ARTICLE | Clinical News

Actemra: Phase III data

November 22, 2010 8:00 AM UTC

The double-blind, U.S. Phase III ROSE trial in 619 patients with an inadequate response to DMARD therapy showed that 8mg/kg Actemra every 4 weeks plus DMARDs met the primary endpoint of significantly improving ACR50 response rate at week 24 vs. placebo (30.1% vs. 11.2%, p<0.0001). Actemra also significantly reduced mean DAS28 score from baseline to week 24 vs. placebo (3.29 vs. 1.37, p<0.0001). At week 4, 34.2%, 12.5% and 4.4% of patients receiving Actemra achieved an ACR20, ACR50 and ACR70 response, respectively, vs. 17.6%, 3.4% and 1.5% for placebo (p<0.0001, p=0.0002 and p=0.0627). Additionally, ACR20 and ACR70 response rates were significantly higher for Actemra vs. placebo at week 24 (44.7% and 15.4%, respectively, vs. 25.4% and 1.5%, p<0.0001 for both). Data were presented at the American College of Rheumatology Meeting in Atlanta. ...