BioCentury
ARTICLE | Clinical News

VX-509: Phase IIb data

October 28, 2013 7:00 AM UTC

A double-blind, international Phase IIb trial in 358 patients with active RA who had an inadequate response to methotrexate showed that all 4 doses of VX-509 plus methotrexate for 24 weeks met the co-primary endpoints of improving ACR20 response rate and DAS28 score from baseline to week 12 vs. placebo. Specifically, ACR20 response rates at week 12 were 46.5% at the once-daily 100 mg VX-509 dose, 66.7% at the once-daily 150 mg VX-509 dose, 58.3% at the once-daily 200 mg VX-509 dose and 68.1% at the twice-daily 100 mg VX-509 dose vs. 18.3% for placebo (p<0.001 for all). Additionally, DAS28 scores were reduced from baseline to week 12 by 2.04 points at the once-daily 100 mg VX-509 dose, 2.2 points at the once-daily 150 mg VX-509 dose, 2.51 points at the once-daily 200 mg VX-509 dose and 2.42 points at the twice-daily 100 mg VX-509 dose vs. 0.7 points for placebo (p<0.001 for all). ...