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Conference News From the Journals American Academy of Dermatology Annual Meeting

Baricitinib Effective for Teen Alopecia

Eli Lilly's JAK inhibitor demonstrated 80% scalp hair regrowth in 42.4% of adolescents with severe alopecia areata after just 36 weeks of treatment, outperforming placebo in the Phase 3 BRAVE-AA-PEDS trial.

Conexiant

A phase III clinical trial has demonstrated that baricitinib (Olumiant) may provide significant hair regrowth in adolescent patients with severe alopecia areata, according to late-breaking results presented at the American Academy of Dermatology Annual Meeting in Orlando.

The BRAVE-AA-PEDS study showed that after 36 weeks of treatment, 42.4% of adolescent patients receiving 4 mg of baricitinib daily achieved 80% or more scalp hair coverage compared with just 4.5% of those receiving placebo (P = .001), according to a press release from Eli Lilly and Company.

The randomized, placebo-controlled trial enrolled 257 patients aged 12 to 17 years with severe alopecia areata (AA). Reseaerchers randomly assigned the patients to receive once-daily baricitinib 4 mg, baricitinib 2 mg, or placebo. At baseline, the participants had an average of 89% scalp hair loss, with 65% having minimal or no eyebrow hair and 57% having minimal or no eyelash hair.

"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 Brittany Craiglow, MD, Adjunct Associate Professor of Dermatology at the Yale School of Medicine. "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 highlighted.

The study's primary endpoint was achievement of a Severity of Alopecia Tool (SALT) score ≤ 20, indicating 80% or more scalp hair coverage at Week 36. The results showed dose-dependent efficacy:

  • 60.0% of patients receiving baricitinib 4 mg and 36.9% receiving baricitinib 2 mg saw at least a 50% improvement in their disease (as measured by SALT score) compared with 5.7% receiving placebo (P = .001).
  • 42.4% of patients receiving baricitinib 4 mg and 27.4% receiving baricitinib 2 mg achieved 80% or more scalp hair coverage compared with 4.5% receiving placebo (P = .001).
  • 36.5% of patients receiving baricitinib 4 mg and 21.4% receiving baricitinib 2 mg had 90% or more scalp hair coverage (SALT ≤10) compared with 2.3% receiving placebo (P = .001).

The drug also demonstrated efficacy in regrowing eyebrows and eyelashes:

  • 50.0% of patients receiving baricitinib 4 mg and 24.1% receiving baricitinib 2 mg achieved significant eyebrow regrowth compared with 0% receiving placebo (P < .01).
  • 42.9% of patients receiving baricitinib 4 mg achieved significant eyelash regrowth compared with 14.0% receiving placebo (P = .002).

Notably, the results achieved by adolescents at 36 weeks were comparable to those achieved by adults after 52 weeks of treatment in the previous BRAVE-AA1 and BRAVE-AA2 studies, suggesting potentially faster hair regrowth in the adolescent population.

The most common treatment-emergent adverse events included acne, influenza, and upper respiratory tract infections. A higher frequency of serious adverse events was observed in the placebo group compared with the baricitinib groups. No deaths, opportunistic infections, major adverse cardiovascular events, venous thromboembolic events, or malignancies were reported during the trial.

The safety profile observed in adolescent patients with AA was consistent with that seen in clinical trials of baricitinib for adolescent patients with juvenile idiopathic arthritis and moderate-to-severe atopic dermatitis.

"With these data, baricitinib is the most well-studied [Janus kinase] (JAK) inhibitor in severe [AA], a chronic immune system disorder that can have an especially devastating social and emotional impact on adolescent patients and their families," said Anabela Cardoso, Senior Vice President of Lilly Immunology Medical Affairs. "We are excited about these initial results, which show baricitinib can provide significant scalp hair regrowth in adolescents, potentially at an even faster rate compared to adults," she underscored.

Baricitinib, an oral JAK inhibitor developed by Incyte and licensed to Eli Lilly, was previously approved by the U.S. Food and Drug Administration in 2022 for adult patients with severe AA. Additional data from the BRAVE-AA-PEDS study will be presented at scientific meetings later in 2025, with results to be submitted for peer-reviewed publication.