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Actemra (tocilizumab) Third Phase III Study Results Show,Significant Improvement in Symptoms of Patients with Rheumatoid,Arthritis

- Multinational Phase III Study Meets Primary Endpoint in Rheumatoid Arthritis Patients Who Failed to Respond to Anti-tumor Necrosis Factor Treatments -

NUTLEY, N.J., July 10, 2007 /PRNewswire/ -- Roche today announced that results from the Actemra Radiate (RheumAtoiD ArthritIs Study in Anti-TNF FailurEs) trial successfully met its primary endpoint in patients with moderate to severe rheumatoid arthritis (RA) who failed to respond to anti-tumor necrosis factor treatments (anti-TNFs).

The trial - the third multinational Phase III study of ACTEMRA outside of Japan - showed that a greater proportion of patients treated with ACTEMRA plus methotrexate (4 mg/kg or 8 mg/kg) achieved a significant reduction in the signs and symptoms of RA as evaluated by ACR20 following 24 weeks of treatment, compared to those who were treated with placebo plus methotrexate.

ACTEMRA was generally well tolerated; the most common adverse events reported more frequently in the ACTEMRA arms of the RADIATE trial were nausea, headache, nasopharyngitis, diarrhea and upper respiratory tract infection.

"The study results reconfirm the findings from the previous multinational trials that interleukin-6 receptor inhibition is a novel mechanism for reducing inflammation caused by RA," said Lars Birgerson, M.D., Ph.D., Global Head Medical Affairs, Roche. "The data demonstrate that ACTEMRA can potentially offer an effective approach in reducing the signs and symptoms of RA, particularly when therapies such as anti-TNFs prove insufficient."

Data from this trial will be submitted for presentation at upcoming national scientific meetings. In addition, other Phase III trials exploring ACTEMRA in RA are ongoing with another study scheduled to report in 2007.

About the RADIATE Study

The RADIATE (RheumAtoiD ArthritIs Study in Anti-TNF FailurEs) study is a three-arm, randomized, double-blind, placebo-controlled study
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