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Comparative effectiveness and time to response among adalimumab, abatacept, etanercept, infliximab and rituximab in a real world routine care registry [Meeting Abstract]
Yazici, Y; Regens, A L; Swearingen, C J
Background With the availability of multiple biologic agents, with different modes of action, and no head to head trials, it is of use to examine comparative effectiveness of these agents in real world registries to inform physicians how they might be used for the treatment of rheumatoid arthritis. Objectives To compare time to response and efficacy among biologic agents. Methods Usage of the biologic medications abatacept, adalimumab, etanercept,infliximab and rituximab along with self-reported disease activity and clinic measures were abstracted from ARMD registry at NYU. Time to first response defined as an improvement in RAPID3 of at least 3.6 was calculated; change from biologic medication initiation to first response for self-reported disease activity and clinic measures was estimated. Differences in time to first response between biologic medications were estimated using Cox proportional hazards model. Results 4299 encounteres were reviewed for this analysis. A total of 526 treatment courses were determined. 406 of 526 courses represent the first biologic medication used by an individual; 88 individuals used two biologic medications at different times, while 26 had used three biologics, and 6 had used 4. Abatacept had more patients achieve response (66%) characterized by a reduction in RAPID of 3.6 points or greater than adalimumab (63%), etanercept (61%), infliximab (43%), rituximab (41%) although this difference was not statistically siginficant. Increased age and increased duration of disease were associated with decreased likelihood of achieving a RAPID3 reponse. Time to reponse in the first 6 months after treatment was not significantly different among any of the biologics Conclusions No differences in efficacy and time to response among adalimumab, abatacept, etanercept, infliximab or rituximab in the first 6 months after RA treatment was initiated were noted. With no difference in clinical outcomes, most treatment decisions may be based on ease of use and safety data of respective!
EMBASE:71327893
ISSN: 0003-4967
CID: 837402
Response to treatment with azathioprine in behcet's syndrome patients with different organ involvement and documentation of improvement using patient reported outcomes in routine clinical care [Meeting Abstract]
Yazici, Y; Regens, A L; Swearingen, C J
Background Behcet's syndrome (BS) is a systemic vasculitis that may different pathogenic mechanisms leading to different manifestations, such as eye, mucocutaneous and GI disease. We started a dedicated Behcet's clinic in 2004 and have treated over 850 patients to date. Objectives To determine the response to therapy depending on type of organ involvement and documentation of improvement with patient reported outcomes. Methods All patients seen at the Center complete MDHAQ, medical history, medication use, Behcet's specific history, ethnic and demographic information forms. In addition a Behcet Syndrome Activity Score (BSAS) is also completed by all Behcet patients. These data are prospectively collected and updated each visit. Patients were divided into eye disease only, GI only, both or none groups and compared for disease activity and medication, specifically azathioprine, use. They could have mucocutaneous disease in addition to above manifestations Results 484 patients (78% female, disease duration 4.8 (7.1) years, age 35.3 (13.8)) were analyzed. 244 patients had no eye or GI disease, 83 had eye, 111 GI and 46 both eye and GI involvement. Both groups of azathioprine treated and untreated patients showed improvement in their disease activity scores but the improvement were more pronounced for GI disease by BSAS. RAPID3 responses were more in the azathioprine treated group with eye and both eye and GI disease. Patients with no eye or GI disease did similarly with or without azathioprine. (Table presented) Conclusions In this cohort of 484 Behcet patients, some treatment response differences were noted between patients with eye or GI involvement vs those who did not have these. Overall, azathioprine, led to better outcomes regardless of organ involvement. It was possible to demonstrate these improvements using patient reported outcomes, RAPID3 and BSAS, as part of routine clinical care
EMBASE:71327567
ISSN: 0003-4967
CID: 837422
MODERATE/SEVERE DISEASE ACTIVITY VS LOW DISEASE ACTIVITY/REMISSION: PATIENT CHARACTERISTICS AND DIFFERENCES AMONG PATIENTS FROM UNITED STATES AND TURKEY [Meeting Abstract]
Inanc, N.; Hatemi, G.; Simsek, I.; Ozen, G.; Tascilar, K.; Ugurlu, S.; Pay, S.; Erdem, H.; Yilmaz, S.; Cinar, M.; Swearingen, C. J.; Direskeneli, H.; Yazici, Y.
ISI:000331587903558
ISSN: 0003-4967
CID: 852912
TOO MANY PATIENTS IN RANDOMIZED CONTROLLED TRIALS (RCTS) OF RA? A CRITICAL REASSESMENT OF POWER AND THE ACTUAL NUMBERS OF PATIENTS ENROLLED [Meeting Abstract]
Celik, S.; Yazici, H.; Yazici, Y.
