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Roche: Actemra Phase III Study Shows Benefits In RA March, 2008

Swiss drugmaker Roche Holding AG (RHHBY) said Tuesday that new data from a phase III study on Actemra, published in this week's issue of The Lancet, shows that patients with rheumatoid arthritis treated with Actemra experienced a rapid and significant reduction in the signs and ymptoms of their disease.

Results from the OPTION trial - a major Phase III international study - demonstrated that rheumatoid arthritis patients not only achieved greater improvement of symptoms but also a higher quality-of-life with ACTEMRA, an innovative interleukin-6 receptor inhibitor, compared with methotrexate, a commonly used RA treatment.

"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 and stiffness, physical disability and fatigue despite treatment with existing therapies."

Rheumatoid arthritis is a progressive autoimmune disease characterized by inflammation of the membrane lining in the joints throughout the body. This inflammation causes distortion of the joint and impaired function accompanied by pain, stiffness and swelling and ultimately leading to irreversible joint destruction and disability. In addition, the systemic symptoms of RA include fatigue, anaemia, osteoporosis and may contribute to shortening life expectancy by affecting major organ systems. Sadly after 10 years, less than 50% of patients can continue to work or function normally on a daily basis.

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and it represents a novel mechanism of action to treat RA. Research has shown that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, reduces inflammation of the joints and relieves certain systemic effects of RA.

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) , compared with 26.5% of patients in placebo plus metrotrexate patients. In the study, 43.9% of patients treated with ACTEMRA (8 mg/kg) plus methotrexate 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) was seen as early as two weeks in a greater proportion of patients treated with ACTEMRA plus methotrexate, with 27.5% achieving clinical remission (DAS28= 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 , compared with 35% for those treated with placebo and methotrexate at 24 weeks. 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.

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