Baricitinib Restores Hair Growth in Adolescents With AA

ORLANDO, Fla. — Adolescents with severe or very severe alopecia areata (AA) were able to regrow hair, some with a 90% improvement in hair loss, after taking the Janus kinase inhibitor baricitinib daily, results of a phase 3 clinical trial showed.

“Three out of 10 patients with very severe alopecia areata at baseline achieved a SALT [Severity of Alopecia Tool] score below 20, and 7 of 10 patients with severe alopecia areata achieved a SALT score below 20 at 36 weeks,” Thierry Passeron, MD, PhD, chair of Dermatology at the University Coté d’Azur in Nice, France, said in presenting results of the phase 3 BRAVE-AA-PEDS trial during the late breakers session at the American Academy of Dermatology (AAD) 2025 Annual Meeting. A SALT20 score equates to 80% or more of scalp coverage, Passeron said.

The trial enrolled 257 adolescents aged 12-18 years with AA and a SALT score ≥ 50 at screening. Patients were randomized to one of three groups: Oral baricitinib 4 mg or 2 mg once daily, or a placebo. Other key eligibility criteria were an AA diagnosis for a year or more and a current episode of AA lasting 6 months to 8 years (the average duration was 6.6 years), failure with at least one other treatment for AA, and a history of psychological counseling for AA. Passeron reported the 36-week results.

Baricitinib (Olumiant) is currently approved by the US Food and Drug Administration for treatment of severe AA in adults.

Study Results

Almost half of the patients (47%) on baricitinib 4 mg achieved a SALT score of 20 or lower, as did more than a quarter (27.4%) of patients on 2 mg vs 4.5% of the placebo group, Passeron said. Over one third (36.5%) of those on 4 mg had a more robust response, measured as a SALT score of 10 or lower, compared with 21.4% of those in the 2-mg group and 2.3% in the placebo group.

“Significantly higher proportions of adolescents treated with baricitinib vs placebo achieved a 50% and 90% improvement in SALT,” Passeron said.

In the baricitinib 4-mg group, 60% of patients had a 50% improvement or greater in the SALT score vs 36.9% of the 2-mg group and 5.7% on placebo (P = .001). One third of those on 4 mg had a 90% or better improvement in SALT, as did 20.2% of the 2-mg group and 1.1% of the placebo group.

The study also evaluated outcomes for patients with severe and very severe AA, defined as a SALT score of 50-94 and 95-100, respectively. Among those with severe AA, 67.7% of patients on 4 mg baricitinib and 51.7% of those on 2 mg met the primary endpoint of a SALT score of 20 or lower vs 6.3% of those on placebo. Among those with very severe AA, 27.8% of patients on 4 mg therapy and 14.5% of those on 2 mg therapy reached that endpoint vs 1.8% of those on placebo.

“Safety outcomes were also consistent with other trials of baricitinib,” Passeron said. Acne was the most frequent treatment-related side effect, affecting 8.9% of both treatment groups and 4.5% of patients on placebo.

In an interview with Medscape Medical News, Passeron said the trial is “by far the largest study” of oral baricitinib for AA, and the primary endpoint of a SALT score of 20 or lower was significant. “We know that depending on where the lesions are located, when you reach SALT20, your quality of life is usually improved,” he said.

Baricitinib is also being evaluated for AA in patients aged 6-12 years, Passeron said. “These children are suffering a lot more,” he said. Results of that study may be available next year, he added.

An Increasing Number of Options

Baricitinib would be an important addition to the dermatologist’s toolbox for treating AA in younger patients, Robert Dellavalle, MD, PhD, chair of Dermatology at the University of Minnesota in Minneapolis and national dermatology executive program director of the Department of Veterans Affairs, told Medscape Medical News.

“There are an increasing number of options, but it used to be that nothing worked, so these were very sad clinics,” Passeron said. “Young people are responding, and those people are now very happy. It’s a very different environment for these types of clinics now than, say, 10, 20 years ago.”

Cost of the biologic may be an issue for some patients and their families, as is safety, Dellavalle said, but having another option for younger patients with AA — ritlecitinib has already been approved for patients aged 12 years or older with severe AA — is noteworthy, he added.

“It’s better to treat AA early when it’s presenting than later on after it’s been established for a while without treatment to try to modify the disease,” he said.

“The major thing is, this trial is showing safety and efficacy in a good percentage of adolescents, leading to earlier treatment for those kids,” Dellavalle added.

The study was funded by Eli Lilly and Company. Passeron disclosed a financial relationship with Eli Lilly and Company, as well as AbbVie, Almirall, Amgen, Astellas Pharma US, Beiersdorf, Bioderma, Celgene Corporation, Cutera, Inc., Galderma, GlaxoSmithKline, Hyphens Pharma, Incyte Corporation, ISDIN, Janssen-Cilag, L’Oreal, La Roche-Posay, LEO Pharma, Mesoestetic USA Laboratories, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi, Sun Pharmaceutical Industries, Symrise, Takeda Pharmaceuticals USA, Vichy Laboratories, and VYNE Therapeutics. Dellavalle reported no relevant financial relationships.

Richard Mark Kirkner is a medical journalist based in Philadelphia.