of outcomes-where we are in 2007?
Yazici, Yusuf; Abramson, Steven B
2007 ;65(4):300-305, Bulletin of the NYU Hospital for Joint Diseases
Rheumatoid arthritis (RA) treatment has witnessed major advances over the last 10 to 20 years. Methotrexate has emerged as the cornerstone of treatment with new biologic agents being used in addition in severe and resistant patients. New drugs being developed with novel modes of action are promising to expand treatment options and help provide better disease control for RA patients. In addition to medications, equally important is aggressive disease activity monitoring using one of the composite scores available in order to match treatments to disease activity. Disease activity score (DAS), DAS28 (with a 28 joint count), clinical disease activity index (CDAI), simplified disease activity index (SDAI), and routine assessment of patient index data (RAPID) are valuable tools and should be used in routine care to achieve disease control
— id: 76149, year: 2007, vol: 65, page: 300, stat: Journal Article,

Differences in clinical status measures in different ethnic/racial groups with early rheumatoid arthritis: implications for interpretation of clinical trial data
Yazici, Yusuf; Kautiainen, Hannu; Sokka, Tuulikki
2007 Feb;34(2):311-315, Journal of rheumatology
OBJECTIVE: Studies have documented differences in health status, disease prevalence, treatment outcomes, and healthcare utilization among different ethnic groups. We compared patients with early rheumatoid arthritis (RA) of different ethnic/racial groups according to disease activity measures, to identify possible differences in patterns of severity of clinical status. METHODS: An early RA treatment evaluation registry (ERATER) with more than 500 patients with less than 3 years of RA was established; 118 ERATER patients are followed in Brooklyn, NY, USA. At each visit, all patients complete a multidimensional Health Assessment Questionnaire (MDHAQ), including functional status, pain, fatigue, global assessment on a 10 cm visual analog scale, psychological distress, and duration of morning stiffness. Clinical evaluation includes tender and swollen joint counts and erythrocyte sedimentation rate (ESR). Baseline measures were collected before patients started any treatments. Clinical status measures in 3 ethnic/racial groups were compared. RESULTS: Hispanic patients with RA scored worst in all self-report measures compared to Caucasians and African Americans, with statistically significant differences in MHAQ functional score, psychological distress, and morning stiffness. The groups were not statistically significantly different in joint counts, ESR, or physician global assessment. CONCLUSION: Our findings indicate differences between ethnic/racial groups in patient derived measures in patients with early RA at presentation. Cultural differences and possible ethnic influences on disease activity measures in clinical trials and clinical care may be important in interpreting differences in prognosis and outcomes of patients with RA.
— id: 73012, year: 2007, vol: 34, page: 311, stat: Journal Article,

Prospects for disease modification in osteoarthritis
Abramson, Steven B; Attur, Mukundan; Yazici, Yusuf
2006 Jun;2(6):304-312, Nature clinical practice. Rheumatology
Osteoarthritis (OA) can be a progressive, disabling disease, leading to diminished quality of life, and, for over 500,000 individuals annually in the US, total joint replacement. The etiology of OA will vary among individuals, with potential roles for systemic factors (such as genetics and obesity) as well as for local biomechanical factors (such as muscle weakness, joint laxity and traumatic injury). Joint deterioration occurs over extended periods of time, and the diverse molecular mechanisms that mediate pathogenic events of early, mid and late disease are not yet fully understood. The success of biologic therapies in the treatment of rheumatoid arthritis has demonstrated that the blockade of a single dominant cytokine or regulatory molecule can prevent cartilage destruction in a complex disease, and has raised expectations that mechanism-based treatments could also be developed for patients with OA. In this review, we will address the biological mechanisms that mediate structural damage in OA and examine current targets that are candidates for disease modification. The challenges to drug development and the obstacles to disease modification strategies will also be addressed
— id: 67863, year: 2006, vol: 2, page: 304, stat: Journal Article,

Biologics in development for rheumatoid arthritis: relevance to osteoarthritis
Abramson, Steven B; Yazici, Yusuf
2006 May 20;58(2):212-225, Advanced drug delivery reviews
The osteoarthritis disease process affects not only the cartilage but also the entire joint structure, including the synovium, bone and periarticular muscles. Characteristically, abnormal biomechanical forces result in an imbalance between chondrocyte anabolic and catabolic pathways, which ultimately leads to progressive joint destruction. Within cartilage and synovium, pro-inflammatory cytokines, particularly IL-1b and TNF-a, auto-catalytically stimulate their own production and induce chondrocytes to produce additional catabolic mediators, including proteases, chemokines, nitric oxide, and prostaglandins. The success of targeted biological therapy in rheumatoid arthritis has taught that the blockade of a single dominant cytokine can lead to remarkable clinical benefit, even in complex disease. The effectiveness of biologicals in inflammatory arthritides as disease modifying agents has increased the likelihood that similar strategies can be developed to target specific molecular mechanisms in osteoarthritis (OA). However, since the clinical development program for disease-modifying OA drugs (DMOADs) is complicated by the slow progression of disease in many patients, the introduction of DMOADs will be greatly enhanced by advances in imaging and biomarkers that serve as validated surrogate endpoints for meaningful clinical outcomes
— id: 68770, year: 2006, vol: 58, page: 212, stat: Journal Article,

Decline of NSAID gastroprotection in patients treated by rheumatologists in the post-rofecoxib era
Greenberg, J; Yazici, Y; Kremer, JM; Chang, H; Kishimoto, M; Abramson, SB
2006 SEP ;54(9):S110-S110, Arthritis & rheumatism
— id: 70106, year: 2006, vol: 54, page: S110, stat: Journal Article,

