Tocilizumab (Actemra), Roche Pharmaceuticals'drug to treat patients withmoderate-to-severe rheumatoid arthritis(RA), met its primary end pointswhen administered to RA patients whodid not have significant response tomethotrexate. The trial, known asOPTION (TOcilizumab Pivotal Trial inMethotrexate Inadequate respONders),was a 3-arm, randomized, double-blindcontrolled study that evaluated thesafety and efficacy of tocilizumab plusmethotrexate, compared with placeboplus methotrexate.
Patients in the tocilizumab group receivedeither 4 mg/kg or 8 mg/kg intravenouslyevery 4 weeks plus aweekly dose of methotrexate. Patientsin the control group received placeboinfusions plus methotrexate weekly.Researchers determined efficacy bymeasuring patient response on a standardassessment from the AmericanCollege of Rheumatology (ACR). Whencompared with patients in the placebogroup, patients in the tocilizumabgroup experienced a 20% reduction inthe signs and symptoms of their RA, asdemonstrated by their ACR scores.
Lars Birgerson, MD, PhD, Roche'svice president of medical affairs,reported, "Through its unique blockadeof the interleukin-6 receptor, tocilizumabmay offer a novel approach toreduce the debilitating symptoms ofRA and help patients who may not beachieving sufficient relief from standardtherapies like methotrexate."
Ms. Farley is a freelance medicalwriter based in Wakefield, RI.