SAT0007 SUSTAINED EFFICACY OF REPEAT TREATMENT COURSES OF RITUXIMAB IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO DISEASE-MODIFYING ANTI-RHEUMATIC DRUGSP. Emery1, D. E. Furst2, G. Ferraccioli3, J. Udell4, R. F. van Vollenhoven5, K. Rowe6, S. Agarwal7, T. Shaw6
1Rheumatology, Leeds General Infirmary, Leeds, United Kingdom, 2Rheumatology Clinical Research Center, University of California at Los Angeles, Los Angeles, CA, United States, 3Rheumatology, Catholic University, Rome, Italy, 4Arthritis Group, Philadelphia, PA, United States, 5Rheumatology, Karolinska University Hospital, Stockholm, Sweden, 6Medical Sciences, Roche Products Ltd, Welwyn Garden City, United Kingdom, 7Clinical Development, Genentech, Inc, South San Francisco, CA, United States
Objectives: To provide an additional evaluation of the long-term efficacy of repeated courses of rituximab (RTX) treatment in patients (pts) with active rheumatoid arthritis (RA) and a previous inadequate response to disease-modifying anti-rheumatic drugs (DMARDs).
Methods: Data presented are from a September 2006 data cut of an ongoing open-label extension of two Phase II studies (1, 2). Pts were eligible for repeat treatment if they met predefined criteria: ≥20% improvement in SJC and TJC and residual disease activity defined as ≥8 SJC and TJC. The need for repeated courses was determined by each pt’s treating physician. Placebo-treated pts were also eligible for entry into the extension study. All courses of RTX treatment consisted of two infusions of RTX (1000 mg x 2) on Days 1 and 15; prior to each infusion, all pts received 100 mg IV methylprednisolone and treatment with oral glucocorticoids. All efficacy outcomes were assessed relative to the original pretreatment baseline.
Results: A total of 273 RA pts with a prior inadequate response to DMARDs had been exposed to ≥1 courses of RTX (1000 mg x 2 for each course) in the clinical programme. A total of 94 of these pts had received at least 3 courses (C) of RTX. The median time period between the treatment courses was 48.7 weeks for C1–C2 and 56.2 weeks for C2–C3. Efficacy data were available for 57 pts who, at the time of analysis, had reached at least 24 weeks of follow-up post-C3. A within-pt comparison of efficacy between treatment courses at 24 weeks showed sustained efficacy for all outcomes relative to the original baseline (Table).
Table:
Parameter |
Course 1 | Week 24 (n=57)
Course 2 |
Course 3 |
|
| ACR20, n (% of pts) | 34 (60) | 40 (70) | 37 (65) |
| ACR50, n (% of pts) | 14 (25) | 19 (33) | 19 (33) |
| ACR70, n (% of pts) | 4 (7) | 7 (12) | 7 (12) |
Low disease activity
(DAS28 ≤3.2), n (% of pts) | 12 (21) | 14 (25) | 18 (32) |
Remission
(DAS28 <2.6), n (% of pts) | 3 (5) | 5 (9) | 8 (14) |
DAS28 change from
original baseline, mean (SD) | -2.07 (1.29) | -2.46 (1.35) | -2.72 (1.54) |
|
| SD=standard deviation |
Conclusion: Our results show that repeated courses of RTX produce sustained efficacy in pts with active RA and a previous inadequate response to DMARDs.
References: 1. Edwards, et al. N Engl J Med 2004;350:2572–2581.
2. Emery, et al. Arthritis Rheum 2006;54:1390–1400.
