Long-Term Baricitinib Data Reinforce Potential in Adolescents With AA
More than half of adolescents treated for alopecia areata (AA) with baricitinib 4mg achieved successful scalp hair response by Week 52, with a response rate reaching 71% among those with baseline Severity of Alopecia Tool (SALT) score of 50-94, according to new data presented at the 2025 Fall Clinical Dermatology Conference in Las Vegas.
The BRAVE-AA-PEDS is the largest ongoing placebo-controlled, phase 3 trial of pediatric participants with severe AA (SALT ≥50), according to the clinical investigators. Successful regrowth was also observed with baricitinib 2mg. No new safety observation was reported and the safety profile of baricitinib remained consistent with previous reports.
“These are the longest-term results we've had in adolescents,” investigator Brittany G. Craiglow, MD, said, noting that 52 weeks is a meaningful timeframe given the slow nature of hair regrowth.
Outcomes were especially encouraging in those with severe but not complete scalp hair loss.
“This reinforces a pattern we’ve been observing: patients with some hair at baseline tend to have better outcomes, and if we treat before complete hair loss, we can potentially alter their disease course,” Dr. Craiglow said.
The response rate among adolescents with very severe disease (95–100% scalp hair loss) was also meaningful, though lower than in those with partial scalp involvement.
The adolescent population deserves special focus, Dr. Craiglow noted, not only because of disease severity but also due to the psychosocial burden at this developmental stage.
“Alopecia areata is devastating at any age, but for adolescents—who are forming their identity and navigating social interactions—hair loss can be especially traumatic,” she said.
Dr. Craiglow cited experiences of bullying, withdrawal from social and school activities, and long-term emotional impact as common consequences of untreated disease.
“We know that some children don’t regrow hair spontaneously, even after many years,” she said. “If a 12-year-old hasn’t had hair since they were seven, we may be looking at a permanent loss if we don’t intervene.”
Baricitinib is not yet approved for use in adolescents with alopecia areata in the United States, though it has approval in other pediatric indications in more than 40 countries, including for juvenile idiopathic arthritis and atopic dermatitis. This international pediatric experience provides added reassurance on long-term safety.
“Parents are understandably focused on safety,” Dr. Craiglow said. “Baricitinib carries a legacy of pediatric use, which can be reassuring if it gains approval for alopecia in this population.”
Dr. Craiglow cautioned that a single JAK inhibitor may not work for everyone.
“We recently published data showing that patients who fail one JAK inhibitor can still respond to another. These drugs are not interchangeable for every patient,” she said. “Having multiple tools in our arsenal is critical to changing more lives.”