Baricitinib Approved for Adult Patients With Severe Alopecia Areata

The US Food and Drug Administration recently announced approval of baricitinib oral tablets to treat adult patients with severe alopecia areata (AA).

The first systemic treatment approved for AA, baricitinib is a Janus kinase (JAK) inhibitor that interferes with the pathway leading to inflammation by blocking the activity of one or more specific enzymes. It is indicated for severe AA in addition to moderate to severe active rheumatoid arthritis and COVID-19 in certain hospitalized adults.

This approval was granted following the efficacy and safety data from the Trial AA-1 and Trial AA-2 randomized, double-blind, placebo-controlled studies. Both studies showed that patients who received 2 to 4 mg of baricitinib achieved adequate scalp hair coverage compared with placebo at week 36.

Baricitinib does come with a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. Additionally, it is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

Reference
FDA approves first systemic treatment for alopecia areata. News release. US Food and Drug Administration. June 13, 2022. Accessed June 15, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-systemic-treatment-alopecia-areata