FDA Approves New JAK Inhibitor for Active RA

June 5, 2018

The FDA recently approved the 2 mg dose of baricitinib (Olumiant) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) unresponsive to 1 or more tumor necrosis factor inhibitors.

Baricitinib is a once-daily oral medication that can be administered as a monotherapy or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDS). The use of baricitinib in combination with janus kinase inhibitors or biologic DMARDS or potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.
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Approval was based on results from a randomized, double-blind, placebo-controlled study that included 527 participants with RA who were randomized to 2 mg or 4 mg of baricitinib or placebo in addition to their current DMARD therapy. Baricitinib was associated with significantly higher response rates on the American College of Rheumatology Criteria (ACR20) at week 12, as well as improvements on individual ACR20 component scores. In addition, participants experienced early relief of symptoms, which was seen as early as week 1.

The most common adverse events included upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.

Baricitinib was approved with a boxed warning for the risk of serious infections, malignancies and thrombosis. Other warnings and precautions include gastrointestinal perforations, laboratory abnormalities, and a warning against the use of live vaccines while receiving treatment with baricitinib.


FDA approves Olumiant (baricitinib) 2-mg tablets for the treatment of adults with moderately-to-severely active rheumatoid arthritis [press release]. Indianapolis, IN: Eli Lilly and Company; June 1, 2018. https://investor.lilly.com/news-releases/news-release-details/fda-approves-olumiantr-baricitinib-2-mg-tablets-treatment-adults. Accessed June 5, 2018.