Efficacy and Safety of Baricitinib in Adults with Alopecia Areata: Phase 3 Results from a Randomized Controlled Trial (BRAVE-AA1)

The Phase 3 trial of baricitinib, an oral Janus kinase (JAK)1/JAK2 inhibitor, involved 654 adults with alopecia areata (AA). The patients were divided into three groups: one received 4 mg of baricitinib daily, another received 2 mg, and the last group was given a placebo. After 36 weeks, 35.2% of the 4 mg group and 21.7% of the 2 mg group achieved a Severity of Alopecia Tool (SALT) score of ≤20, compared to only 5.3% in the placebo group. The 4 mg group showed statistical significance over the placebo group by Week 8, and the 2 mg group by Week 24. At Week 36, 26.0% of the 4 mg group and 12.5% of the 2 mg group had a SALT score of ≤10, compared to 3.7% in the placebo group. Adverse events were reported in 59.6% of the 4 mg group, 50.8% of the 2 mg group, and 51.3% of the placebo group, with serious adverse events in 2.1%, 2.2%, and 1.6% respectively. The study concluded that baricitinib 4 mg and 2 mg were superior to placebo in achieving hair regrowth after 36 weeks.