Adolescents with severe alopecia areata (AA) treated with once-daily, oral baricitinib (Olumiant, Lilly) 2mg and 4mg in the Phase 3 BRAVE-AA-PEDS study saw high rates of hair regrowth at Week 36, according to new research presented at the 2025 meeting of the American Academy of Dermatology in Orlando, FL.

These data show 42.4% of patients receiving baricitinib 4mg and 27.4% of patients receiving baricitinib 2mg achieved 80% or more scalp hair coverage (Severity of Alopecia Tool (SALT) score of ≤20), compared to 4.5% on placebo at 36 weeks.

Additional findings include:

• 60.0% of patients receiving baricitinib 4mg and 36.9% of patients receiving baricitinib 2mg saw at least a 50% improvement in their disease (as measured by SALT score) compared to 5.7% on placebo.
• 36.5% of patients receiving baricitinib 4mg and 21.4% of patients receiving baricitinib 2mg had 90% or more scalp hair coverage (SALT ≤10), compared to 2.3% on placebo.
• Significant regrowth of eyebrows and eyelashes at Week 36 were observed with baricitinib 4mg compared to placebo.
• The safety profile of baricitinib in adolescents with AA was consistent with its known safety profile in adolescent patients with juvenile idiopathic arthritis and moderate-to-severe atopic dermatitis.

Baricitinib was approved by the U.S. Food and Drug Administration in 2022 for adult patients with severe AA.

Pediatric dermatologist Brittany Craiglow, MD, an Associate Adjunct Professor in the Department of Dermatology at Yale School of Medicine in New Haven, CT, spoke to The Dermatology Digest about the new findings and their implications.

TDD:  Please describe the unmet need for treating adolescents with AA.

Dr. Craiglow: “AA can be an absolutely devastating disease for all patients, but adolescents often face unique challenges.  Many of our patients experience anxiety, depression, bullying, social withdrawal, and bullying, and this disease can truly alter the trajectory of one’s life.  Currently, only ritlecitinib (Litfulo, Pfizer) is FDA-approved for severe AA in this population.“

TDD: How may baricitinib help fill this void?

Dr. Craiglow: “The cohort studied represents the largest clinical trial in adolescents with severe AA to date.  If approved, baricitinib would provide another much-needed treatment option for adolescent patients with AA.  Having been authorized for years in 70 countries for other pediatric indications, including atopic dermatitis and juvenile idiopathic arthritis in patients as young as age 2, baricitinib brings with it an unparalleled legacy of safety in this population.“