Baricitinib Regrows Hair in Adolescents With AA

Baricitinib significantly improved scalp hair regrowth, with 80% or more scalp hair coverage in 42% of adolescents with severe alopecia areata (AA) at 36 weeks, with a favorable safety profile. Similarly, eyebrow and eyelash regrowth were also significantly improved.

The ongoing phase 3, placebo-controlled BRAVE-AA-PEDS trial (NCT05723198) is investigating the efficacy and safety of baricitinib for adolescents aged 12 to 17 years with severe AA. Prof. Thierry Passeron, MD, PhD, Nice University Hospital, France, reported the initial readout of efficacy and safety of the 36-week outcomes.¹

Participants with scalp hair loss of 50% of more (SALT ≥50) were randomized to receive baricitinib 4 mg, 2 mg, or placebo and followed up for 36 weeks. The primary end point was the percentage achieving a SALT score of 20 or lower, indicating 80% or greater scalp hair coverage. At the start of the study, participants had an average of 89% scalp hair loss (near total hair loss), 65% had minimal or no eyebrow hair (clinician-reported outcome [ClinRO] score of 2 or 3), and 57% had minimal or no eyelash hair (ClinRO score of 2 or 3).

By week 36, a significantly higher proportion of baricitinib-treated participants achieved SALT20 compared with placebo. More than 42% of participants in the 4-mg group reached this end point, a significant improvement over placebo (P<0.01). Participants taking baricitinib also showed substantial SALT50 and SALT90 responses, indicating high levels of hair regrowth. Fifty percent of participants receiving baricitinib 4 mg and 24.1% of those receiving baricitinib 2 mg achieved significant eyebrow regrowth (ClinRO scores of 0 or 1 with a ≥2 point improvement from baseline) compared with 0% in the placebo arm (P<0.01). Significant eyelash regrowth in 42.9% of participants receiving baricitinib 4 mg was reported, and 25.5% receiving baricitinib 2 mg saw improved eyelash regrowth, compared with 14.0% receiving placebo (P=0.002 for 4 mg; P=0.097 for 2 mg).

Baricitinib was well tolerated, with no new safety concerns. Most treatment-emergent adverse events were mild to moderate, and none led to treatment discontinuation. Acne, influenza, and upper respiratory tract infection were the most common side effects, with a higher frequency seen in the placebo group compared with the treatment groups.

Medical writing support was provided by Dr. Rachel Giles.
Copyright ©2025 Medicom Medical Publishers