SAT0012 REPEATED TREATMENT COURSES OF RITUXIMAB IN RHEUMATOID ARTHRITIS: SUSTAINED EFFICACY IN PATIENTS WITH AN INADEQUATE RESPONSE TO ONE OR MORE TNF INHIBITORSE. Keystone1, R. M. Fleischmann2, P. Emery3, A. Chubick4, M. Dougados5, A. R. Baldassare6, J. M. Bathon7, E. Hessey8, D. Hagerty9, S. Cooper8
1Rheumatology, University of Toronto, Toronto, Canada, 2Radiant Research Center, Dallas, TX, United States, 3Rheumatology, Leeds General Infirmary, Leeds, United Kingdom, 4Rheumatology, Baylor University Medical Center, Dallas, TX, United States, 5Service de Rhumatologie B, Hopital Cochin, Paris, France, 6Internal Medicine, St Louis University, St Louis, MO, 7Rheumatology, Johns Hopkins University, Baltimore, MD, United States, 8Medical Sciences, Roche Products Ltd, Welwyn Garden City, United Kingdom, 9Rheumatology Clinical Research, Biogen Idec, San Diego, CA, United States
Objectives: As part of an updated analysis, to further explore the long-term efficacy of repeated courses of rituximab (RTX) therapy in patients (pts) with active rheumatoid arthritis (RA) who had a previous inadequate response to tumour necrosis factor (TNF) inhibitors.
Methods: Pts were enrolled in an ongoing open-label extension of Phase II and III studies (1–3). Each course of treatment with RTX consisted of two infusions of RTX (1000 mg x 2) 2 weeks apart; prior to each infusion, all pts received 100 mg IV methylprednisolone, with oral glucocorticoids administered between the 2 infusions. Eligibility for repeat treatment: predefined improvement (≥20% reduction of SJC and TJC), residual disease activity (defined as ≥8 SJC and TJC), in combination with the judgement of the treating physician. Placebo-treated pts could also enrol and receive RTX. In this completer analysis, all efficacy outcomes were assessed relative to the original pretreatment baseline.
Results: As of September 2006, a total of 571 RA pts with a prior inadequate response to ≥1 TNF inhibitors had been exposed to repeated courses of RTX (1000 mg x 2 for all courses) in the clinical programme. Of these, 210 pts had received ≥3 courses (C) of RTX. The median time period between the treatment courses was 37.9 weeks for C1–C2 and 42.1 weeks for C2–C3. Efficacy data were available for 97 pts who, at the time of analysis, had reached at least 24 weeks of follow-up post-C3. Comparison of efficacy between treatment courses at 24 weeks following C1, C2 and C3 showed sustained efficacy for all outcomes relative to original baseline (Table).
Table:
|
Course 1 | Week 24 (n=96 pts)a
Course 2 |
Course 3 |
|
| ACR20, n (% of pts) | 66 (69) | 73 (76) | 74 (77) |
| ACR50, n (% of pts) | 35 (36) | 46 (48) | 46 (48) |
| ACR70, n (% of pts) | 11 (11) | 18 (19) | 24 (25) |
Low disease activity
(DAS28 ≤3.2), n (% of pts) | 11 (11) | 25 (26) | 28 (29) |
Remission
(DAS28 <2.6), n (% of pts) | 6 (6) | 14 (14) | 12 (12) |
DAS28 change from original
baseline, mean (SD) | -2.39 (1.29) | -2.94 (1.46) | -3.10 (1.39) |
|
| an=97 pts for DAS-related outcomes; SD=standard deviation |
Conclusion: These results indicate that repeated courses of RTX produce sustained efficacy relative to original baseline in pts with active RA who had inadequately responded previously to TNF inhibitors and who remain on RTX 24 weeks after C3.
References: 1. Edwards, et al. N Engl J Med 2004;350:2572–2581.
2. Emery, et al. Arthritis Rheum 2006;54:1390–1400.
3. Cohen, et al. Arthritis Rheum 2006;54:2793–2806.
