Baricitinib Shows Significant Hair Regrowth for Pediatric Patients With Alopecia Areata
Patients aged 12 to under 18 saw clinically meaningful regrowth on the scalp, eyebrow, and eyelashes with both high-dose and low-dose treatment.
Patients aged 12 to under 18 years who have severe alopecia areata (AA) saw clinically meaningful improvements in hair regrowth on the scalp, eyebrows, and eyelashes at 36 weeks with once daily treatment of baricitinib 4 mg and 2 mg, according to data from the phase 3 BRAVE-AA-PEDS study. The data were presented as a late-breaking presentation at the American Academy of Dermatology Annual Meeting in Orlando, Florida, from March 7 to 11, 2025.1
The data were presented as a late-breaking presentation at the American Academy of Dermatology Annual Meeting in Orlando, Florida from March 7 to 11, 2025. | Image Credit: Dmytro Furman | stock.adobe.com
"Early onset alopecia areata can be more severe, leading to extensive hair loss that frequently does not improve with topicals or corticosteroids often prescribed as first-line therapy," Brittany Craiglow, MD, adjunct associate professor of dermatology at Yale School of Medicine, said in a news release.1 "These initial results are exciting because they demonstrate that baricitinib can provide significant hair regrowth for adolescents at 36 weeks, a promising early signal of baricitinib's potential as an effective treatment for adolescents with severe disease."
Investigators of the study aimed to determine the efficacy and safety of baricitinib for the treatment of severe or very severe AA for adolescents. It was divided into 4 periods—a 5-week screening period, a 36-week, double-blind treatment period, a 2-year long-term extension period, and a 4-week post-treatment period. Patients had a diagnosis of at least 1 year, with a current AA episode of at least 6 months, and a history of trial and failure with at least 1 available treatment, according to the clinical trial information. Patients received either high-dose baricitinib (4 mg), low-dose baricitinib (2 mg), or the placebo.2
The primary outcome included the percentage of individuals achieving an absolute severity of alopecia tool (SALT) of 20 or less at week 36. The secondary outcome included percent change from baseline in SALT score, percentage of patients achieving at least 90% improvement from baseline, percentage of patients with patient-reported outcome from scalp hair assessment score of 0 or 1, percentage of individuals achieving clinician-reported outcome measures for eyebrow hair loss, and percentage of patients achieving clinician-reported outcome measures for eyelash hair loss at week 36.2
There were 257 patients randomized to receive one of the treatment options, with individuals having an average of 89% scalp hair loss, 65% having minimal or no eyebrow hair, and 57% having minimal or no eyelash hair. At 36 weeks, investigators found that 60% of patients receiving the high-dose treatment and 36.9% of those receiving the low-dose treatment had at least 50% improvement in the disease compared with 5.7% on the placebo. Further, 42.4% of patients and 27.4% of patients, respectively, achieved 80% of more scalp hair coverage compared with 4.5% with the placebo.1
For eyebrow regrowth, 50% of patients receiving high-dose baricitinib and 24.1% receiving low-dose baricitinib had significant eyebrow regrowth compared with 0% for the placebo, and 42.9% and 25.5%, respectively, had improved eyelash regrowth compared with 14% with the placebo.1
The most common treatment-emergent adverse events included acne, influenza, and upper reparatory tract infection.1
"With these data, baricitinib is the most well-studied JAK inhibitor in severe alopecia areata, a chronic immune system disorder that can have an especially devastating social and emotional impact on adolescent patients and their families," Anabela Cardoso, senior vice president at Lilly Immunology Medical Affairs, said in the news release.1 "We are excited about these initial results, which show baricitinib can provide significant scalp hair regrowth in adolescents, potentially at an even faster rate compared to adults.”
