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Eli Lilly Announces Positive End Result for Baricitinib RA Phase 3 Study
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Eli Lilly and Co. announced results from the RA-BEACON phase 3 trial of baricitinib for the treatment of rheumatoid arthritis, and that baricitinib met its primary endpoint of an American College of Rheumatology 20 response rate higher than placebo at 12 weeks, according to a company press release.
Besides background therapies, with 4 mg baricitinib, 55% of patients with rheumatoid arthritis (RA) achieved an American College of Rheumatology (ACR) 20 response, and 49% of patients who received 2 mg baricitinib met an ACR20 response vs. 27% of patients with RA who received a placebo.
The study included 527 patients who previously had an inadequate response to tumor necrosis factor inhibitors.
“The findings from the RA-BEACON study suggest treatment with baricitinib is associated with meaningful improvements in RA symptoms,” Terence Rooney, MD, Lilly's senior medical director for baricitinib, said in the release. “The baricitinib clinical development program includes a wide range of patients across the RA treatment spectrum. If approved, baricitinib may be a valuable option for rheumatologists and patients who are looking for new alternatives to treat this debilitating disease.”
According to the release, ACR50 and ACR70 response rates also were significantly higher for patients who received baricitinib, a once-daily Janus kinase (JAK) 1 and JAK2 inhibitor, compared with placebo at week 12.
Adverse events accounted for 6% of discontinuation of treatment with 4 mg baricitinib, and 4% each for 2 mg baricitinib and placebo. Common adverse events included nasopharyngitis, headache and upper respiratory tract infections.
Baricitinib is currently being evaluated in phase 2 trials for patients with systemic lupus erythematosus and atopic dermatitis.
Reference: www.lilly.com