Baricitinib/Alemin leads to significant hair regrowth in adolescents with severe alopecia areata

Baricitinib (Baricitinib), an oral Janus kinase (JAK) 1/2 inhibitor, resulted in significant scalp, eyelash and eyebrow regrowth in adolescents with severe alopecia areata at 52 weeks, according to data to be released in fall 2025 and announced by Eli Lilly and Company. In the Phase 3 BRAVE-AA-PEDS study (NCT05723198), 71% of adolescents with severe disease successfully achieved scalp hair regrowth at 52 weeks after treatment with 4 mg of baricitinib, based on previously presented 36-week data.

Baricitinib has been approved by the U.S. Food and Drug Administration for use in adults with autoimmune diseases since 2022, and new study results suggest it may be a new option for patients ages 12 to 18 years old. For nearly half of people with severe alopecia areata, the disease begins before adulthood and can progress rapidly, having a significant impact on the sufferer's life. Given the heavy burden of this disease, new treatment options are needed for children and adolescents, a population that has long been underrepresented.

According to the press release,The BRAVE-AA-PEDS study is the largest Phase 3 clinical trial of its kind in adolescents with severe alopecia areata. Severe alopecia areata is defined as a Hair Loss Tool (SALT) score of 50 or higher, indicating at least 50% scalp hair loss.

At baseline examination, enrolled patients demonstrated advanced disease burden, with participants having an average of89% scalp hair loss. Nearly two-thirds (63.8%) were classified as having very severe disease (SALT score of 95-100). At 52 weeks, patients treated with baricitinib demonstrated a significant dose-dependent response, with 54.1% of adolescents treated with baricitinib 4 mg achieving successful scalp hair regrowth, defined as hair coverage of 80% or greater (SALT score ≤20). Additionally, 41.2% of patients in the high-dose cohort achieved near-complete regeneration, characterized by scalp hair coverage of 90% or greater (SALT score ≤10). In contrast, 31% and 26.2% of the 2 mg dose group achieved the endpoints of SALT ≤ 20 and SALT ≤ 10, respectively.

Subset analysis highlights the value of early intervention, suggesting amplified clinical benefits in patients with severe but not complete scalp alopecia. at baselineAmong patients with SALT scores between 50 and 94, 71% of patients taking the 4 mg dose successfully achieved hair regrowth within 1 year.

In addition to the scalp, this study documented meaningful effects in other areas critical to patients’ quality of life and mental health. In the 4 mg dose group, 64.8% of patients observed significant eyebrow regeneration, and 63.3% of patients experienced eyelash regeneration. These data are important because the psychological burden of AA, especially among adolescents, is well documented, and hair loss often leads to high levels of stress and social stigma.

The drug's safety profile for 52 weeks in the adolescent cohort was found to be consistent with established data observed in adult trials for alopecia areata and other indications. 1 The most common treatment-emergent adverse events reported were generally mild and included acne, upper respiratory tract infection, and influenza, and no new safety signals emerged during the study. No opportunistic infections, major adverse cardiovascular events, or venous thromboembolic events were reported.

These promising results in adolescents reinforce what we are seeing in adult clinical practice, which is that early initiation of treatment with baricitinib can lead to higher rates of scalp hair regrowth, including near-complete regeneration in many patients. Systemic treatment of adolescents should not be a last resort, but part of the therapeutic conversation between doctors, caregivers, and patients from the beginning.

References: Updated onNovember 5, 2025, https://www.ajmc.com/view/baricitinib-leads-to-significant-hair-regrowth-in-adolescents-with-severe-alopecia-areata