Baricitinib tied to hair regrowth in adolescents with severe AA

Once-daily treatment with baricitinib resulted in clinically meaningful improvements in hair regrowth on the scalp, eyebrows, and eyelashes among adolescent patients with severe alopecia areata (AA), according to the BRAVE-AA-PEDS trial presented at AAD 2025.

“Early onset AA can be more severe, leading to extensive hair loss that frequently does not improve with topicals or corticosteroids often prescribed as first-line therapy,” said Prof Brittany Craiglow from Yale School of Medicine, in a press release.

“These initial results are exciting because they demonstrate that baricitinib can provide significant hair regrowth for adolescents at 36 weeks, a promising early signal of baricitinib's potential as an effective treatment for adolescents with severe disease,” she added.

The ongoing, phase III BRAVE-AA-PEDS study included 257 adolescents (aged 12–18 years) with severe AA, as indicated by a Severity of Alopecia Tool (SALT) score of ≥50. At baseline, 89 percent had scalp hair loss, 65 percent had minimal or no eyebrow hair (ClinRO* score of 2 or 3), and 57 percent had minimal or no eyelash hair (ClinRO score of 2 or 3).

Participants were randomized in a 1:1:1 ratio to receive once-daily oral baricitinib 4 or 2 mg or placebo. The primary endpoint of this study was achievement of SALT score ≤20, which indicates ≥80 percent scalp hair coverage, at 36 weeks.

By week 36, significantly more patients treated with either dose of baricitinib demonstrated a ≥50-percent improvement in SALT score than those treated with placebo (60.0 percent [4 mg] and 36.9 percent [2 mg] vs 5.7 percent; p=0.001). [AAD 2025, abstract S040]

Additionally, a significantly higher proportion of baricitinib recipients achieved ≥90-percent scalp hair coverage, as indicated by a SALT score of ≤10, compared with placebo recipients (36.5 percent [4 mg] and 21.4 percent [2 mg] vs 2.3 percent; p=0.001).

Significant eyebrow regrowth, as indicated by ClinRO scores of 0 or 1 with a ≥2 point improvement from baseline, occurred in 50 percent and 24.1 percent of those on baricitinib 4 or 2 mg, respectively, whereas none was observed among those on placebo (p<0.01).

Eyelash regrowth was also more prevalent in the baricitinib group (4 mg: 42.9 percent; p=0.002; 2 mg: 25.5 percent; p=0.097) than the placebo group (14 percent).

The results were consistent with those observed in previous phase III studies (BRAVE-AA1 and BRAVE-AA2) involving adults with AA, which revealed that treatment with baricitinib 4 or 2 mg was superior to placebo in terms of hair regrowth at 36 weeks, with a higher percentage of patients achieving a SALT score of ≤20. [N Engl J Med 2022;386:1687-1699]

Moreover, the BRAVE-AA-PEDS results indicated that adolescents may experience faster hair regrowth with baricitinib than adults, the researchers noted.

Safety endpoints

Acne, influenza, and upper respiratory tract infection were the most common treatment-emergent adverse events (TEAEs) reported.

The placebo group experienced more serious AEs than the baricitinib group, but no deaths, opportunistic infections, major adverse cardiovascular events, and venous thromboembolic events or malignancies were documented.

The safety profile of baricitinib in adolescents with AA was similar to that seen in clinical trials for adolescent patients with juvenile idiopathic arthritis and moderate-to-severe atopic dermatitis, according to a press release.