Baricitinib shows promise for adolescent alopecia areata in phase 3 trial

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Baricitinib, an oral Janus kinase (JAK) inhibitor, demonstrated significant hair regrowth in adolescents with severe alopecia areata (AA), according to 36-week results from a phase 3 trial presented at the 2025 American Academy of Dermatology (AAD) Conference. The study, known as BRAVE-AA-PEDS, was sponsored by Eli Lilly and Company and involved 257 adolescents aged 12 to under 18 years.

Study overview

Alopecia areata is an autoimmune disorder causing hair loss, often impacting young patients' self-esteem and quality of life. Approximately 40% of patients experience their first onset during childhood or adolescence, making effective treatment options crucial. While baricitinib is already approved for adult AA and for atopic dermatitis in children aged 2 and above, its efficacy and safety in younger patients with AA had not been fully explored.

The BRAVE-AA-PEDS trial was a randomized, placebo-controlled study evaluating two dosages of baricitinib (2 mg and 4 mg) against a placebo. Participants were required to have a Severity of Alopecia Tool (SALT) score of 50 or higher, indicating substantial hair loss, and a history of unsuccessful treatment attempts. The primary goal was to determine the proportion of patients achieving a SALT score of 20 or less, representing significant hair regrowth.

Promising results at 36 weeks

At the 36-week mark, 42% of adolescents receiving the 4 mg dose of baricitinib achieved a SALT score of 20 or less, compared to just 2% in the placebo group. The 2 mg dose also showed effectiveness, with 21% of patients reaching the primary endpoint. Additionally, the higher dose led to 60% of patients achieving at least a 50% improvement in SALT scores, while the lower dose reached 37%. In contrast, only 5% of those on placebo showed similar improvement.

Eyebrow and eyelash regrowth were also notably higher in the baricitinib groups. By week 36, 43% of patients on the 4 mg dose experienced significant eyebrow regrowth, compared to 14% in the placebo group. Eyelash regrowth followed a similar pattern, with 50% of patients on the higher dose showing improvement versus none in the placebo group.

"Both the efficacy and safety results are unbelievably exciting.," said Brittany Craiglow, MD, board certified, pediatric, adolescent dermatology, in an interview with Contemporary Pediatrics®.

She added, "Alopecia areata can be an absolutely devastating disease for patients of any age, but adolescence is already an especially vulnerable time. Many of our patients experience bullying, social withdrawal and even thoughts of self-harm, and this disease can truly alter the trajectory of one’s life. Having a safe and effective treatment option with a legacy of use in pediatric patients as young as age 2 for other indications will be life-changing for so many patients and their families."

Safety profile and adverse events

The safety profile of baricitinib was consistent with previous studies in adults and children with atopic dermatitis. Treatment-emergent adverse events (TEAEs) were reported in 65.5% of patients receiving baricitinib, compared to 53.4% in the placebo group. Most TEAEs were mild to moderate, with acne, headaches, and upper respiratory tract infections being the most common. Severe adverse events were rare, with no reports of deaths, malignancies, or major cardiovascular events. One serious infection, a case of non-complicated appendicitis, was reported and resolved within five days.

Unmet needs and future directions

Despite recent approvals of other JAK inhibitors for adolescents, an unmet need for effective treatment options for severe AA remains. The trial’s findings suggest that baricitinib could become a valuable option for this population, offering significant hair regrowth and an acceptable safety profile. Long-term extension studies are ongoing to evaluate the durability and safety of these results beyond 36 weeks.

"Currently there is only one FDA-approved treatment for adolescents with severe AD – ritlecitinib," said Craiglow. "If approved, baricitinib will provide another option for patients in this age group. We are seeing in clinical practice that patients have different responses to different JAK inhibitors, so this will be a welcome addition to our treatment armamentarium. The highly favorable safety profile of baricitinib and history of use in very young patients for other diseases will provide added confidence to prescribers."

Reference:

Passeron T, Soung J, Kwon O, 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 (AAD) Conference. Orlando, Florida.