RAPID (Rheumatology assessment patient index data), a simple, easy to use patient reported outcome index, is strongly correlated with DAS28 and CDAI indices when monitoring rheumatoid arthritis (RA) patients in routine care
Kishimoto, M; Tokuda, Y; Yazici, Y
2006 SEP ;54(9):S350-S350, Arthritis & rheumatism
— id: 70115, year: 2006, vol: 54, page: S350, stat: Journal Article,

Medication dose and dosing interval change when using TNF inhibitors among 4620 rheumatoid arthritis (RA) patients between 2003-2005
Krasnokutsky, S; Barnes, JP; Hines, PL; Yazici, Y
2006 DEC ;54(12):4098-4098, Arthritis & rheumatism
— id: 70762, year: 2006, vol: 54, page: 4098, stat: Journal Article,

TNF inhibitor switching patterns in 4620 rheumatoid arthritis (RA) patients between 2003-2005
Krasnokutsky, S; Barnes, JP; Hines, PL; Yazici, Y
2006 DEC ;54(12):4101-4101, Arthritis & rheumatism
— id: 70763, year: 2006, vol: 54, page: 4101, stat: Journal Article,

Behcet's syndrome patients have similar levels of functional disability, pain and more fatigue compared to rheumatoid arthritis patients
Moses, N; Fisher, M; Yazici, Y
2006 DEC ;54(12):4093-4094, Arthritis & rheumatism
— id: 70761, year: 2006, vol: 54, page: 4093, stat: Journal Article,

Rheumatoid arthritis patient index data (RAPID): Performance in two abatacept clinical trials of 4 absolute indices of 2-5 core data set measures based on patient reported outcomes for use in standard clinical care
Pincus, T; Bergman, M; Yazici, Y; Raghupathi, K; Hines, P; Maclean, R
2006 SEP ;54(9):S375-S375, Arthritis & rheumatism
— id: 70117, year: 2006, vol: 54, page: S375, stat: Journal Article,

Time to score various formats of a multi-dimensional health assessment questionnaire (MDHAQ): Which format would be best for standard clinical care?
Pincus, T; Bergman, M; Yazici, Y; Roth, J; Swearingen, C
2006 SEP ;54(9):S703-S704, Arthritis & rheumatism
— id: 70131, year: 2006, vol: 54, page: S703, stat: Journal Article,

How much does a visual analog scale (VAS) for fatigue add to VAS measures of pain and global estimate?
Pincus, T; Bergman, M; Yazici, Y; Swearingen, C
2006 SEP ;54(9):S704-S704, Arthritis & rheumatism
— id: 70132, year: 2006, vol: 54, page: S704, stat: Journal Article,

Comparisons of a self-report rheumatoid arthritis disease activity index (RADAI) joint count to physician-generated joint counts and other American college of rheumatology (ACR) core data set measures for rheumatoid arthritis (RA)
Pincus, T; Sokka, T; Yazici, Y; Bergman, M; Swearingen, C
2006 SEP ;54(9):S803-S803, Arthritis & rheumatism
— id: 70136, year: 2006, vol: 54, page: S803, stat: Journal Article,

A self-report new patient questionnaire which includes a standard medical history and assessment of health status: A translation template to facilitate communication between a health professional and patient who do not speak the same language
Pincus, T; Yazici, Y
2006 SEP ;54(9):S605-S605, Arthritis & rheumatism
— id: 70127, year: 2006, vol: 54, page: S605, stat: Journal Article,

Rapid-pro: Rheumatology assessment patient index data (RAPID), an absolute index of patient reported outcomes (PRO) without joint counts, scored in 15 seconds for standard clincial care
Pincus, T; Yazici, Y; Bergman, M
2006 JUL ;65(4B):497-497, Annals of rheumatic diseases
— id: 74198, year: 2006, vol: 65, page: 497, stat: Journal Article,

Simplified formats of visual analog scales for use in standard rheumatology clinical care: Agreement between a 10 cm horizontal line and 21 numbered circles
Pincus, T; Yazici, Y; Bergman, M; Goodin, V; Sokka, T; Swearingen, C
2006 SEP ;54(9):S345-S346, Arthritis & rheumatism
— id: 70113, year: 2006, vol: 54, page: S345, stat: Journal Article,

A proposed approach to recognise "near-remission" quantitatively without formal joint counts or laboratory tests: a patient self-report questionnaire routine assessment of patient index data (RAPID) score as a guide to a "continuous quality improvement" s
Pincus, T; Yazici, Y; Bergman, M; Swearingen, C; Harrington, T
2006 Nov-Dec;24(6 Suppl 43):S-60, Clinical & experimental rheumatology
A proposed approach is presented to recognise a status of 'near-remission' in a patient with rheumatoid arthritis (RA) on the basis of patient self-report questionnaire data without formal joint counts or laboratory tests. Indices of patient-reported outcome (PRO) measures distinguish active from control treatments in RA clinical trials at levels similar to American College of Rheumatology (ACR) or disease activity score (DAS) 28 improvement levels. PRO measures on a multidimensional health assessment questionnaire (MDHAQ) can be compiled into a routine assessment of patient index data (RAPID) score. RAPID 3 includes the three PRO measures from the ACR Core Data Set - physical function, pain, and global estimate. RAPID 4 adds a self-report joint count from a rheumatoid arthritis disease activity index (RADAI). RAPID 5 adds a physician estimate of global status. RAPID cores may be classified into four preliminary proposed categories, as 'near-remission' (0-1), 'low severity' (1.01-2), 'moderate severity' (2.01-4), and 'high severity' (> 4), analogous to the four categories of the DAS28 of 'remission' (< 2.6), as well as 'low' (2.6-3.19), 'moderate' (3.2-5.1), and 'high' (> 5.1) disease activity. RAPID scores are correlated significantly with DAS28 (rho = 0.64-0.67, p < 0.001), and about 75% of patients with DAS < 2.6 have RAPID scores < 2, while about 75% of patients with DAS > 5.1 have RAPID scores > 4. RAPID data are available on one side of one page, and are feasible to collect in standard clinical care. RAPID 3 scores may be calculated in about 10 seconds, and RAPID 4 and RAPID 5 scores in 20 to 30 seconds. RAPID scores every 3 months or more on simple flowsheets can be a basis for a 'continuous quality improvement' strategy in standard clinical care to recognise a need for aggressive therapy, an inadequate response to a therapy, and 'near- remission' status
— id: 90173, year: 2006, vol: 24, page: S, stat: Journal Article,

