Baricitinib Provides Higher Efficacy in Adolescents Relative to Adults With Alopecia Areata Despite More Severe Disease at Baseline: 36-Week Outcomes From BRAVE-AA Trials

Abstract

Background: Baricitinib (Bari), an oral, selective, Janus kinase inhibitor, is approved for severe alopecia areata (AA) in adults and is being studied in children.

Methods: BRAVE-AA-PEDS is a phase 3 trial of pediatric subjects (6 to <18 years [y]) with severe AA (Severity of Alopecia Tool [SALT] score ≥50); BRAVE-AA1 and -AA2 are trials in adults. In BRAVE-AA-PEDS (adolescents, 12 to <18y) and BRAVE-AA1/AA2, subjects were randomly assigned to once-daily Bari 4mg, Bari 2mg, or placebo. Primary endpoint was % of patients with SALT score ≤20 at Week (W) 36. We compared baseline (BL) characteristics and W36 efficacy and safety in adolescents (N=257) vs adults (N=1200).

Results: BL characteristics of adolescents and adults, respectively: female, 49.4% vs 60.7%; mean age(y), 14.7 vs 37.5; mean onset age(y), 7.9 vs 25.3, mean disease duration(y), 6.4 vs 12.2; mean current AA episode duration(y), 3.2 vs 3.9; BL SALT score 95-100, 63.8% vs 53.2%. In adolescents and adults, respectively, SALT score <20 was achieved by 42.4% vs 34% of patients on Bari 4mg, 27.4% vs 19.7% on Bari 2mg, and 4.5% vs 4.1% on placebo. Of patients with BL SALT score 50-94, 68% of adolescents vs 48% of adults achieved the primary endpoint. Common adverse events: headache, acne, and upper respiratory tract infection.

Conclusion: Bari is effective and safe for severe AA in both adolescents and adults. Adolescents had higher W36 response rates despite higher BL severity, suggesting benefits of early intervention.