ISI:000331587903084
ISSN: 0003-4967
CID: 852982
REMISSION, LOW DISEASE ACTIVITY, AND ASSOCIATED CHANGES IN PHYSICAL FUNCTION AND RADIOGRAPHIC OUTCOMES WITH SUBCUTANEOUS ABATACEPT OR ADALIMUMAB: RESULTS FROM THE AMPLE TRIAL [Meeting Abstract]
Fleischmann, R.; Schiff, M.; Weinblatt, M.; Maldonado, M.; Massarotti, E.; Yazici, Y.
ISI:000331587903623
ISSN: 0003-4967
CID: 852992
LESS EMPHASIS ON SELF CRITIQUE AMONG BASIC SCIENCE COMPARED TO CLINICAL SCIENCE MANUSCRIPTS IN RHEUMATOLOGY LITERATURE [Meeting Abstract]
Yazici, H.; Gogus, F.; Esen, F.; Yazici, Y.
ISI:000331587902458
ISSN: 0003-4967
CID: 853002
SCORES FOR PAIN AND FATIGUE EXPLAIN VARIATION IN PATIENT GLOBAL STATUS AT HIGHER SIGNIFICANCE THAN PHYSICAL FUNCTION IN PATIENTS WITH RHEUMATOID ARTHRITIS (RA), OSTEOARTHRITIS (OA), SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) AND GOUT SEEN IN USUAL CLINICAL CARE [Meeting Abstract]
Castrejon, I.; Yazici, Y.; Pincus, T.
ISI:000331587902461
ISSN: 0003-4967
CID: 853052
RELATIONSHIP BETWEEN EARLY DISEASE ACTIVITY STATUS AND STRUCTURAL AND FUNCTIONAL CHANGES IN MTX-NAIVE PATIENTS WITH EARLY RA TREATED WITH ABATACEPT PLUS MTX VERSUS MTX ALONE IN THE AGREE TRIAL [Meeting Abstract]
Smolen, J. S.; Yazici, Y.; Wollenhaupt, J.; Durez, P.; Gomez-Reino, J.; Grassi, W.; Le Bars, M.; Gaillez, C.; Poncet, C.; Westhovens, R.
ISI:000331587903600
ISSN: 0003-4967
CID: 853062
FORMAL EDUCATION LEVEL IS MORE EXPLANATORY OF VARIATION IN PATIENT GLOBAL ESTIMATE THAN AGE, DURATION OF DISEASE OR GENDER IN PATIENTS WITH RHEUMATOID ARTHRITIS, OSTEOARTHRITIS, SYSTEMIC LUPUS ERYTHEMATOSUS AND GOUT [Meeting Abstract]
Castrejon, I.; Yazici, Y.; Pincus, T.
ISI:000331587901353
ISSN: 0003-4967
CID: 853122
Early effects of tocilizumab in the treatment of moderate to severe active rheumatoid arthritis: a one-week sub-study of a randomised controlled trial (Rapid Onset and Systemic Efficacy [ROSE] Study)
Yazici, Yusuf; Curtis, Jeffrey R; Ince, Akgun; Baraf, Herbert S B; Lepley, Denise M; Devenport, Jenny N; Kavanaugh, Arthur
OBJECTIVES: Tocilizumab has demonstrated efficacy in managing rheumatoid arthritis (RA) from week 2 onward. This sub-study assessed effects of tocilizumab plus disease-modifying anti-rheumatic drugs (DMARDs) during the first week of therapy. METHODS: Rapid Onset and Systemic Efficacy was a 24-week, randomised, double-blind, placebo-controlled, parallel-group trial. Adults with moderate to severe active RA taking DMARDs received tocilizumab 8 mg/kg (or placebo) plus DMARDs every 4 weeks. Data were analysed from the first 62 patients at designated study sites who agreed to clinical evaluation and blood sampling at days 3 and 7 and had C-reactive protein levels >/=1 mg/dl. Outcomes included American College of Rheumatology core data set measures, disease activity score using 28 joints (DAS28) and routine assessment of patient index data 3 (RAPID3) scores. RESULTS: Baseline evaluations were similar between groups (tocilizumab, n=40; placebo, n=22). Patient global assessments of disease activity and pain improved significantly in favour of tocilizumab (mean change from baseline to day 7: -16.2 [tocilizumab], 0.8 [placebo] [p=0.005] and -12.2 [tocilizumab], 1.4 [placebo] [p=0.01], respectively). Physician global assessment of disease activity also improved more with tocilizumab (-15.4 [tocilizumab], -5.6 [placebo] [p=0.05]). Changes from baseline in tender/swollen joint counts, physical function and RAPID3 scores were not significantly different between groups. DAS28 significantly improved with tocilizumab versus placebo at day 7 (-1.16 [tocilizumab], -0.27 [placebo] [p=0.007]). CONCLUSIONS: Tocilizumab showed significant improvement in patient-reported disease activity, pain and DAS28 score as early as day 7 after first infusion, earlier than physician-reported measures, which may take longer to manifest.
PMID: 23305631
ISSN: 0392-856x
CID: 346372