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

- By targeting interleukin-6 receptors, ACTEMRA provides significant

benefits for patients when compared with existing therapies -

NUTLEY, N.J., March 20 /PRNewswire/ -- Patients with rheumatoid arthritis treated with Roche's ACTEMRA(TM) (tocilizumab) experienced significant and rapid reduction in the signs and symptoms of their disease, according to a study published in this week's issue of The Lancet. Results from the OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) trial -- a Phase III international study -- demonstrated that RA patients achieved greater improvement of symptoms and a higher quality-of-life with ACTEMRA, an interleukin-6 (IL-6) receptor inhibitor, in combination with methotrexate, compared with methotrexate plus placebo.

"Results of this pivotal study convincingly demonstrate that tocilizumab can effectively and rapidly diminish the painful and debilitating effects of rheumatoid arthritis," said Josef Smolen, M.D., lead investigator of the OPTION trial and Professor of Medicine at the Department of Internal Medicine at the Medical University of Vienna, Austria. "These trial findings are significant because we know that many rheumatoid arthritis patients continue to experience symptoms of joint pain, stiffness, physical disability and fatigue, despite treatment with existing therapies."

About OPTION Study

In the OPTION trial, a three-arm, double-blind, controlled Phase III study, 623 patients were randomized to receive ACTEMRA intravenously (either 4mg/kg or 8mg/kg) every four weeks plus methotrexate weekly or placebo infusions plus methotrexate weekly. The study was conducted in 73 trial sites in 17 countries outside the United States.

At 24 weeks, 58.5% of ACTEMRA patients (8mg/kg) achieved a 20% reduction in RA symptoms (ACR20)(1), compared with 26.5% of patients in placebo plus methotrexate patients. In the study, 43.9% of patients treated with ACTEMRA (8mg/kg) plus meth
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SOURCE Roche
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