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ACTEMRA(R) (tocilizumab) Significantly Reduces Rheumatoid Arthritis Signs and Symptoms Regardless of Previous Therapy in Two New Global Studies
Date:6/13/2008

gned 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 medications alone. Between 12-18 percent of the study population experienced three or more prior anti-TNF 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 499 patients from 128 trial 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, compared with 10 percent, 4 percent and 1 percent, respectively, of patients treated with placebo infusions plus methotrexate weekly.

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-TNFs therapies that failed. Furthermore, disease remission (DAS28 <2.6) was demonstrated in 30 percent of ACTEMRA patients compared with 1.6 percent of patients in the control group.

The most common adverse reactions reported more frequently in the ACTEMRA arms of the RADIATE trial were nausea, headache, nasopharyngitis, diarrhea, and upper respiratory tract infections.

"These study results are very promising for RA patients who need a variety of treatment options, particularly when they have failed to achieve adequate pain and symptom relief with anti-TNF therapies," said Professor Paul Emery, lead study investigator of the RADIATE trial and Professor of Rheumatology, University of Leeds in the United Kingdom.

In both studies, patients treated with ACTEMRA alone or with methotrexate achieved greater improvements in quality-of-life measures, including fatigue, pain, and physical and mental functions, compared with methotrex
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SOURCE Roche
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