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B-Cell Biologic Therapy Could Revolutionize Rheumatoid Arthritis Treatment

0 mg. dose of rituximab--two infusions two weeks apart--with either intravenous steroid, oral steroid, or placebo. Three groups received a placebo with either intravenous steroid, oral steroid, or another placebo. All subjects received the DMARD methotrexate (MXT). All subjects were evaluated every four weeks for changes in the Disease Active Score (DAS), a 28-joint assessment for swelling and tenderness, as well as for overall disease improvement, with the goal of meeting the American College of Rheumatology (ACR) 20 percent improvement criteria.

At the 24-week culmination, 54 percent of the subjects in three rituximab 1,000 mg. X 2 groups and 55 percent of the subjects in the three rituximab 500 mg. X 2 groups had achieved the desired ACR20 response, compared with 28 percent of the subjects in the three placebo groups. The different dosages of rituximab did not have a statistically significant impact on the odds of achieving an ACR20 response, and analyses of the proportions of patients who achieved higher ACR improvement scores--50 percent and 70 percent--showed similar patterns. Changes in DAS28 at week 24 reflected the ACR response findings, as did the subjects reports of relief from joint pain and stiffness. What's more, subjects in the rituximab groups showed gains toward disease remission earlier in the course of treatment than subjects in the placebo group.

Steroids, whether received intravenously or orally, showed no significant correlation with disease improvement scores among the rituximab groups. Intravenous steroid, however, showed a positive correlation to improved tolerability during the first rituximab infusion in both dosage groups. Overall, adverse events associated with rituximab were mild and easily managed. Headache was the most common complaint.

Confirming the role of B cells in the inflammatory processes behind RA, this study demonstrates the effectiveness and safety of a unique biologic therapy, in moderat
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