ACTEMRA in combination
with MTX is effective in
reducing signs and symptoms
in DMARD-IR patients.
OPTION
tOcilizumab Pivotal Trial in Methotrexate Inadequate respONders
The OPTION trial evaluated 623 patients who had an inadequate clinical response to methotrexate (MTX). Doses of 4 or 8 mg/kg ACTEMRA or placebo were given every 4 weeks, in combination with stable MTX (10 mg to 25 mg weekly).
Summary of results
Compared with controls treated with placebo plus MTX, patients in the ACTEMRA 8 mg/kg plus MTX arm had superior American College of Rheumatology (ACR) 20 (59% vs. 26%), ACR50 (44% vs. 11%) and ACR70 (22% vs. 2%) responses (p<0.0001 for each) and more patients achieved Disease Activity Score (DAS28) remission at 24 weeks (27% vs. 0.8%, p<0.0001). Patients in the ACTEMRA 8 mg/kg plus MTX arm also had greater improvements in C-reactive protein (CRP) levels that appeared within 2 weeks of the first infusion and were maintained throughout the study, as well as improvements in physical function (health assessment questionnaire disability index [HAQ-DI] score) and fatigue (functional assessment of chronic illness therapy fatigue [FACIT-Fatigue] score).
ACTEMRA in combination with MTX was an effective and well-tolerated therapeutic approach in patients with moderate to severe active rheumatoid arthritis (RA) with an inadequate response to MTX.
Reference:
Smolen JS, et al. Lancet 2008; 371: 987-997.