ROCHE ANNOUNCES RESULTS OF RA STUDY

Roche has announced the OPTION trial, the first international Phase III study of Actemra outside of Japan, successfully met its primary endpoint in patients with moderate to severe rheumatoid arthritis (RA) who had an inadequate response to methotrexate, a current standard of care. The study showed that a greater proportion of RA patients treated with Actemra (either 4 or 8 mg/kg) plus methotrexate achieved a significant improvement in disease signs and symptoms at week 24 compared with placebo plus methotrexate.

In the three-arm, randomized, double-blind, controlled study, patients received Actemra intravenously every four weeks plus methotrexate weekly or placebo infusions plus methotrexate weekly. Patient response was measured using a standard assessment developed by the American College of Rheumatology to measure the signs and symptoms of RA. A 20 percent reduction in the signs and symptoms of RA is represented as ACR20. The study enrolled 623 patients at 73 trial sites in 17 countries outside the U.S.

The OPTION study is one of five Phase III trials under way to study Actemra as a potential new treatment for RA. Roche and Chugai have initiated the collaborative clinical development program that has enrolled a total of more than 4,000 patients in 41 countries including the U.S. and several European countries.

Actemra is the first humanized interleukin-6 (IL-6) receptor-blocking monoclonal antibody with a novel mechanism of action. 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, prevent long-term damage and relieve certain systemic effects of RA such as anemia, fatigue and osteoporosis.