Saving time and improving care with a multidimensional health assessment questionnaire: 10 practical considerations
Pincus, Theodore; Yazici, Yusuf; Bergman, Martin
2006 Mar;33(3):448-454, Journal of rheumatology
— id: 69322, year: 2006, vol: 33, page: 448, stat: Journal Article,

Why are only 50% of courses of anti-tumor necrosis factor agents continued for only 2 years in some settings? Need for longterm observations in standard care to complement clinical trials
Pincus, Theodore; Yazici, Yusuf; van Vollenhoven, Ronald
2006 Dec;33(12):2372-2375, Journal of rheumatology
— id: 90170, year: 2006, vol: 33, page: 2372, stat: Journal Article,

C-reactive protein (CRP) is poorly correlated with individual ACR core data set measures of outcome among patients with rheumatoid arthritis
Pisoni, C; Yazici, Y; Tokuda, Y; Kishimoto, M
2006 JUL ;65(4B):495-495, Annals of rheumatic diseases
— id: 74196, year: 2006, vol: 65, page: 495, stat: Journal Article,

Denosumab in postmenopausal women with low bone mineral density
Schwartzman, Julie; Yazici, Yusuf
2006 Jun 1;354(22):2390-2391, New England journal of medicine
— id: 69321, year: 2006, vol: 354, page: 2390, stat: Journal Article,

Should joint limited motion or deformity be recorded in joint count?
Sokka, T; Kautiainen, H; Luukkainen, R; Horslev-Petersen, K; Holmqvist, AC; Belmonte, M; Alten, R; Pohl, C; Cazzato, M; Huisman, M; Sibilia, J; Woolf, A; Bresnihan, B; Minnock, P; Gogus, F; Toloza, S; Yazici, Y; Sadkiewicz, S; Majdan, M; Pincus, T
2006 SEP ;54(9):S204-S205, Arthritis & rheumatism
— id: 70108, year: 2006, vol: 54, page: S204, stat: Journal Article,

Podcasting as a new instrument for web based educational programs: The experience of "Rheumatology Radio"
Stancati, A; Sokka, T; Yazici, Y; Salaffi, F; Bombardieri, S
2006 JUL ;65(4B):620-620, Annals of rheumatic diseases
— id: 74203, year: 2006, vol: 65, page: 620, stat: Journal Article,

Low concordance between DAS28 and rapid, a patient-only scale, in a routine care rheumatoid arthritis cohort: What should be the "gold standard"?
Swearingen, C; Yazici, Y
2006 JUL ;65(4B):608-608, Annals of rheumatic diseases
— id: 74201, year: 2006, vol: 65, page: 608, stat: Journal Article,

Methotrexate induced pancytopenia is rare and concern for it should not limit its use
Yazici, Y
2006 MAR ;45(3):361-361, Rheumatology (Oxford)
— id: 62676, year: 2006, vol: 45, page: 361, stat: Journal Article,

Changing patterns of Anti-TNF medication use in 9074 rheumatoid arthritis patients between 2000-2005: Shorter treatment duration and quicker switching between Anti-TNF agents, with less than 50% of patients still on initial Anti-TNF medication at 2 years
Yazici, Y; Barnes, JP; Hines, PL
2006 SEP ;54(9):S350-S350, Arthritis & rheumatism
— id: 70114, year: 2006, vol: 54, page: S350, stat: Journal Article,

Clinical disease activity index (CDAI) is strongly correlated with DAS28 and change in CDAI is a strong predictor of ACR 20 response
Yazici, Y; Greenberg, J; Reed, G; Hinkle, K; Abramson, S; Kremer, J
2006 JUL ;65(4B):608-608, Annals of rheumatic diseases
— id: 74202, year: 2006, vol: 65, page: 608, stat: Journal Article,

Decreasing disease activity thresholds for initiating TNF antagonists from 2003 to 2005 among 1790 rheumatoid arthritis (RA) patients from the CORRONA database
Yazici, Y; Greenberg, J; Reed, G; Kishimoto, M; Hinkle, K; Abramson, S; Kremer, J
2006 SEP ;54(9):S246-S246, Arthritis & rheumatism
— id: 70110, year: 2006, vol: 54, page: S246, stat: Journal Article,

Reduced TNF utilization in early rheumatoid arthritis (RA) versus late RA in a US cohort
Yazici, Y; Greenberg, J; Reed, G; Kishimoto, M; Hinkle, K; Abramson, S; Kremer, J
2006 JUL ;65(4B):513-513, Annals of rheumatic diseases
— id: 74199, year: 2006, vol: 65, page: 513, stat: Journal Article,

