Biogen Idec and Genentech seek approval for Rituxan in arthritis

The submission is based primarily on the 24-week results of a multi-center, phase III study. In the trial, patients who received a single course of two infusions of Rituxan with a stable dose of methotrexate (MTX) displayed a statistically significant improvement in symptoms measured at 24 weeks, compared to those receiving placebo and MTX.
“Rituxan may provide a potential new treatment approach for the RA (rheumatoid arthritis) patient population with the greatest unmet medical need,” said Dr Hal Barron, Genentech’s senior vice president, development and chief medical officer. “This submission marks an important milestone in our ongoing efforts to develop novel therapies for B-cell-mediated diseases.”

The most common side effects in the Rituxan arm of the study included headache, upper respiratory tract infection and nasopharyngitis. The reported rate of serious adverse events was comparable across treatment arms.

Rheumatoid arthritis is a debilitating autoimmune disease that affects more than two million Americans and hinders the daily activities of sufferers. The disease occurs when the immune system inappropriately attacks joint tissue, causing painful chronic inflammation and irreversible destruction of cartilage, tendons and bones, often resulting in disability.