Patients on rituximab achieve ACR 20 response

Biotechnology major Genentech and fellow USA-based Biogen Idec say that a Phase III clinical study of Rituxan (rituximab) in biologic-naive patients met its primary endpoint of a significantly greater proportion of Rituxan-treated patients achieving an American College of Rheumatology 20 response at week 24, compared to placebo.

The SERENE study enrolled patients with moderately-to-severely active rheumatoid arthritis who had an inadequate response to prior treatment with methotrexate, a disease modifying anti-rheumatic drug. Although the trial was not designed to compare the Rituxan doses, treatment efficacy appears to be similar between both strengths of the agent, the firm noted, adding that further analyses of the data are ongoing and will be submitted for presentation at an upcoming medical meeting.

"While use of Rituxan with MTX is well-established in RA patients who have had an inadequate response to anti-TNF therapy, this is the first Phase III study demonstrating that Rituxan improved symptoms of RA in patients who had not previously been treated with a biologic therapy," said Hal Barron, chief medical officer of the firm, which is majority-owned by Swiss drug major Roche. "These findings support the potential use of Rituxan earlier in the course of treatment for this debilitating disease," he added.