Patient self report outcomes are as accurate measures for disease activity as physician-derived measures in patients with rheumatoid arthritis
Yazici, Y; Pisoni, C; Tokuda, Y; Kishimoto, M
2006 JUL ;65(4B):495-495, Annals of rheumatic diseases
— id: 74197, year: 2006, vol: 65, page: 495, stat: Journal Article,

TNF inhibitors (TNFi): Useful additional therapy to methotrexate (MTX) in rheumatoid arthritis patients with severe disease
Yazici, Y; Yazici, H
2006 SEP ;54(9):S246-S247, Arthritis & rheumatism
— id: 70111, year: 2006, vol: 54, page: S246, stat: Journal Article,

TNF inhibitors: Useful additional therapy to methotrexate in rheumatoid arthritis patients with severe disease
Yazici, Y; Yazici, H
2006 JUL ;65(4B):513-514, Annals of rheumatic diseases
— id: 74200, year: 2006, vol: 65, page: 513, stat: Journal Article,

Monitoring outcomes of arthritis and longitudinal data collection using patient questionnaires in routine care
Yazici, Yusuf
2006 ;64(1-2):40-44, Bulletin of the NYU Hospital for Joint Diseases
Though quantitative data might lead to improved information for clinical decisions, at the present time decisions in routine rheumatology practice generally are based largely on qualitative impressions, rather than on data. Patient questionnaires are readily accessible tools that the rheumatologist can use to go beyond impressions and to institute evidence-based guidelines appropriate to his or her own patient population and practice style. The Health Assessment Questionnaire (HAQ) and its derivatives have been shown to be the best predictors of functional and work disability, costs, joint replacement surgery, and mortality. Such questionnaires are at least as good as joint counts, radiographs, and laboratory tests in predicting these outcomes. Every encounter of a patient with a rheumatologist provides an opportunity to collect data. Based on experience with the Brooklyn Outcomes of Arthritis Registry Database, the author advocates distributing a waiting-room questionnaire to every patient who comes for an office visit. Potential benefits of recording questionnaire-based information include identifying trends or important changes in a patient's pain or physical function, providing a baseline for success with various treatment strategies for conditions of the rheumatologist's own practice, allowing patients an opportunity to express concerns, encouraging patients to disclose information they may feel is too minor to mention, and providing control data for research studies. A short questionnaire designed specifically for clinical, rather than research, use does not create a burden for office staff. Consistent use of patient questionnaires and systematic storage of the information gained can help document, track, and improve patient care in routine rheumatology practice
— id: 69319, year: 2006, vol: 64, page: 40, stat: Journal Article,

NYU Hospital for Joint Diseases - 2006 Seminar in Advanced Rheumatology
Yazici, Yusuf; Abramson, Steven
2006 ;64(1-2):8-8, Bulletin of the NYU Hospital for Joint Diseases
— id: 71292, year: 2006, vol: 64, page: 8, stat: Journal Article,

Trial of etanercept and methotrexate with radiographic and patient outcomes two-year clinical and radiographic results: Comment on the article by van der Heijde et al
Yazici, Yusuf; Yazici, Hasan
2006 Aug 31;54(9):3061-3062, Arthritis & rheumatism
— id: 67862, year: 2006, vol: 54, page: 3061, stat: Journal Article,

Use of statistical analysis in open extension studies
Yazici, Yusuf; Yazici, Hasan
2006 Feb;33(2):437-437, Journal of rheumatology
— id: 69323, year: 2006, vol: 33, page: 437, stat: Journal Article,

Laboratory monitoring of biologic therapies
Cush, JJ; Yazici, Y
2005 SEP-OCT ;23(5):S90-S92, Clinical & experimental rheumatology
The purpose of this report is to provide suggested guidance concerning the monitoring of TNF blocker therapy. Since the completion of randmized trials, several new long-term safety concerns have arisen, involving mycobacterial and opportunistic infections, cytopenias, lymphoma, demyelinating disease. drug-induced lupus, congestive heart failure and hepatotoxicity. Since these serious events are rare, widespread post-marketing use and prolonged follow-up have been required to analyze their prevalence. Monitoring of TNF inhibitors is necessary to reassure physicians and patients of the continued efficacy and safety of these drugs. No published recommendations on monitoring are available The clinician must weigh the potential clinical bebfits of TNF inhibition against potential adverse effects. Patients should be evaluated carefully for the risk or presence of infection, tuberculosis and other serious adverse events by regular visits, careful clinical assessments, and an assiduous, high index of suspicion for these rare events. Tuberculin skin testing using PPD is recommended before starting treatment with any TNF inhibitor
— id: 58903, year: 2005, vol: 23, page: S90, stat: Journal Article,

