Baricitinib regrows hair in adolescents with alopecia areata

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 favourable safety profile. Similarly, eyebrow and eyelash regrowth were significantly improved.

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

Participants with ≥50% scalp hair loss (SALT ≥50) were randomised to receive baricitinib 4 mg, 2 mg, or placebo and followed for 36 weeks. The primary endpoint was the percentage achieving a SALT score ≤20, indicating 80% or more 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 (see Figure). More than 42% of participants in the 4 mg group reached this endpoint, a significant improvement over placebo (P<0.01). Participants taking baricitinib also showed substantial SALT50 and SALT90 responses, indicating high levels of hair regrowth. Significant eyebrow regrowth (ClinRO scores of 0 or 1 with a ≥2 point improvement from baseline) was achieved by 50.0% of participants receiving baricitinib 4 mg and 24.1% of those receiving baricitinib 2 mg compared with 0% in the placebo arm (P<0.01). Significant eyelash regrowth was reported in 42.9% of participants receiving baricitinib 4 mg, and 25.5% receiving baricitinib 2 mg saw improved eyelash regrowth, compared with 14.0% on placebo (P=0.002 for 4 mg; P=0.097 for 2 mg).

Figure: Percentage of BRAVE-AA-PEDS participants achieving SALT20 at week 36 [1]



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.

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   1. Passeron T, 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. Abstract 66759, LBA session 2, 2025 AAD Annual Meeting, 07–11 March, Orlando, FL, USA.

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Posted on 17 April 202517 April 2025