Actemra (tocilizumab), a biologic drug being developed to treat rheumatoid arthritis by Roche Pharmaceuticals, has produced successful results in the third Phase III trial conducted. Actemra is a first-in-class humanized anti-interleukin-6 receptor monoclonal antibody. There were 498 patients in the trial known as Actemra RADIATE (Rheumatoid Arthritis Study in Anti-TNF Failures). The RADIATE trial studied Actemra in moderate to severe rheumatoid arthritis patients who failed to respond to anti-tumor necrosis factor treatments (anti-TNF drugs) e.g., Enbrel, Remicade, and Humira.
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Roche announced that a greater proportion of patients treated with Actemra plus methotrexate (4 mg. or 8 mg.) achieved significant reduction in rheumatoid arthritis signs and symptoms as evaluated by ACR20 after 24 weeks of treatment than patients who were treated with placebo plus methotrexate.
The results confirm the findings from previous trials and enforce that interleukin-6 receptor inhibition is effective for reducing inflammation associated with rheumatoid arthritis. The drug was generally well-tolerated with common side effects that included nausea, headache, nasopharyngitis (inflammation of the upper throat), diarrhea, and upper respiratory tract infection. Other phase III trials for Actemra are ongoing and another is expected to report this year as well.
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