Inclusion criteria as widely used for rheumatoid arthritis clinical trials: Patient eligibility in a Turkish cohort
Gogus, F; Yazici, Y; Yazici, H
2005 SEP-OCT ;23(5):681-684, Clinical & experimental rheumatology
Objective. To identify, the proportion of patients fulfilling the inclusion criteria widely used in most clinical trials for rheumatoid arthritis (RA) - including the recent clinical trials of anti-Tinnor Necrosis Factor a (TNF alpha) agents - in a Turkish cohort. Methods. 186 consecutive RA patients attending a routine tertiary rheumatology clinic were evaluated in 2 groups: Early RA group (group E): 31 patients with a disease duration of ! 3 years (mean: 1.9 +/- 0.9 years); late RA group (group L): 155 patients with a disease duration of > 3 years (mean: 13.3 +/- 8.6 years). Patients were evaluated according to 2 different sets of inclusion criteria: (i) The widely used common inclusion criteria for RA clinical studies, as outlined by Sokka and Pincus; (ii) the criteria of two major anti-TNF clinical studies, ERA and ATTRACT. Results. No patients in group E, and 9 (6%) patients in group L fulfilled the common criteria used in clinical studies for RA. In group E, 28 patients had already been started on methotrexate; 2 patients were on sulphasalazine and one patient was on leflunomide. Nevertheless, even if the criterion for previous use of methotrexate was not applied patients did not fulfill the rest of the criteria of ERA study In group L, 9 out of 155 patients (6%) met the criteria for the ATTRACT study Conclusion. Only few patients met the widely used inclusion criteria for most RA clinical trials and the recent clinical trials of TNFa agents in this Turkish cohort. This may be explained by the milder disease activity in this geographical region, which further emphasizes the need to consider development of new criteria for inclusion in clinical trials
— id: 57927, year: 2005, vol: 23, page: 681, stat: Journal Article,

Development of a multi-dimensional health assessment questionnaire (MDHAQ) for the infrastructure of standard clinical care
Pincus, T; Yazici, Y; Bergman, M
2005 Sep-Oct;23(5 Suppl 39):S19-S28, Clinical & experimental rheumatology
The HAQ has become the pre-eminent patient questionnaire used in rheumatology. It is easily completed by patients, but not easily reviewed and scored in standard clinical care and has some minor psychometric limitations, as do all questionnaires. Modifications of the HAQ been made to facilitate use in standard care, particularly to include 8-10 activities of daily living, along with scores for pain and global status and other information on one side of one page for rapid review by the clinician. A patient questionnaire for standard care should be limited to 2 sides of 1 page, in a format amenable to 'eyeball' review by the clinician in 5 seconds or less. It can be scored formally in 15-20 seconds or less, and is useful in patients with all rheumatic diseases. The current version of a multi-dimensional HAQ (MDHAQ) includes scoring templates on the questionnaire to allow formal scoring in less than 15 seconds by a rheumatologist or an assistant, for possible entry onto a paper and/or computerized flow sheet. Various versions of the MDHAQ may also include a 'constant' region of physical function, pain and patient global status, and 'variable' regions of fatigue, morning stiffness, psychological distress, change in status, a review of systems, a rheumatoid arthritis disease activity self-report joint count (RADAI), review of recent health events, and review of medications. The MDHAQ can be used in the infrastructure of rheumatology care to include quantitative data in standard care of all patients with all rheumatic diseases
— id: 90192, year: 2005, vol: 23, page: S19, stat: Journal Article,

Scoring templates on a patient questionnaire to calculate routine Apgar-like patient index data (RAPID) absolute scores on a multidimensional health assessment questionnaire (MDHAQ) in standard care without a calculator, ruler, or computer
Pincus, T; Yazici, Y; Bergman, M
2005 SEP ;52(9):S413-S413, Arthritis & rheumatism
— id: 59282, year: 2005, vol: 52, page: S413, stat: Journal Article,

Radiographic benefit without clinical improvement in infliximab-treated patients with rheumatoid arthritis: comment on the article by Smolen et al
Pincus, Theodore; Yazici, Yusuf; Yazici, Hasan; Kavanaugh, Arthur F; Kremer, Joel M; Wolfe, Frederick
2005 Dec;52(12):4044-4045, Arthritis & rheumatism
— id: 69324, year: 2005, vol: 52, page: 4044, stat: Journal Article,

DMARD therapy for rheumatoid arthritis (RA) in routine care: improved outcomes at 6 and 12 months, with more significant results in methotrexate treated patients
Swearingen, C; Yazici, Y
2005 JUL ;64(4):218-218, Annals of rheumatic diseases
— id: 57654, year: 2005, vol: 64, page: 218, stat: Journal Article,

A database in private practice: the Brooklyn Outcomes of Arthritis Rheumatology Database (BOARD)
Yazici, Y
2005 Sep-Oct;23(5 Suppl 39):S182-S187, Clinical & experimental rheumatology
Rheumatologists generally use few quantitative measures in making clinical decisions. In the US, fewer than 10% use questionnaires in routine clinical care, and fewer than 15% perform a formal joint count at each visit. Patient questionnaires are the quantitative tools rheumatologists have to monitor their patients' health status and response to therapy. The health assessment questionnaire (HAQ) and its derivatives have been shown to be the best predictors of functional and work disability, costs, joint replacement surgery and mortality; they are as good as and usually better predictors than joint counts, radiographs and laboratory tests. The Brooklyn Outcomes of Arthritis Registry Database was initiated with the aim of collecting quantitative data using a multi-dimensional health assessment questionnire (MDHAQ) from all rheumatology patients seen as part of routine care, each and every time the patient was seen. Data that are feasible to collect in routine clinical care provide the only way to assess quantitatively how our patients are doing. If data are not collected and recorded, an opportunity is lost forever. If there is a reason for the visit, there is a reason to complete a questionnaire
— id: 61852, year: 2005, vol: 23, page: S182, stat: Journal Article,

