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Baricitinib meets primary endpoint in RA phase 3 trial

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Eli Lilly and Co. and Incyte Corp. announced that baricitinib has met its primary endpoint of improved American College of Rheumatology 20 response compared with placebo after 12 weeks in the RA-BEACON study.

The 6-month, phase 3 study enrolled 527 rheumatoid arthritis patients with moderate-to-severe symptoms who failed at least one anti-tumor necrosis factor (TNF) therapy previously. Participants were treated with one or two daily doses of baricitinib — an oral, selective JAK1 and JAK2 inhibitor — in addition to concurrent doses of conventional disease-modifying anti-rheumatic drugs (DMARDs).

“People with rheumatoid arthritis who have had an inadequate response to TNF inhibitors are generally considered to be the least responsive to subsequent treatments,” David Ricks, Eli Lilly senior vice president and president of Lilly Bio-Medicines, said in a company press release. “These results give us further confidence in the potential for baricitinib to be a meaningful treatment option for those suffering from this debilitating condition.”

Adverse events were similar to those seen with placebo, and no opportunistic infections or gastrointestinal perforations were observed, according to the release. Treatment-emergent adverse events included headache, upper respiratory tract infections and nasopharyngitis.

The companies reported that a large number of enrollees are participating in a long-term extension of the study, and additional study data from the RA-BEACON study — including data from more than 3,000 participants — are expected to be released at scientific meetings in 2015.