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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

f patients in the placebo arm (p<0.0001) at 24 weeks. Data from the two studies showed that more than half of patients experienced at least a 20% reduction in RA symptoms (ACR20) in the ACTEMRA plus DMARD therapies groups compared to the placebo plus DMARD therapies groups. ACTEMRA was generally well tolerated in both studies; the most common adverse events reported more frequently in the ACTEMRA arm were upper respiratory tract infections, headache, nasopharyngitis, and hypertension.

"It is vital that physicians have a variety of treatment options to offer patients to treat this debilitating and chronic disease," said Josef Smolen, M.D., lead investigator of the OPTION trial and Professor of Medicine at the University Clinic for Internal Medicine in Vienna, Austria. "ACTEMRA may offer a novel approach to help patients who may not be achieving sufficient relief from standard therapies like methotrexate."

About TOWARD Study

The TOWARD trial, a two-arm, double-blind, placebo controlled study, was designed to evaluate the safety and efficacy of ACTEMRA plus DMARDs compared to placebo plus DMARDs in RA patients. Patients were randomized to receive either ACTEMRA intravenously (8mg/kg) every four weeks plus DMARDs weekly or placebo infusions plus DMARDs weekly. The study treated 1,216 patients at 130 trial sites in 18 countries, including the United States.

About OPTION Study

In the OPTION trial, 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. OPTION, a three-arm, double-blind, controlled study, evaluated the safety and efficacy of ACTEMRA plus methotrexate compared to placebo plus methotrexate in RA patients. The study was conducted in 73 trial sites in 17 countries outside the United States.

Study Results

Both TOWARD and OPTION studies showed that at 24 weeks significantly more patients achieved a 20%
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SOURCE Roche
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