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The OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) trial, the first international phase III study of tocilizumab (Actema) outside of Japan, has successfully met its primary endpoint in patients with moderate to severe rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX).
This three-arm, randomised, double-blind, controlled trial was designed to evaluate the safety and efficacy of tocilizumab plus MTX compared with placebo plus MTX in patients with RA who had an inadequate response to MTX alone. Patients were given tocilizumab IV (4 or 8mg/kg) every four weeks plus MTX weekly or placebo infusions plus MTX weekly, with their response measured using the American College of Rheumatology (ACR) classification. The study enrolled 623 patients at 73 trial centres in 17 countries outside of the USA.
A greater proportion of patients treated with tocilizumab + MTX achieved a significant improvement in disease signs and symptoms (ACR 20) at week 24, compared with placebo + MTX. The preliminary analysis also demonstrated that the safety profile of tocilizumab was consistent with earlier development studies, with the most common side-effects being upper respiratory tract infection and headache.