Phase III Trial Finds Baricitinib Boosts Hair Regrowth in Adolescents With Severe Alopecia Areata

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Data from the Phase III BRAVE-AA-PEDS (NCT05723198) trial show that adolescents with severe alopecia areata (AA) administered once-daily baricitinib (Olumiant) experienced significant hair regrowth on their scalp, eyebrows, and eyelashes after 36 weeks. Notably, the results indicate this younger patient population experienced faster response rates to baricitinib compared to adult patients with severe AA.^1,2

"Early onset alopecia areata can be more severe, leading to extensive hair loss that frequently does not improve with topicals or corticosteroids often prescribed as first-line therapy," Brittany Craiglow, MD, adjunct associate professor of Dermatology, Yale School of Medicine, said 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."¹

Baricitinib, a disease-modifying antirheumatic drug (DMARD), is an oral, selective, and reversible Janus kinase (JAK) inhibitor. It has gained FDA approval for the treatment of adults with moderately to severely active rheumatoid arthritis who did not achieve an adequate response to other DMARDs, such as tumor necrosis factor antagonists. The FDA also granted emergency use authorization (EUA) to baricitinib plus remdesivir for the treatment of COVID-19 in hospitalized patients who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. The FDA revised the EUA to authorize baricitinib as a standalone treatment in adults, but the EUA remains for patients aged 2 to 17 years.³

Trial Design

The ongoing, placebo-controlled, BRAVE-AA-PEDS trial is evaluating baricitinib in patients aged 6 to less than 18 years with severe AA classified by a Severity of Alopecia Tool (SALT) score of ≥50 and who are currently experiencing an episode of severe AA lasting at least six months but less than eight years.

A total of 257 patients were randomly assigned in a 1:1:1 ratio to receive once-daily placebo, baricitinib at a dose of 4 mg, or baricitinib at a dose of 2 mg. Investigators first enrolled a cohort of patients aged 12 to less than 18 years weighing ≥ 30 kg, with a cohort aged 6 to less than 12 years to begin enrollment over the next year, and another cohort randomly assigned in a 1:1 ratio receive baricitinib 4 mg or baricitinib 2 mg.

The trial’s primary endpoint was a SALT score of ≤20 indicating 80% or greater scalp hair coverage after 36 weeks. At baseline, participants had an average of 89% scalp hair loss, with 65% having minimal or no eyebrow hair and 57% with minimal or no eyelash hair.

The results show that at week 36, 60.0% of patients administered baricitinib 4 mg and 36.9% of patients administered baricitinib 2 mg experienced at least a 50% improvement in SALT score compared to 5.7% of patients administered placebo (p=0.001). For scalp coverage, 42.4% administered baricitinib 4 mg and 27.4% administered baricitinib 2 mg experienced 80% or greater scalp hair coverage compared to 4.5% in the placebo cohort (p=0.001). Further, 36.5% of patients administered baricitinib 4 mg and 21.4% of patients administered baricitinib 2 mg experienced 90% or greater scalp hair coverage compared to 2.3% in the placebo cohort (p=0.001).

For eyebrow and eyelash hair growth, 50.0% administered baricitinib 4 mg and 24.1% administered baricitinib 2 mg experienced significant eyebrow regrowth compared to 0% in the placebo cohort (p<0.01); whereas 42.9% administered baricitinib 4 mg experienced significant eyelash regrowth and 25.5% administered baricitinib 2 mg experienced improved eyelash regrowth compared to 14.0% in the placebo cohort (p=0.002 for 4 mg, p=0.097 for 2 mg).

These 36-week results outpaced outcomes in adults in the BRAVE-AA1 and BRAVE-AA2 trials, which investigators said indicates that hair regrowth with baricitinib may be faster in adolescents compared to adult patients. In the BRAVE-AA1 and BRAVE-AA2 trials, 40.9% of patients administered baricitinib 4 mg and 21.2% of patients administered baricitinib 2 mg achieved 80% or more scalp hair coverage after 52 weeks of treatment.

"With these data, baricitinib is the most well-studied JAK inhibitor in severe alopecia areata, a chronic immune system disorder that can have an especially devastating social and emotional impact on adolescent patients and their families," Anabela Cardoso, senior vice president, Lilly Immunology Medical Affairs, said in the release. "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. We look forward to sharing longer-term data results at upcoming congresses and discussing findings with global regulators in the months ahead."¹

References

1. Lilly's baricitinib delivered high rates of hair regrowth for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS study. News release. Eli Lilly. March 8, 2025. Accessed March 14, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-baricitinib-delivered-high-rates-hair-regrowth

2. A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata (BRAVE-AA-PEDS). ClinicalTrials.gov. Updated February 2, 2025. Accessed March 14, 2025. https://clinicaltrials.gov/study/NCT05723198?term=NCT05723198&rank=1

3. Ahmad A, Zaheer M, Balis FJ. Baricitinib. Updated January 10, 2024. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK572064/