Baricitinib Excels Placebo for RA in Second Phase 3 Trial

Eli Lilly and Company and Incyte Corporation have announced significant results against placebo for the oral Janus kinase (JAK) inhibitor baricitinib in a second Phase 3 trial for rheumatoid arthritis (RA). The primary endpoint was ACR20 response after 12 weeks of treatment.

The RA-BUILD study included 684 patients from 20 countries who had moderately to severely active RA and inadequate response or intolerance to at least one conventional disease-modifying antirheumatic drug (cDMARD).

Adverse events were similar to those of placebo.

Baricitinib is a once daily, oral, selective JAK1 and JAK2 inhibitor. It has also proven effective against placebo in the RA-BEACON study, whose results were announced last December.

The JAK inhibitor tofacitinib (Xeljanz), already approved for the treatment of RA, targets JAK-1 and JAK-3, with functional selectivity over JAK-2.

"Today’s announcement includes results from top-line data only," a Lilly representative wrote in response to a question. "More detailed results will be presented at scientific meetings in 2015; however, those have yet to be identified. We hope to submit to various publications as well."