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news.Roche has said that results from the first phase III study of Actemra successfully met its primary endpoint in patients with moderate to severe rheumatoid arthritis.
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The drug was tested in rheumatoid arthritis (RA) patients who had an inadequate response to methotrexate, a current standard of care.
The study showed that a greater proportion of rheumatoid arthritis patients treated with Actemra plus methotrexate achieved a significant improvement in disease signs and symptoms, at week 24 compared with placebo plus methotrexate. The preliminary analysis demonstrated that the safety profile of Actemra was consistent with earlier development studies.
Actemra is a humanized interleukin-6 (IL-6) receptor-blocking monoclonal antibody. Studies suggest that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, may reduce inflammation of the joints and relieve other effects of RA.
In addition, four other phase III trials exploring Actemra in RA are ongoing with three of them scheduled to report in 2007.