In the phase 3 BRAVE-AA-PEDS trial, baricitinib (Olumiant; Eli Lilly), an oral Janus kinase (JAK) 1/2 inhibitor, showed significant hair regrowth on the scalp, eyelashes, and eyebrows after 52 weeks in adolescents with severe alopecia areata.
The study (NCT05723198) reported that 71% of adolescents treated with baricitinib 4 mg experienced successful scalp hair regrowth at one year, improving on earlier 36-week results.
Baricitinib has been FDA-approved for adults with this autoimmune condition since 2022. These new findings suggest it could become a treatment option for patients aged 12 to under 18 years.
"For nearly half of the people with severe alopecia areata, the disease starts before adulthood and can progress quickly, significantly impacting patients' lives," said Nicole Friedland, president and CEO of the National Alopecia Areata Foundation (NAAF).
"Given the profound burden of this disease, new treatment options are needed for children and adolescents, populations that have been underrepresented for far too long."
The BRAVE-AA-PEDS trial is the largest phase 3 clinical study focused solely on adolescents with severe alopecia areata.
Baricitinib demonstrates promising effectiveness in restoring hair for adolescents with severe alopecia areata, marking a potential new therapeutic option for this underserved age group.