FDA Approves First Alopecia Areata Treatment

The US Food and Drug Administration (FDA) has approved baricitinib (olumiant) for the treatment of severe alopecia areata in adults. This is the first approval of a systemic treatment for alopecia areata.  

This approval follows the results of 2 randomized, placebo-controlled trials. Included participants had at least 50% scalp hair loss for more than 6 months prior to the trial. Participants randomly received a placebo, 2 mg of baricitinib, or 4 mg of baricitinib orally each day.

The efficacy of baricitinib was measured by the number of participants who achieved 80% or greater scalp hair coverage at the end of the 36-week study period. The Severity of Alopecia Tool was utilized to measure hair loss.

In the first trial, 22% (n = 184) of patients in the 2-mg group and 35% (n = 281) in the 4-mg group had achieved 80% or greater scalp hair coverage. In comparison, 5% (n = 189) of the placebo group had achieved adequate coverage. In the second trial, 17% (n = 156) of the 2-mg group and 32% of the 4-mg group had achieved adequate coverage, compared with 3% (n = 156) of the placebo group.

Baricitinib was originally approved for the treatment of moderate to severe rheumatoid arthritis in 2018, before being approved to treat COVID-19 in certain hospitalized patient populations. Baricitinib should not be used with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

Common adverse effects include upper respiratory tract infections, hyperlipidemia, anemia, and shingles, among others. Serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis are part of a boxed warning for baricitinib.

Patients taking baricitinib should be monitored closely for infection during and following treatment, active tuberculosis infection and latent tuberculosis prior to treatment, and viral reactivation.


—Leigh Precopio



FDA approves first systemic treatment for alopecia areata. News release. US Food and Drug Administration; June 13, 2022. Accessed June 22, 2022.