Eli Lilly and Co. (LLY) and Incyte Corp. (INCY) Wednesday said the pivotal phase 3 study of baricitinib was published in the New England Journal of Medicine. The compound is currently under regulatory review for the treatment of moderate-to-severe rheumatoid arthritis.
The company said the study met its primary endpoint of improved ACR 20 response for baricitinib compared with placebo at week 12. ACR 20 represents at least a 20 percent improvement across selected measures of disease activity.
The study enrolled 527 patients who previously had failed at least one tumor necrosis factor or TNF inhibitor and included 199 patients who also had received prior treatment with one or more non-anti-TNF biologic agents. Patients received baricitinib 2 mg or 4 mg or placebo daily, in addition to their existing background therapies, for 24 weeks.
by RTT Staff Writer