BRAVE-AA-PEDS: Baricitinib Leads to Hair Regrowth in Adolescents with Alopecia Areata

Once-daily oral baricitinib (Olumiant) leads to significant hair regrowth on the scalp, eyelashes, and eyebrows in adolescents with severe alopecia areata after 1 year of treatment, according to new data.1

These 52-week data were presented at the 2025 Fall Clinical Dermatology conference and announced by Eli Lilly and Incyte. The findings on baricitinib 4 mg and its impact on hair regrowth resulted from the phase 3 BRAVE-AA-PEDS study (NCT05723198).

"These promising results for adolescents reinforce what we see in clinical practice with adults, which is that starting treatment with baricitinib early can lead to higher rates of scalp hair regrowth, including near-complete regrowth for many patients," Brittany Craiglow, MD, adjunct associate professor of Dermatology at Yale School of Medicine, said in a statement.1 "Systemic treatments for adolescents shouldn't be the last resort, but part of the treatment conversation among doctors, caregivers and patients from the beginning."

Baricitinib, a once-daily oral Janus kinase (JAK) inhibitor, is described in Lilly’s announcement of these findings as the most extensively researched JAK inhibitor in alopecia areata, with more than 1300 adults and 423 adolescents enrolled across clinical analyses. In 2022, the US Food and Drug Administration (FDA) approved baricitinib for adults with severe alopecia areata, making it the first systemic drug approved in the US for this hair loss condition.

BRAVE-AA-PEDS was the largest phase 3 clinical study of its kind in this population. The findings expand on prior 36-week BRAVE-AA-PEDS results first presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in March.

The ongoing BRAVE-AA-PEDS analysis was designed as a randomized, placebo-controlled phase 3 trial assessing children ages 6 to under 18 years with severe alopecia areata, defined by a Severity of Alopecia Tool (SALT) score of 50 or greater. Such a score indicates at least 50% scalp hair loss. These patients were also required to have had a current alopecia episode lasting between 6 months and 8 years.

At the point of baseline, participants in BRAVE-AA-PEDS had an average of 89% scalp hair loss, with 63.8% classified as having very severe disease and a SALT score score between 95–100. Additionally, 65% of subjects had minimal or no eyebrow hair, as indicated by a Clinician-Reported Outcome (ClinRO) score 2 or 3. Also, 57% had minimal or no eyelash hair (ClinRO score 2 or 3).

The first 2 cohorts of adolescent patients, all of whom were aged 12 to <18 years and weighing at least 30 kg, were included in this newly-released analysis. The first cohort included 257 adolescents, randomized in a 1:1:1 ratio to receive once-daily placebo, baricitinib 4 mg, or baricitinib 2 mg, with the primary endpoint being achievement of a SALT score ≤20. This score would suggest 80% or more scalp hair coverage at Week 36.

The second cohort of 166 adolescents was randomized 1:1 to receive either baricitinib 4 mg or 2 mg to further assess safety. A third cohort, consisting of children ages 6 to under 12 years, will be randomized 1:1:1 to be given a placebo, a high dose of baricitinib, or a low dose of baricitinib. After a single year of baricitinib therapy, 54.1% of individuals on baricitinib 4 mg and 31% on baricitinib 2 mg attained successful scalp hair regrowth.

Additionally, 41.2% of subjects treated with baricitinib 4 mg and 26.2% of those treated with baricitinib 2 mg attained near-complete scalp regrowth, defined as at least 90% coverage (SALT ≤10). In their assessment of eyebrow regrowth, measured as ClinRO scores of 0 or 1 with at least a 2-point improvement from baseline, investigators found such a result occurred in 64.8% of those treated in the baricitinib 4 mg group and 27.8% in the baricitinib 2 mg group.

Similarly, the investigative team noted achievement of eyelash regrowth by 63.3% of those in the baricitinib 4 mg arm and 34% of those in the 2 mg arm. The team also found, among subjects with severe disease at baseline, 71% of those in the baricitinib 4 mg cohort and 58.6% of those in the 2 mg cohort saw successful scalp hair regrowth. Additionally, findings from a separate post-hoc analysis of adolescents diagnosed with severe disease less than 2 years before starting baricitinib, 80% of those on baricitinib 4 mg and 64.3% of those on 2 mg attained successful hair regrowth after 1 year.

The safety profile of this JAK inhibitor in adolescents living with alopecia areata was shown to be consistent with that observed in prior adult and adolescent research, with a lack of new safety signals after a single year of treatment. The most commonly reported treatment-emergent adverse events were shown to be upper respiratory tract infection, acne, and influenza.

The investigators did not identify any opportunistic infections, major adverse cardiovascular events, deaths, or venous thromboembolic events during the trial. These data further support previous results from BRAVE-AA1 and BRAVE-AA2.2 Based on these outcomes, Lilly is set to submit the adolescent data to global health authorities, seeking a potential label update for baricitinib.

References

1. Lilly's baricitinib delivered near-complete scalp hair regrowth at one year for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS trial. Eli Lilly. October 24, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-baricitinib-delivered-near-complete-scalp-hair-regrowth.

2. Smith T. Baricitinib Effective in Holistic Responses Among Patients with Alopecia Areata. HCPLive. April 10, 2025. Accessed October 24, 2025. https://www.hcplive.com/view/baricitinib-effective-holistic-responses-among-patients-alopecia-areata.