Treatment Superior to Placebo for Hair Regrowth Among Patients With Alopecia Areata

In a pair of phase 3 trials, oral baricitinib outperformed placebo for hair regrowth in patients with severe alopecia areata, according to findings published in The New England Journal of Medicine.

“Alopecia areata is an autoimmune condition characterized by rapid hair loss in the scalp, eyebrows, and eyelashes, for which treatments are limited,” wrote researchers. “Baricitinib, an oral, selective, reversible inhibitor of Janus kinases 1 and 2, may interrupt cytokine signaling implicated in the pathogenesis of alopecia areata.”

The BRAVE-AA1 and BRAVE-AA2 trials randomized adults with severe alopecia areata 3:2:2 to once-daily baricitinib at a dose of 4 mg, baricitinib at a dose of 2 mg, or placebo.

All 654 patients in BRAVE-AA1 and 546 patients in BRAVE-AA2 had a score of 50 or higher on the Severity of Alopecia Tool (SALT) at baseline. SALT scoring ranges from 0 to 100, with 0 indicating no scalp hair loss and 100 complete scalp hair loss.

At week 36, the primary outcome of a SALT score of 20 or less was achieved by 38.8% with 4-mg baricitinib, 22.8% with 2-mg baricitinib, and 6.2% with placebo in BRAVE-AA1. In BRAVE-AA2, the outcome was achieved by 35.9% with 4-mg baricitinib, 19.4% with 2-mg baricitinib, and 3.3% with placebo, according to study authors.

The difference between 4-mg baricitinib and placebo was 32.6 percentage points in both BRAVE-AA1 and BRAVE-AA2. The difference between 2-mg baricitinib and placebo was 16.6 percentage points in BRAVE-AA1 and 16.1 percentage points in BRAVE-AA2.

Secondary outcomes mostly favored 4-mg baricitinib over placebo, but not 2-mg baricitinib over placebo, the study showed. Acne, elevated levels of creatine kinase, and increased levels of both low- and high-density lipoprotein cholesterol occurred more frequently with baricitinib.

“Longer trials are required to assess the efficacy and safety of baricitinib for alopecia areata,” concluded researchers.

The study was funded by Eli Lilly under license from Incyte.

Reference:
King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. The New Engl J Med. 2022;386(18):1687-1699. doi:10.1056/NEJMoa2110343