New Data on Hair Regrowth in Severe Alopecia Areata Using Baricitinib, with Brittany Craiglow, MD

At the American Academy of Dermatology (AAD) Annual Meeting in Orlando, the HCPLive team sat down with assistant professor adjunct dermatology Brittany Craiglow, MD, of the Yale School of Medicine, who highlighted recent positive phase 3 results of baricitnib for adolescents aged 12 - 17 with severe alopecia areata.1,2

In this interview, Craiglow was asked about the study’s primary endpoints and the team’s most notable findings presented at the AAD 2025 meeting. These findings were the 36-week efficacy and safety results drawn from the adolescent cohort of BRAVE-AA-PEDS, a placebo-controlled analysis that is ongoing and assesses children ≥6 years and adolescents 12 to <18 years of age who are suffering from severe alopecia areata.

“So this was a clinical trial of baricitinib for severe alopecia areata in adolescents, so patients ages 12 - 17, and the design was very similar to the adult clinical trials that led to the approval of baricitinib for severe AA back a few years ago now,” Craiglow said. “So patients had to have a SALT score of at least 50, which is 50% scalp hair loss. But it was a very severe group of patients. Their average salt score was around 90, so many of these patients had absolutely no scalp hair. Patients were randomized to either baricitinib, 4 milligrams, 2 milligrams, or placebo, and then they were followed for 36 weeks, and that's where the primary endpoint was.”

In terms of the team’s primary endpoints, Craiglow noted that they evaluated the percent of patients who attained a Severity of Alopecia Tool (SALT) score of 20 or less, which represents 80% or more coverage with scalp hair. By the 36-week mark, Craiglow commented that a significantly higher proportion of those in the baricitinib treatment arm versus placebo were able to achieve a 50% and 90% SALT improvement.

“Patients on the 4 milligram dose, or over 40% of those patients actually met that end point, which is really exciting,” Craiglow explained. “You know, this is a population where AA is kind of hard for everybody. But I think we can all look back on our adolescents and think about what that was like, even without alopecia, and we can imagine what it might be like to be a kid navigating life without hair, eyebrows, eyelashes, etc.”

For additional information on this topic, view the full video interview posted above. To find out more from AAD 2025, view our latest conference coverage.

The quotes used in this summary were edited for the purposes of clarity. Craiglow has reported personal fees from AbbVie, Concert Pharmaceuticals, Incyte, Eli Lilly and Company, Pfizer, Regeneron, and Sanofi-Genzyme.

References

1. Passeron T, Soung T, Ohyama M, et al. Baricitinib Provides Significant Hair Regrowth in Adolescents With Severe Alopecia Areata: 36-Week Efficacy and Safety Results From a Phase 3 Randomized, Controlled Trial. Presented at the 2025 American Academy of Dermatology (ADA) Annual Meeting. Orlando, FL. March 07-11, 2025.

2. Lilly's baricitinib delivered high rates of hair regrowth for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS study. Eli Lilly and Company. Maerch 8, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-baricitinib-delivered-high-rates-hair-regrowth.