Eli Lilly and Incyte’s oral JAK inhibitor has shown benefit in hair regrowth in paediatric patients with severe alopecia areata.
In the Phase III BRAVE-AA-PEDS trial (NCT05723198) 54.1% and 31% of patients receiving Olumiant (baricitinib) 4mg and 2mg, respectively, achieved successful hair regrowth, defined as 80% or more scalp hair coverage, after 52 weeks. In addition, 41.2% of patients in the high dose cohort and 26.2% in the low dose cohort achieved near-complete scalp hair regrowth, defined as 90% or more scalp hair coverage.
Among those with severe disease, 71% in the high-dose group and 58.6% in the low-dose group achieved successful hair regrowth.
In regard to eyebrow regrowth, improvements in hair coverage were seen in 64.8% of patients receiving Olumiant 4mg and 27.8% of patients receiving Olumiant 2mg. Meanwhile, 63.3% and 34% taking the 4mg and 2mg tablet, respectively, achieved eyelash regrowth.
Based on the Phase III trial, Lilly intends to submit the adolescent data to global regulators for a label update for Olumiant to be used in paediatric patients.
If the label is extended to the trial population, it would be a notable development for paediatric patients, as there is just one approved treatment – Pfizer’s Litfulo (ritlecitinib) – for adolescents aged over 12 with severe alopecia areata. Lilly and Incyte’s drug would provide an option for patients between six and 11 years for which there are currently no treatments.
National Alopecia Areata Foundation (NAAF) president Nicole Friedland said: "For nearly half of the people with severe alopecia areata, the disease starts before adulthood and can progress quickly, significantly impacting patients' lives. 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 trial enrolled 595 children aged between six to under 18 years with severe alopecia areata, as measured by a Severity of Alopecia Tool (SALT) score of ≥50. The safety profile remained consistent within the paediatric population as that reported in adults.
Full data will be presented at the 2025 Fall Clinical Dermatology (FCD) Conference, taking place in Las Vegas between 23 and 26 October.
Olumiant is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly in December 2009.
The therapy was approved by the US Food and Drug Administration in 2022 for adult patients with severe alopecia areata. According to GlobalData’s annual sales and consensus forecast, Olumiant’s sales peaked at $1.15bn in 2021; however, sales started to increase again in 2023, with a 2031 sales forecast of $1.09bn.
GlobalData is the parent company of Clinical Trials Arena.
