ARTICLE | Clinical News

Cimzia certolizumab pegol: Phase III data

July 20, 2015 7:00 AM UTC

Top-line data from the double-blind, international Phase III C-EARLY trial in 868 evaluable DMARD-naive patients with early, active RA showed that subcutaneous Cimzia plus methotrexate led to a significantly greater rate of sustained remission at week 52 vs. placebo plus methotrexate (28.9% vs. 15%, p<0.001). Additionally, 43.8% of patients receiving Cimzia plus methotrexate had sustained low disease activity at week 52 vs. 28.6% of patients receiving placebo plus methotrexate (p<0.001). Cimzia plus methotrexate also significantly improved inhibition of structural damage as measured by modified total sharp score (mTSS) vs. placebo plus methotrexate (0.2 vs. 1.9 points, p<0.001). Furthermore, Cimzia plus methotrexate reduced HAQ-DI scores by 1 point vs. a 0.8 point increase for placebo plus methotrexate (p<0.001). Data were presented at the European League Against Rheumatism meeting in Rome. ...