For Alopecia Areata, Discontinuation of Baricitinib Linked with Loss of Benefit


A subanalysis of the BRAVE-AA1 study looked at the outcomes of interrupting treatment in responsive patients.

Results from a randomized substudy of the BRAVE-AA1 study suggested that patients with severe alopecia areata who withdrawal from treatment with baricitinib also lose the treatment benefit.

Researchers for the withdrawal substudy looked at responsive patients who had been taking baricitinib up to week 52 of the BRAVE-AA1 study, who were then randomized 3:1 to either stay on their treatment with baricitinib 2 mg (n=39/184, 21.2%) or 4 mg (n=115/281, 40.9%). Following rerandomization, 29 patients in the 2 mg treatment group remained on the treatment and 10 transitioned to placebo, while 85 patients in the 4 mg treatment group remained on the treatment and 30 transitioned to placebo.

In those who transitioned to placebo, 80.0% of those patients in both treatment arms saw a loss of treatment benefit at week 152 (defined as a >20-point worsening in SALT Score from week 52), while a SALT Score ≤20 was maintained at week 152 in 89.7% of the baricitinib 2 mg and 89.4% in the baricitinib 4 mg patients who continued the treatment. The majority of treatment benefit loss occurred between 8 and 24 weeks following withdrawal. In these withdrawal groups, about 62.5% in the 2 mg treatment group and 85.2% of those in the 4 mg group recaptured SALT Score ≤20 upon retreatment with baricitinib.

“Most patients who were withdrawn to placebo experienced a loss of clinical response, including of eyebrow and eyelash,” the authors wrote in their poster. “The majority of those who lost treatment benefit did so between 8 and 24 weeks, suggesting that a short treatment interruption period of 0 to 8 weeks among responders might be possible if needed. Patients were able to recapture their scalp hair regrowth during retreatment, but some required several weeks, possible due to the time necessary to control inflammation before hair follicle recycling can occur.”

Small sample sizes in the withdrawal arms were cited as a study limitation. The poster was presented at Maui Derm 2024.

Source: King B, Kwon O, Vañó-Galván S, et al. Outcomes of Treatment Withdrawal in Patients with Severe Alopecia Areata Treated with Baricitinib: Week 152 Data from Phase 3 BRAVE-AA1. Abstract 13622. Presented at: Maui Derm, January 22-26, 2024.


The study was sponsored by Eli Lilly and Co., under license from Incyte Corporation.

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