Baricitinib superior to methotrexate in treatment of patients with RA

Eli Lilly and Company and Incyte Corporation announced positive results from a phase 3 trial evaluating baricitinib against methotrexate to treat patients with rheumatoid arthritis, according to a company press release.

A cohort of 600 patients with rheumatoid arthritis (RA) who had limited or no previous treatment with disease-modifying anti-rheumatic drugs (DMARDS) were enrolled as part of a larger cohort of over 3,000 patients with RA. The 600 patients were randomized 1:1:1 to either monotherapy oral methotrexate once a week, monotherapy with 4-mg baricitinib once daily or a combination of 4-mg baricitinib daily and oral methotrexate once weekly. Based on response to treatment after 24 weeks, the study met its primary endpoint of noninferiority of baricitinib, a Janus kinase-1 (JAK1) and JAK2 cytokine inhibitor, compared to methotrexate.

“The superiority of baricitinib over methotrexate in the treatment of patients with early RA adds to the positive data already seen for baricitinib in RA patients with inadequate responses to traditional DMARDs (RA-BUILD) and biological therapies (RA-BEACON),” Rich Levy, MD, chief drug development officer of Incyte, said in the release. “The sum of these results further illustrates the therapeutic profile of baricitinib. If approved, we believe that baricitinib has the potential to be used across multiple lines of therapy in rheumatoid arthritis.”

In addition to ongoing phase 3 testing as a treatment for RA, baricitinib is currently in phase 2 development for treatment of patients with psoriasis and diabetic neuropathy.

Reference: www.lilly.com.