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Actemra (tocilizumab) Significantly Improves Symptoms of Rheumatoid,Arthritis Compared to a Current Standard of Care

e. Patients received ACTEMRA(TM) intravenously (either 4mg/kg or 8mg/kg) every 4 weeks plus methotrexate weekly, or placebo infusions plus methotrexate weekly, for 24 weeks. The study enrolled patients at 73 trial sites in 17 countries outside the United States, and is one of five Phase III trials designed to study ACTEMRA(TM) as a potential new treatment for RA.

Data from the study were analyzed to determine patients' response to treatment by using three standard assessments: ACR score(1), developed by the of Rheumatology (ACR), DAS28(2), a measurement of RA disease activity, and EULAR(3), a measurement of treatment response.

In the study, 43.9% of patients treated with ACTEMRA(TM) (8mg/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. At 24 weeks, disease remission, as measured by DAS28 (<2.6), was achieved by 28% of patients treated with ACTEMRA(TM) 8mg/kg plus methotrexate compared to 1% of those in the placebo and methotrexate group. At 24 weeks, the difference in the reduction of DAS28 from baseline was greater and statistically significant (p<0.0001) in patients treated with ACTEMRA(TM) 8mg/kg plus methotrexate (-3.43) compared to those in the placebo and methotrexate group (-1.55). According to the EULAR response, a good/moderate response was seen in 79.5% and 61.9% of patients receiving ACTEMRA(TM) plus methotrexate 8mg/kg and 4mg/kg, respectively, compared to 34.8% of patients receiving placebo plus methotrexate.

About ACTEMRA(TM) (tocilizumab)

ACTEMRA(TM) is the first humanized interleukin-6 (IL-6) receptor- inhibiting monoclonal antibody studied for the treatment of RA. Roche and Chugai have initiated a collaborative Phase III clinical development program in RA that is underway outside Japan with more than 4,000 patients have been recruited in 41 countries
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