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Two Pivotal Phase III Studies for Roche's ACTEMRA(TM) (tocilizumab) Demonstrate Significant Improvement in Rheumatoid Arthritis Symptoms
Date:11/7/2007

, 50% and 70% (ACR20, ACR50 and ACR70) reduction of symptoms with ACTEMRA plus DMARD therapies compared to the control group. In the TOWARD trial, ACR20, ACR50 and ACR70 was achieved in 61%, 38% and 21%, respectively, of ACTEMRA plus DMARDs patients versus 25%, 9% and 3%, respectively, in the placebo plus DMARDs arm. In the OPTION trial, 59%, 44% and 22%, respectively, of patients treated with ACTEMRA (8mg/kg) plus methotrexate achieved ACR20, ACR50 and ACR70 compared with 27%, 11% and 2%, respectively, in the placebo plus methotrexate control arm.

"We are excited to announce these results as they indicate that ACTEMRA and its unique IL-6 inhibition may become a significant new treatment option for people suffering from RA," said Lars Birgerson, M.D., Ph.D, Vice President, Global Head Medical Affairs, Roche. "Findings from these studies will be part of the application to the U.S. Food and Drug Administration that we intend to submit by year's end."

In the TOWARD trial, disease remission was demonstrated in 30% of ACTEMRA patients (DAS28 <2.6) compared with 3.4% of patients treated with only DMARDs. In the OPTION trial disease remission was demonstrated in 28% of ACTEMRA patients (DAS28 <2.6) compared with 1% of patients treated with methotrexate alone. In both studies, levels of C-reactive protein (CRP), a marker of inflammation, and hemoglobin levels, showed an improvement within two weeks and remained at normal levels through the end of both studies. According to both studies, patients treated with ACTEMRA plus anti-rheumatic therapies experienced greater improvements in quality of life and function measures, including fatigue, physical and mental functions compared to placebo plus anti-rheumatic treatments.

Other Studies

The TOWARD and OPTION trials are part of a large clinical development program that enrolled more than 4,000 RA patients in 41 countries, including the United States and several European countries. Two others, RADIATE (Rese
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