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International ACTEMRA Rheumatoid Arthritis Study Highlighted in The Lancet
Date:3/20/2008

otrexate achieved at least a 50% (ACR50) reduction in symptoms compared to 10.8% of patients receiving placebo and methotrexate; ACR70 was achieved in 22% of the treatment group versus 2% in the control group. A rapid decrease in disease activity (DAS28)(2) was seen as early as two weeks in a greater proportion of patients treated with ACTEMRA plus methotrexate, with 27.5% achieving DAS28 less than or equal to 2.6 by 24 weeks.

Additionally, results showed that 80% of patients in the ACTEMRA (8mg/kg) plus methotrexate group responded with moderate to good improvements in RA symptoms, according to the EULAR response criteria(3), compared with 35% for those treated with placebo and methotrexate at 24 weeks. ACTEMRA was generally well tolerated; the most common adverse events reported more frequently in the ACTEMRA arms of the OPTION trial were upper respiratory tract infection, nasopharyngitis and headache.

The OPTION trial also assessed physical function and quality-of-life at baseline and every four weeks thereafter. Patients receiving ACTEMRA achieved significantly greater improvement in areas of fatigue and mental function at 24 weeks, and achieved normal levels of hemoglobin and C-reactive protein (CRP), a marker of inflammation due to RA, compared with patients receiving placebo plus methotrexate.

"We are very encouraged by the findings of the study as they further establish the role of ACTEMRA and its unique blockade of IL-6 receptors as a potential new biologic treatment option for patients with RA," said Lars Birgerson, M.D., Ph.D, Vice President, Global Head Medical Affairs, Roche.

About ACTEMRA(TM) (tocilizumab)

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting 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 certain systemic effects of RA. The extensive clinical
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SOURCE Roche
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