Biogen, Genentech announce positive results in Rituxan study

SAN FRANCISCO & CAMBRIDGE, Mass. Biogen and Genentech have released the results of a Phase III clinical study of the arthritis drug Rituxan. The drug’s results were compared with a placebo study and, according to the American College of Rheumatology 20, scored significantly higher at six months than did the placebo. Both studies involved using the drug methotrexate in combination with the Rituxan and the placebo. The ACR 20 measures an improvement in arthritis on a scale of improvement by 20 percent or more.

In this study, titled SERENE, patients received a single treatment of two infusions of either 500 mg or 1000 mg of Rituxan in combination with a stable dose of methotrexate. Although the study was not designed to compare the Rituxan doses, treatment efficacy appears to be similar between both Rituxan doses. Further analyses of the data are ongoing and will be submitted for presentation at an upcoming medical meeting.

“While use of Rituxan with methotrexate is well-established in rheumatoid arthritis patients who have had an inadequate response to anti-TNF therapy, this is the first Phase III study demonstrating that Rituxan improved symptoms of rheumatoid arthritis in patients who had not previously been treated with a biologic therapy,” said Hal Barron, M.D., Genentech’s senior vice president, development and chief medical officer. “These findings support the potential use of Rituxan earlier in the course of treatment for this debilitating disease.”