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Title: Rheumatoid Arthritis Symptoms Appear Significantly Improved with Rituximab Therapy

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N Engl J Med 2004;350:2572-81
06/21/2004 11:21:00 AM
By Joene Hendry

Symptoms of rheumatoid arthritis appear to significantly improve with the addition of rituximab therapy, according to the findings of a randomised, double-blind, controlled trial conducted in Australia, Canada, Israel, and 8 European countries. "A single short course of rituximab (2 infusions, on days 1 and 15), either alone or in combination with cyclophosphamide or continuing methotrexate, provided patients with significant improvements in disease symptoms," writes Jonathan C. W. Edwards, MD, Centre for Rheumatology, University College London, United Kingdom, and colleagues. The researchers assessed clinical response according the American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) at 24 weeks in 161 patients randomised to 1 of 4 treatment groups: methotrexate; rituximab alone; rituximab plus intravenous infusion of 750 mg cyclophosphamide on days 3 and 17; or rituximab plus methotrexate. Rituximab treatment consisted of a 1000 mg intravenous infusion on days 1 and 15, while methotrexate treatment consisted of 10 mg or more orally per week. Patients received the appropriate placebos to mask their therapy group, and additionally received corticosteroids, leucovorin calcium, and an antiemetic agent. At week 24, 43% of the patients treated with rituximab and methotrexate ([P = .005), 41% of those treated with rituximab and cyclophosphamide (P = .005), and 33% of those treated with rituximab alone (P = .059) achieved an ACR 50 response, indicating a 50% improvement in disease symptoms. Of the patients treated with methotrexate alone, 13% achieved ACR 50. A response of ACR 20 was achieved by 73%, 76%, and 65% of the rituximab plus methotrexate, rituximab plus cyclophosphamide, and rituximab alone groups, compared with 38% of those treated with methotrexate alone at 24 weeks, and a response of ACR 70 was achieved in 23%, 15%, 15%, and 5% of the groups, respectively. A higher percentage of patients in the rituximab plus methotrexate group maintained ACR response at 48 weeks than those in the other treatment groups. From 83% to 85% of the 3 groups treated with rituximab compared with 50% of those treated with methotrexate alone achieved moderate or good EULAR response. Serious adverse events occurred in 8%, 15%, 5%, and 8%, respectively, in the rituximab plus methotrexate, the rituximab plus cyclophosphamide, the rituximab alone, and the methotrexate alone groups, while any adverse event occurred in 85%, 73%, 80%, and 80%, respectively, at week 24. Overall, 2.5% of the methotrexate group compared with 3.3% of the patients treated with rituximab developed serious infections. "The incidence of infection will require careful monitoring in future studies," the authors note. "This study provides clear evidence that a single short course of rituximab provides significant, clinically meaningful benefits to patients with active rheumatoid arthritis," the authors conclude.

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