Olumiant Becomes the First FDA-Approved Systemic Treatment for Alopecia Areata

Monday’s FDA approval of Olumiant for the treatment of Alopecia Areata (AA) marks a historical change in the procedures used to address Alopecia Areata as it is the first systemic therapy for the disorder. In the United States, more than 300,000 people suffer from AA.  

Alopecia Areata, frequently called Alopecia, is characterized as an autoimmune disorder in which the body attacks its own hair follicles. While there are multiple types of Alopecia, AA is one of the two most common and is characterized by patchy hair loss. Prior to the approval of Olumiant, regimens for AA included topical and injectable steroids focusing only on localized areas rather than addressing hair loss in the whole body.  

Olumiant — the brand name for baricitinib — is characterized as a Janus Kinase (JAK) inhibitor. JAK inhibitors function by impairing cytokine proteins used for cell-to-cell communication. The inhibition of these pathways reduces inflammation, leading to decreased hair loss in AA patients. Currently, Olumiant is being used to treat other autoimmune diseases, most notably rheumatoid arthritis. The recent FDA press release implies that the use of Olumiant may become a standard of care for patients with severe AA. 

As stated in the announcement, two studies were conducted on Olumiant using AA patients who consistently experienced at least 50% hair loss for six months. In both studies, patients received one of the following treatments: a placebo, 2 mg of Olumiant, or 4 mg of Olumiant over the span of several months. Using the Severity of Alopecia Tool (SALT), both studies identified 80% scalp coverage within 36 weeks of the study as a successful treatment. 

The first of the two studies saw a 30% increase in adequate scalp coverage from the placebo for the 4 mg Olumiant group. Even as little as 2 mg of Olumiant led to a 17% increase in sufficient scalp coverage. The second trial corroborated these results by showing a similar trend in scalp coverage. 

“Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata,” said Kendall Marcus, MD, director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research, in the FDA press release 

The approval of a systemic treatment for AA could revolutionize care and quality of life for AA patients. A comprehensive approach can be used to treat the disorder more generally and may help mitigate risks associated with AA diagnosis beyond the physical symptoms.  

According to the American Academy of Dermatology Association, AA correlates with a higher risk of mental health disorders. If Olumiant continues to treat AA symptoms successfully, it may also contribute to reducing mental health issues in AA patients.  

Like many treatments, Olumiant is not without its drawbacks. There are several potential side effects, including GI perforations, respiratory infections, and muscle aches to name a few. Physicians will have to weigh the benefits of using Olumiant to treat AA with its adverse (and potentially life-threatening) side effects.