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 four 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 (DAS) 28 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 CRP levels that appeared within 2 Weeks from 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 therapeutic approach in patients with moderate to severe active RA with an inadequate response to MTX.
Smolen JS, et al. Lancet 2008; 371:987-997.
- © 2012 Roche Hong Kong Limited
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