First FDA Approved Systemic Treatment For Alopecia Areata

Alopecia areata is a common disorder that can have a large adverse impact on the quality of life of individuals. It’s considered an autoimmune disorder that causes your hair to come out, often in clumps the size and shape of a quarter. The disorder affects more than 300,000 people in the US each year.

The amount of hair loss is different for everyone. Some people lose it only in a few spots, while others lose a lot. 

A medication called Baricitinib, which is an oral inhibitor of Janus kinase (JAK) types 1 and 2, produced substantial rates of hair growth with acceptable tolerability for patients with alopecia areata in 2 phase 3 trials.

Recently, the FDA approved barcitinib for the treatment of severe alopecia areata after a review of the results of those 2 trials.

Up to 35% of Participants had an 80% scalp Hair Coverage

Patients in the trials got either a placebo, 2 mg of barcitinib, or 4 mg of barcitinib every day. The primary goal was the proportion of patients who achieved at least 80% scalp hair coverage at week 36.

In the first trial (BRAVE AA-1), 22% of the 184 patients who received 2 mg of the medication and 35% of the 281 who received 4 mg achieved at least 80% scalp hair coverage, compared with 5% in the placebo group. 

In the second trial (BRAVE AA-2), 17% of the 156 patients who received 2 mg and 32% of the 234 who received 4 mg achieved at least 80% scalp hair coverage. 

Before the approval, the FDA-approved treatments for moderate to severe alopecia areata included intralesional steroid injections, contact sensitization, and systemic immunosuppressants, but they had limited efficacy. 


FDA OKs First Systemic Treatment for Alopecia Areata – Medscape – Jun 13, 2022. Retrieved from: 

JAK Inhibitor Provides Impressive Hair Growth for Patients With Alopecia Areata – Medscape – Oct 04, 2021. Retrieved from:

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