Methotrexate use in rheumatoid arthritis is associated with few clinically significant liver function test abnormalities
Yazici, Y; Erkan, D; Harrison, MJ; Nikolov, NP; Paget, SA
2005 JUL-AUG ;23(4):517-520, Clinical & experimental rheumatology
Objective. To determine the frequency of liver function tests (LFT) abnormalities associated with methotrexate (MTX) use in the treatment of rheumatoid arthritis (RA). Methods. A retrospective chart review for demographic information, RA-specific history, medication history, complications of therapy, results of all available blood tests (specifically aspartate amino-transferase (AST), alanine amino-transferase (ALT),complete blood count (CBC), albumin, creatinine), and liver biopsy reports was conducted for RA patients, who were currently using or have used MTX in the past. Results. A total of 2 791 LFTs were performed among 182 RA patients with 94 abnormal results. 152 patients (83.5%) with 2007 LFT evaluations demonstrated no abnormal results, compared with 30 patients (16.5%) who had at least one abnormal LFT in 784 tests. Twenty-two of the 30 patients with at least one LFT abnormality (73.3%) continued treatment despite the elevation without further evaluation or change in therapy, and subsequent LFT assessments were within normal limits. 128 patients (70.3%) remained on MTX at the time of our study The most common reason for discontinuation was inadequate response. Conclusions. MTX appears to be associated with very few clinically significant hepatic side effects. In view of these data, consideration as to revision of the current MTX monitoring guidelines in the direction of less frequent monitoring, especially in patients with no risk factors for liver disease, may be considered
— id: 57651, year: 2005, vol: 23, page: 517, stat: Journal Article,

Long term safety of methotrexate in routine clinical care: discontinuation is unusual and rarely the result of laboratory abnormalities
Yazici, Y; Sokka, T; Kautiainen, H; Swearingen, C; Kulman, I; Pincus, T
2005 Feb;64(2):207-211, Annals of rheumatic diseases
OBJECTIVE: To analyse patients with rheumatoid arthritis, treated with methotrexate in a weekly academic rheumatology clinic over 13 years, for continuation of courses and reasons for discontinuation. METHODS: All 248 patients with an analysable longitudinal course who took methotrexate in standard care between 1990 and 2003 were studied. Continuation of courses was analysed using life tables. All abnormal and severely abnormal values for aspartate aminotransferase (AST) >40 U/l, >80 U/l, albumin <35 g/l, <30 g/l, white blood cell (WBC) count <4.0 x 10(9)/l, <3.0 x 10(9)/l, and platelet count <150 x 10(9)/l, <100 x 10(9)/l, were identified. Responses of the clinician and subsequent laboratory values were reviewed. RESULTS: Over 1007 person-years, the probability of continuing methotrexate over five years was 79% (95% confidence interval, 72% to 84%). Severe laboratory abnormalities occurred in 2.9 per 100 person-years, specifically 0.9 for AST >80 U/l, 1.1 for albumin <30 g/l, 0.7 for WBC <3.0 x 10(9)/l, and 0.3 for platelets <100 x 10(9)/l. No severe laboratory abnormality progressed to further severity or clinical disease. Permanent discontinuations of methotrexate occurred in 46 patients (19%), 26 (10% of all patients) for adverse effects, 15 (32.6%) for inefficacy; only two discontinuations resulted from laboratory abnormalities, both of WBC, possibly from other sources. CONCLUSIONS: Methotrexate was associated with a high rate of continuation, and few clinically significant laboratory abnormalities. Discontinuation primarily reflected clinical rather than laboratory findings. Vigilance for methotrexate toxicity is required but methotrexate appears among the safest treatments for rheumatoid arthritis
— id: 90212, year: 2005, vol: 64, page: 207, stat: Journal Article,

In African-American and Hispanic minority patients with rheumatic disease (RA) in a US clinical setting are explained by a higher proportion of patients with more severe disease
Yazici, Y; Sokka, T; Ricciardi, DD; Pincus, T
2005 JUL ;64(4):191-191, Annals of rheumatic diseases
— id: 57653, year: 2005, vol: 64, page: 191, stat: Journal Article,

Adverse events (AE) are inadequately reported in randomized controlled trials (RCT) of TNF alpha and COX-2 inhibitors
Yazici, Y; Yazici, H
2005 SEP ;52(9):S654-S654, Arthritis & rheumatism
— id: 59295, year: 2005, vol: 52, page: S654, stat: Journal Article,

Morning stiffness in patients with early rheumatoid arthritis is associated more strongly with functional disability than with joint swelling and erythrocyte sedimentation rate
Yazici, Yusuf; Pincus, Theodore; Kautiainen, Hannu; Sokka, Tuulikki
2004 Sep;31(9):1723-1726, Journal of rheumatology
OBJECTIVE: To compare the level of morning stiffness in a cohort of patients with early rheumatoid arthritis (RA), assessed on a self-report questionnaire, to levels of patient self-report scores and clinical and laboratory variables. METHODS: A total of 337 patients with recent onset RA since 1998 were assessed for tender and swollen joint counts, erythrocyte sedimentation rate (ESR), physician global assessment, and radiographs of the hands and feet, as well as Multidimensional Health Assessment Questionnaire (MDHAQ) scores for functional disability, pain, fatigue, global status, morning stiffness, and number of symptoms. Regression models were used to estimate possible associations between these variables and morning stiffness. RESULTS: At study entry, 70 patients (21%) reported no morning stiffness, 52 (15%) reported morning stiffness < 15 minutes, 52 (15%) for 16-59 minutes, and 163 (49%) for >/= 1 one hour. At baseline and in longitudinal analyses, morning stiffness was significantly associated with functional disability scores on the MDHAQ and with other patient self-report data, and was associated at lower levels with swollen and tender joint counts and erythrocyte sedimentation rate (ESR). CONCLUSION: The degree of morning stiffness appears to reflect functional disability and pain more than traditional markers of inflammation such as joint counts and ESR in patients with early RA. Inclusion of morning stiffness as a marker of inflammatory activity in classification criteria for RA, inclusion criteria for most clinical trials in RA, and RA remission criteria, may be open to reassessment
— id: 69325, year: 2004, vol: 31, page: 1723, stat: Journal Article,

