The US FDA expanded baricitinib labeling to severe alopecia areata in patients aged ≥12 years, creating an on-label systemic option for adolescents previously managed off-label.
Eli Lilly announced that the FDA has expanded the US approval of baricitinib (Olumiant) to include patients aged 12 years and older with severe alopecia areata. The oral Janus kinase (JAK) inhibitor was previously approved for adults with severe alopecia areata; the expanded indication gives clinicians another systemic treatment option to discuss with adolescents and families.¹
The decision rests on 36-week results from BRAVE-AA-PEDS, a phase 3 trial conducted specifically in adolescents with severe disease. “The evidence supporting Olumiant’s approval is particularly meaningful because it comes from a Phase 3 study specifically designed for pediatric patients,” Brittany Craiglow, MD, adjunct associate professor of dermatology at Yale School of Medicine, said in the company’s announcement.¹
BRAVE-AA-PEDS enrolled patients aged 12 to younger than 18 years who weighed at least 30 kg, had lost at least 50% of scalp hair, and had experienced a current severe episode for 6 months to 8 years. In its placebo-controlled cohort, 257 adolescents were randomized equally to once-daily baricitinib 4 mg, baricitinib 2 mg, or placebo. A second cohort of 166 adolescents received one of the active doses to add safety data. The primary endpoint was a Severity of Alopecia Tool (SALT) score of 20 or less at week 36, corresponding to no more than 20% scalp hair loss.¹
At baseline, the median SALT score was 100, indicating complete scalp hair loss, and the mean duration of alopecia areata was 6.4 years. At week 36, 42% of patients receiving 4 mg and 27% receiving 2 mg reached SALT 20 or less, compared with 5% receiving placebo. SALT 10 or less was achieved by 37%, 21%, and 2%, respectively. Lilly also reported improved eyebrow and eyelash coverage with 4 mg among patients with substantial loss in those areas at baseline, but did not provide corresponding response percentages in its announcement.¹
Alopecia areata is an immune-mediated cause of hair loss that can begin in childhood. A population-based study estimated lifetime incidence at 2.1%, while a systematic review described its epidemiology and burden, including disease in younger patients.³,⁴ For adolescents with extensive scalp loss, the visible nature and unpredictable course of the condition can add to treatment decisions already complicated by the need to weigh potential benefit against prolonged drug exposure.
Baricitinib was first approved in the US for adults with severe alopecia areata in 2022, according to Lilly. Its other reported US uses include rheumatoid arthritis in adults after an inadequate response or intolerance to a tumor necrosis factor blocker, and treatment of hospitalized adults with COVID-19. The company reported European approval for adolescents with severe alopecia areata in April 2026.¹
The recommended alopecia areata dose is 2 mg daily, with an increase to 4 mg if response is inadequate. The labeling also allows clinicians to consider starting at 4 mg for patients with nearly complete or complete scalp hair loss, followed by a decrease to 2 mg after an adequate response.²
Safety remains central to shared decision-making. Lilly described the adolescent safety profile as consistent with that seen in adults with severe alopecia areata, but its announcement did not provide pediatric adverse-event rates. The US labeling carries boxed warnings for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. It also calls for tuberculosis assessment and laboratory monitoring; risks identified largely in older adults should not be assumed to occur at the same rate in adolescents.¹,²
The reported endpoint establishes a short-term scalp-hair response, not whether regrowth persists after treatment stops. BRAVE-AA-PEDS is ongoing, and longer follow-up will be important for assessing durability and safety. The approval does not extend to children younger than 12 years.¹,²
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