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ACTEMRA (R) (tocilizumab) Significantly Reduced Signs and Symptoms of Rheumatoid Arthritis in Patients Who Failed Prior Treatments
Date:10/25/2008

ard effective dose regimen of methotrexate alone.

In both studies, nearly one-third of all ACTEMRA (8 mg/kg) patients achieved disease remission (as defined by DAS28 <2.6(2)) and ACTEMRA was generally well-tolerated compared with existing therapies.

About the RADIATE Study

RADIATE (RheumAtoiD ArthritIs Study in Anti-TNF FailurEs), a three-arm, randomized, double-blind, placebo-controlled study, was designed to evaluate the safety and efficacy of ACTEMRA plus methotrexate compared with placebo plus methotrexate in patients who failed to adequately respond to anti-TNF-alpha medications alone.? Between 13-17 percent of the study population experienced three or more prior anti-TNF-alpha failures. Patients were randomized to receive either ACTEMRA intravenously (4 mg/kg or 8 mg/kg) plus methotrexate every four weeks or placebo infusions plus methotrexate weekly for 24 weeks. The study included nearly 500 patients from 128 sites in 13 countries, including the United States. In the study, 50 percent, 29 percent and 12 percent of RA patients treated with ACTEMRA 8 mg/kg plus methotrexate achieved ACR20, ACR50 and ACR70, respectively, and 30 percent, 17 percent and 5 percent of patients in the ACTEMRA 4 mg/kg arm achieved these ACR scores, respectively. In contrast, 10 percent, 4 percent and 1 percent of patients in the control group achieved ACR20, ACR50 and ACR70, respectively. Furthermore, disease remission (DAS28 <2.6) was demonstrated in 30 percent and 8 percent of patients treated with ACTEMRA 8 mg/kg and 4 mg/kg, respectively, compared with 1.6 percent of patients in the control group.

Treatment with ACTEMRA and methotrexate showed significant clinical benefits even in the subgroup analysis of difficult-to-treat patients who received up to three anti-TNF-alpha therapies that failed.

The most common adverse reactions reported most frequently in the ACTEMRA arms of the RADIATE study were diarrhea, upper abdominal pain, rash and dizzine
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SOURCE Hoffmann-La Roche Inc.
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