Baricitinib Achieves Up to 80% Scalp Hair Regrowth in Phase 3 Trial for Adolescents with Severe Alopecia Areata

Today, Eli Lilly and Company announced the latest results of the Phase 3 clinical trial, BRAVE-AA-PEDS, for Olumiant (baricitinib), a JAK inhibitor jointly developed with Incyte, for the treatment of adolescent patients (12 to <18 years) with severe alopecia areata (AA). The analysis shows,The patient achieved significant regeneration of the scalp, eyebrows, and eyelashes one year after receiving the treatment. Eli Lilly plans to submit this data to global regulatory authorities to promote the update of the therapy's indication label.And plans to initiate enrollment of pediatric patients aged 6 to <12 years in the BRAVE-AA-PEDS trial next year.

Alopecia areata is an autoimmune disease that causes localized hair loss on the scalp, face, and other parts of the body, and may worsen over time. About 40% of patients with alopecia areata experience their first episode before the age of 20.

At the start of the study, patients had an average scalp hair loss of 89%, with 63.8% assessed as having very severe alopecia areata (Severity of Alopecia Tool [SALT] score 95-100) at baseline. Additionally, 65% of patients had sparse or absent eyebrows (Clinician Reported Outcome [ClinRO] score of 2 or 3), and 57% had sparse or absent eyelashes (ClinRO score of 2 or 3).

The analysis shows that at one year of treatment:

• Among patients treated with 4 mg of baricitinib, 54.1% achieved significant hair regrowth (defined as scalp hair coverage ≥80%, SALT ≤20)., whereas this figure was 31% in patients receiving 2 mg of baricitinib.

• Among patients treated with 4 mg baricitinib, 41.2% achieved nearly complete scalp hair regrowth (defined as scalp hair coverage ≥90%, SALT ≤10), compared to 26.2% in the 2 mg treatment group.

• Among patients treated with 4 mg baricitinib, 64.8% achieved significant eyebrow regrowth (ClinRO score of 0 or 1, with an improvement of ≥2 points from baseline), compared to 27.8% in the 2 mg group.

• Among patients treated with 4 mg of baricitinib, 63.3% achieved eyelash regrowth, compared to 34% in the 2 mg group.

• In patients with severe disease (baseline SALT score 50-94), 71% in the 4 mg group achieved significant hair regrowth., 58.6% for the 2 mg group.

In another post-hoc analysis of adolescent patients diagnosed with severe AA less than two years before treatment initiation,80% of patients receiving 4 mg baricitinib and 64.3% in the 2 mg group achieved significant hair regrowth at one year.

The safety profile of baricitinib in adolescent patients with alopecia areata is consistent with the results from previous clinical trials in adults and adolescents. No new safety signals were identified after one year of treatment. The most common treatment-emergent adverse events included acne, upper respiratory tract infections, and influenza. There were no reports of death, opportunistic infections, major adverse cardiovascular events, or venous thromboembolic events in the study.

Baricitinib is an oral JAK inhibitor taken once daily., which has been approved in more than 75 countries and regions for the treatment of rheumatoid arthritis, and in over 50 countries and regions for the treatment of moderate to severe atopic dermatitis. In 2022, this therapy received FDA approval for the treatment of adult patients with severe alopecia areata, becoming the first systemic therapy approved by the FDA for the treatment of alopecia areata.

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. Retrieved October 24, 2025 from https://www.prnewswire.com/news-releases/lillys-baricitinib-delivered-near-complete-scalp-hair-regrowth-at-one-year-for-adolescents-with-severe-alopecia-areata-in-phase-3-brave-aa-peds-trial-302593426.html

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