Analysis of risk factors and comorbid diseases in the development of thrombosis in patients with anticardiolipin antibodies: comment on the article by Sairam et al
Erkan, Doruk; Yazici, Yusuf
2003 Dec;22(6):493-493, Clinical rheumatology
— id: 69326, year: 2003, vol: 22, page: 493, stat: Journal Article,

Methotrexate as the "anchor drug" for the treatment of early rheumatoid arthritis
Pincus, T; Yazici, Y; Sokka, T; Aletaha, D; Smolen, J S
2003 Sep-Oct;21(5 Suppl 31):S179-S185, Clinical & experimental rheumatology
The two major advances over the 1990s in the treatment of rheumatoid arthritis (RA) were a shift in strategy from a 'pyramid', in which disease modifying anti-rheumatic drugs (DMARDs) were deferred for several years, to the early aggressive use of DMARDs and widespread acceptance of methotrexate as the DMARD with the most long-term effectiveness and safety. Methotrexate courses are continued far longer than those of any other DMARD, an excellent indicator of greater effectiveness and safety. In one recent series, methotrexate was the first DMARD used in more than 80% of patients with RA. Studies which document the superiority of combinations of methotrexate with biological agents to methotrexate monotherapy select for only a minority of contemporary patients with RA who have severe disease activity and incomplete responses to methotrexate. In one locale, only 5% of patients met criteria for the Anti-Tumor Necrosis Factor Trial in RA with Concomitant Therapy (ATTRACT) trial and only 30% met the criteria for the Early Rheumatoid Arthritis (ERA) trial. In studies comparing methotrexate directly with biological agents, the biological agents have greater efficacy in patients with very severe disease, but the best results are seen in patients who take a combination of methotrexate and biologic agents. These data establish that methotrexate is the anchor drug and probably should be the first DMARD used in the majority of patients with RA at this time
— id: 90218, year: 2003, vol: 21, page: S179, stat: Journal Article,

Databases of patients with early rheumatoid arthritis in the USA
Sokka, T; Willoughby, J; Yazici, Y; Pincus, T
2003 Sep-Oct;21(5 Suppl 31):S146-S153, Clinical & experimental rheumatology
Several databases of patients with early rheumatoid arthritis (RA) have been established in the USA. The University of Tennessee at Memphis Cohort was organized in 1967-1971 to enroll 50 young adults (16-44 years) with symptom onset of < or = 6 months who met the 1958 American Rheumatism Association (ARA) criteria for at least probable RA. Two important observations from this database were that many patients seen within the first 6 months of meeting the criteria for probable RA have a self-limited rather than progressive disease, and that progressive disease is predicted by a high number of baseline swollen and tender joints. The National Institutes of Health (NIH) cohort of patients with peripheral synovitis for > or = 6 weeks but < 12 months in at least one peripheral joint was established in 1994. At the one-year follow-up, 45% of the patients met the RA criteria, 9% had reactive arthritis, 6% had psoriatic arthritis, 5% had other rheumatic diseases, and 35% had undifferentiated arthritis. The number of active joints, rather than meeting the criteria for RA, was the primary determinant of function and performance after one year. The Western Consortium of Practicing Rheumatologists (CPR) was established in 1993 to enroll patients with an RA duration < 1 year, positive rheumatoid factor, > or = 6 swollen and > or = 9 tender joints, and no previous treatment with disease modifying anti-rheumatic drugs (DMARDs). Data from this cohort indicated the validity of self-report joint counts. American College of Rheumatology 20% improvement (ACR20) responses were seen in 50% of patients at 6 months and in 57% of patients at 24 months, while antinuclear antibodies (ANA) were seen in 69% of patients prior to the availability of biologic agents. The North American Cohort of Patients with Early RA (SONORA), which included patients with symptoms for > 3 but < 12 months, indicated that methotrexate (MTX) was the most frequently prescribed DMARD, being taken by more than half the patients. The Consortium for the Longitudinal Evaluation of African-Americans with RA (CLEAR) registry and DNA repository has enrolled 123 African-American patients with early RA of less than 2 years' duration to analyze genetic and non-genetic factors associated with disease severity. The Early RA Treatment Evaluation Registry (ERATER) of patients with early RA (< 3 years) was established in 2001. In this registry, MTX was the first DMARD used in 83% of patients, and most patients would not meet the criteria for inclusion in recent clinical trials of biological agents. Further observation of recent cohorts of patients with early RA over the next decade should be informative regarding whether aggressive intervention strategies and new DMARDs and biologic agents lead to improved long-term outcomes
— id: 90219, year: 2003, vol: 21, page: S146, stat: Journal Article,

Eligibility of rheumatoid arthritis patients seen in clinical practice for rheumatoid arthritis clinical trials: comment on the article by Sokka and Pincus
Yazici, Yusuf; Erkan, Doruk
2003 Dec;48(12):3611-3611, Arthritis & rheumatism
— id: 69327, year: 2003, vol: 48, page: 3611, stat: Journal Article,

