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AAD: Baricitinib Tops Placebo for Hair Regrowth in Alopecia Areata

In two phase 3 trials, baricitinib superior to placebo in terms of percentage of patients with a SALT score of 20 or less at week 36

By Physician’s Briefing Staff | May 07, 2022

For adults with severe alopecia areata, oral baricitinib is superior to placebo with respect to hair regrowth at 36 weeks, according to a study published online March 26 in the New England Journal of Medicine to coincide with presentation at the annual meeting of the American Academy of Dermatology, held from March 25 to 29 in Boston.

Brett King, M.D., Ph.D., from the Yale School of Medicine in New Haven. Connecticut, and colleagues conducted two randomized, placebo-controlled, phase 3 trials involving adults with severe alopecia areata with a Severity of Alopecia Tool (SALT) score of 50 or higher (654 participants in the BRAVE-AA1 trial and 546 in the BRAVE-AA2 trial). Participants were randomly assigned to receive once-daily baricitinib at a dose of 4 mg, baricitinib at a dose of 2 mg, or placebo in a 3:2:2 ratio.

The researchers found that the estimated percentage of patients with a SALT score of 20 or less at week 36 was 38.8, 22.8, and 6.2 percent with 4- and 2-mg baricitinib, and placebo in BRAVE-AA1 and 35.9, 19.4, and 3.3 percent, respectively, in BRAVE-AA2. In BRAVE-AA1, the difference between 4-mg baricitinib and placebo was 32.6 percent, and the difference between 2-mg baricitinib and placebo was 16.6 percent; the corresponding values were 32.6 and 16.1 percent in BRAVE-AA2. Secondary outcomes generally favored baricitinib over placebo for baricitinib at a dose of 4 mg but not 2 mg.

"Longer trials are necessary to determine the efficacy and safety of baricitinib for alopecia areata, and the current trials are ongoing and are planned to remain randomized and blinded for up to 200 weeks," the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including Eli Lilly, which manufactures baricitinib and supported the study under license from Incyte.

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