Positive Results from RA Trial

Susan Farley
Published Online: Wednesday, February 1, 2006

A phase 3 clinical study of rituximab (Rituxan) for the treatment of rheumatoid arthritis (RA) showed that patients who received 2 infusions of rituximab along with a stable dose of methotrexate experienced a 20%, 50%, and 70% improvement in the number of swollen and tender joints, as compared with a placebo. These percentages correspond to a standard assessment used by the American College of Rheumatology (ACR) that measures patients' responses to antirheumatic therapies. The 24-week, multicenter, double-blind, placebo-controlled study included 520 patients with active RA who had not responded well to prior treatment with >1 anti-tumor necrosis factor (TNF) therapies. Among those who received rituximab, 51% achieved ACR 20, compared with 18% of placebo patients; 27% achieved ACR 50, compared with 5% in the placebo group; and 12% achieved ACR 70, compared with 1% in the placebo group. The incidence of serious infections was low in both the rituximab and the placebo groups—2% and 1%, respectively. Clinicians are encouraged by this trial, because few options currently exist for RA patients who do not respond to anti-TNF therapy.

Ms. Farley is a freelance medical writer based in Wakefield, RI.

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