Monitoring by rheumatologists for methotrexate-, etanercept-, infliximab-, and anakinra-associated adverse events
Yazici, Yusuf; Erkan, Doruk; Paget, Stephen A
2003 Oct;48(10):2769-2772, Arthritis & rheumatism
OBJECTIVE: To determine what monitoring protocols rheumatologists use to identify adverse events in rheumatoid arthritis (RA) patients treated with methotrexate (methotrexate), etanercept (etanercept), infliximab (infliximab), and anakinra (anakinra), how often rheumatologists encounter treatment-altering adverse events in their RA patients receiving these treatments, and how they feel about and comply with the current monitoring guidelines. METHODS: Three hundred ten physician members of the American College of Rheumatology (ACR) were notified by e-mail of a survey that was posted on our rheumatology Web site. Questions were closed-ended and multiple choice in format. RESULTS: One hundred twenty-three responses were received (40%). Most rheumatologists reported that they utilize the ACR recommended screening tests at baseline before methotrexate treatment is initiated. Seventy-nine percent reported that treatment-altering abnormalities had occurred in <5% of their methotrexate-treated RA patients, and 88% reported that such abnormalities had occurred in <10% of such patients, in the previous 3 years. Forty-one percent believed liver function monitoring guidelines need to be changed; 59% said they would agree with new guidelines that would include a recommendation for liver function monitoring every 3-4 months. Most rheumatologists were not aware of any guidelines for monitoring by blood tests in RA patients treated with biologic agents, yet the majority reported that they order blood tests before patients start these therapies and on followup. CONCLUSION: Our survey indicates that treatment-altering liver function abnormalities in methotrexate-treated RA patients are rare, and more than half of rheumatologists agree that a less stringent monitoring regimen should be considered. Rheumatologists and pharmaceutical companies might work together to develop guidelines for monitoring of patients treated with biologic agents
— id: 69328, year: 2003, vol: 48, page: 2769, stat: Journal Article,

Pregnancy outcomes following total hip arthroplasty: a preliminary study and review of the literature
Yazici, Yusuf; Erkan, Doruk; Zuniga, Ricardo; Bateman, Helen; Salvati, Eduardo A; Magid, Steven K
2003 Jan;26(1):75-76, Orthopedics (Thorofare NJ)
Pregnancy outcomes among patients who underwent total hip arthroplasty (THA) during their reproductive years were retrospectively evaluated. Twenty-one patients reported pregnancies after THA and 20 had live births. No prosthesis-related problems were reported. This is the first study that provides a patient-based assessment of pregnancy outcomes and delivery in women who underwent THA. The preliminary data suggest THA had no adverse effect on subsequent childbearing
— id: 69329, year: 2003, vol: 26, page: 75, stat: Journal Article,

The role of cardiac magnetic resonance imaging in antiphospholipid syndrome
Erkan, Doruk; Erel, Hale; Yazici, Yusuf; Prince, Martin R
2002 Dec;29(12):2658-2659, Journal of rheumatology
— id: 69331, year: 2002, vol: 29, page: 2658, stat: Journal Article,

Cardiac involvement in myositis
Yazici, Yusuf; Kagen, Lawrence J
2002 Nov;14(6):663-665, Current opinion in rheumatology
After careful examination, cardiac involvement can be found in certain patients with inflammatory muscle disease. The clinical significance is not always clear, although in some patients profound disturbances can become manifest. Currently, no laboratory assay can be relied on to detect cardiac disease with 100% accuracy. Cardiac troponin I is, however, the best test currently available
— id: 69332, year: 2002, vol: 14, page: 663, stat: Journal Article,

Clinical presentation of the idiopathic inflammatory myopathies
Yazici, Yusuf; Kagen, Lawrence J
2002 Nov;28(4):823-832, Rheumatic diseases clinics of North America
The hallmark of the inflammatory myopathies is muscle weakness. Although this feature can lead to significant disability and impairment of activities of daily living, its initial presentation may not be recognized early. Older individuals, in particular, may feel that the changes caused by myositis reflect the effects of aging rather than those of a disease process, and diagnosis, therefore, may be delayed. This factor has negative impact on the response to therapy. Inclusion body myositis, with its insidious onset in older people, and laboratory findings which may not be markedly abnormal, presents a diagnostic challenge. DM, with its characteristic symptomatic rash, is generally brought to medical attention more quickly. Another area of diagnostic concern occurs when associated organ involvement precedes myopathy. This has been observed, for example, with interstitial lung disease, and again represents a challenge to physicians. In this connection, the antisynthetase syndrome presenting with fevers, Raynaud's features, arthritis, or pulmonary involvement may not initially be recognized as a manifestation of inflammatory muscle disease. Each subgroup of IIM may present with a variety of extramuscular features that can complicate diagnosis and alter therapy and prognosis. This is particularly true for the pulmonary, GI, and cardiac manifestations and when cancer is associated with myositis. For these reasons, such features of IIM should be carefully evaluated, treated, and monitored over the course of the illness; in some cases these may play a greater role in determining the outcome of patients with IIM than the muscle involvement itself. It is hoped that in the future increased familiarity with the manifestations of the inflammatory myopathies, together with a better understanding of the underlying pathogenesis, will lead to more rapid diagnosis and more effective treatments
— id: 69330, year: 2002, vol: 28, page: 823, stat: Journal Article,

High thrombosis rate after fetal loss in antiphospholipid syndrome: effective prophylaxis with aspirin
Erkan, D; Merrill, J T; Yazici, Y; Sammaritano, L; Buyon, J P; Lockshin, M D
2001 Jun;44(6):1466-1467, Arthritis & rheumatism
— id: 73546, year: 2001, vol: 44, page: 1466, stat: Journal Article,