STUDY DESIGN

Baricitinib, a selective Janus kinase (JAK) inhibitor approved for severe alopecia areata (AA) in adults, has been evaluated in adolescents aged 12-18 years.¹ Across both adult and adolescent studies, baricitinib demonstrated clinically meaningful hair regrowth, with ≥80% scalp coverage in a substantial proportion of patients.¹ However, the commonly used primary endpoint of Severity of Alopecia Tool (SALT) score of ≤20 may not fully reflect complete regrowth.¹ As achieving full scalp hair regrowth remains a key treatment goal, the BRAVE-AA trials further assessed the complete response thresholds of SALT ≤10 and ≤5 among SALT ≤20 responders through week 52 in both adults and adolescents.¹

The BRAVE-AA program included two adult studies (BRAVE-AA1 and BRAVE-AA2) and one adolescent study (BRAVE-AA-PEDS).¹ Common inclusion criteria required a SALT score ≥50 at screening and baseline, an AA episode lasting >6 months to <8 years, and no spontaneous improvement within 6 months.¹ For BRAVE-AA-PEDS, eligible patients were aged 12 to <18 years, weighed ≥30kg, had a confirmed AA diagnosis for ≥1 year, and had failed more than one previous therapy.¹ History of psychological counseling and evidence of psychological distress related to AA were also criteria for inclusion.¹ For BRAVE-AA1 and BRAVE-AA2, adults aged ≥18 years (males <60, females <70) were eligible.¹ Compared to the adult population, a greater proportion of adolescents had very severe baseline disease, atopic dermatitis, and asthma.¹

Following a 5-week screening and washout period, 257 adolescents were randomized 1:1:1 to placebo, baricitinib 2mg, or 4mg daily, with placebo patients switched to active treatment at week 36.¹ A total of 1,200 adults were randomized 2:2:3 to placebo, baricitinib 2mg, or 4mg daily, with placebo patients also switching to active treatment at week 36.¹ All participants were followed for 52 weeks, and treatment response was assessed using SALT scores at prespecified timepoints.¹ The primary endpoint was the proportion of responders with SALT ≤20 at week 36.¹ The key outcomes assessed in this analysis were the proportion of responders with deeper responses (SALT ≤10 [near-complete scalp coverage] or ≤5 [complete scalp coverage]) with baricitinib 2mg or 4mg in week 4-52.¹

FINDINGS