AB0380 LONG-TERM RESPONSE TO RITUXIMAB IN 36 PATIENTS WITH RHEUMATOID ARTHRITIS: A SINGLE CENTRE EXPERIENCE.
L. Quartuccio*1, S. Salvin1, M. Regis1, S. Lombardi1, E. Mansutti1, M. Maset1, S. De Vita1
1Rheumatology Clinic, Azienda Ospedaliero-Universitaria, Udine, Italy
Background: The long-term management of rheumatoid arthritis (RA) with rituximab remains an open issue. Data from an open-label extension phase of the DANCER study (1) indicate that re-treatment with a full cycle of rituximab (1 g× 2) is again effective in previous responders to rituximab, who had relapsed in the follow-up. In addition, there was no evidence of cumulative toxicity despite ongoing B-cell depletion. B-cell depletion may induce qualitative effects on B and T cell, resulting in a biologic disease reset and in a clinical persistent response in the long term in a subset of RA patients.
Objectives: We describe the 12 long-term responders in a series of 36 consecutive, unselected RA patients treated with rituximab at the standard dose (1 g x 2) or at the lymphoma schedule (375 mg/m2 x 4 weeks) from 2000 to 2007. Long-term response was defined as a persistent ACR response during a period of at least 12 months.
Methods: Thirty-six patients with established RA (31 females, 5 males, mean age 59 years), were treated with rituximab 1 g x 2 (31/36) or 375 mg/m2 x 4 weeks (5/36). Seven patients underwent rituximab after DMARDs failure, while the remaining patients had failed or were intolerant to anti-TNF alpha therapy or anti-TNF therapy was contraindicated or dangerous based on the expert clinical judgment. Methotrexate at the dose of 10 to 15 mg/week was co-administered in 29/36. Other DMARDs were administered in 4 patients. Only low-doses of steroids, i.e. prednisone dose less than 5 mg or equivalents, were permitted.
Results: Seventy-three courses and an overall number of 174 infusions of rituximab were used in the 36 patients. Seventeen patients received at least 2 cycles, while more than 2 cycles were administered in 9 patients. Thirty out of 36 RA patients had a follow-up of at least 12 months and were included in the analysis of the long-term follow-up. A long-term response (at least 12 months) was observed in 12/30 (40%). Among the long-term responders, the ACR response was distributed as follows: one patient with ACR90 (last follow-up at month 44+, still depleted in the peripheral blood), 4 patients with ACR70 (response duration at month 44+, +30, 18+, +14, respectively; B-cell recovery present in all), 5 patients with ACR50 (response duration at month +24, +24, 12+, +12, +12, respectively; B-cell recovery present in all), 2 patients with ACR20 (response duration at month +16, +12, respectively; B-cell recovery in all). All long-term responders were rheumatoid factor (RF) positive at baseline; even if a significant mean decrease of RF levels was documented in all the long-term responders, RF persistently disappeared in only 1/12.
Conclusion: A long-term response after rituximab was noticed in a significant proportion of RA patients (40%). This supports a qualitative effect on B-cells and on the immune system of rituximab in this subset. Predictors of long-term response should be investigated for the clinical relevance.
References: 1) DANCER Study Group.The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum 2006; 54(5):1390-400.
Thanks, Lynn. Just had my second series so this is promising news.
Pat
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