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Tocilizumab (Actemra), Roche Pharmaceuticals' drug to treat patients with moderate-to-severe rheumatoid arthritis (RA), met its primary end points when administered to RA patients who did not have significant response to methotrexate. The trial, known as OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders), was a 3-arm, randomized, double-blind controlled study that evaluated the safety and efficacy of tocilizumab plus methotrexate, compared with placebo plus methotrexate.
Patients in the tocilizumab group received either 4 mg/kg or 8 mg/kg intravenously every 4 weeks plus a weekly dose of methotrexate. Patients in the control group received placebo infusions plus methotrexate weekly. Researchers determined efficacy by measuring patient response on a standard assessment from the American College of Rheumatology (ACR). When compared with patients in the placebo group, patients in the tocilizumab group experienced a 20% reduction in the signs and symptoms of their RA, as demonstrated by their ACR scores.
Lars Birgerson, MD, PhD, Roche's vice president of medical affairs, reported, "Through its unique blockade of the interleukin-6 receptor, tocilizumab may offer a novel approach to reduce the debilitating symptoms of RA and help patients who may not be achieving sufficient relief from standard therapies like methotrexate."
Ms. Farley is a freelance medical writer based in Wakefield, RI.