New Baricitinib AA Data for Adolescents Could Be 'Game-Changing'

Patients ages 12 to under 18 with severe alopecia areata (AA) treated with once-daily, oral baricitinib 4 mg and 2 mg saw clinically meaningful improvements in hair regrowth on the scalp, eyebrows, and eyelashes at Week 36 in the Phase 3 BRAVE-AA-PEDS study, presented as a late-breaker at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.

“What's really exciting about this data is it's adolescent data,” Brittany Craiglow, MD, told Practical Dermatology. “We currently have one FDA-approved option for severe AA and adolescents, and that's ritlecitinib, which is amazing that we have an option, but it's always good to have choice. And we're learning that not every patient responds to these medications, but failure of one doesn't mean failure of another, necessarily, which is great. Also, what baricitinib brings to the table is a real legacy of safety that, as someone who treats a lot of children, is really reassuring. It is approved in 40-plus countries for other pediatric indications. There is a whole body of safety literature in kids. JAK inhibitors are really exciting for everybody, but the concern that often holds people back is safety, so when you have a drug that has this legacy it can give more comfort or confidence to people when prescribing.”

In the BRAVE-AA-PEDS study, 257 patients were randomized to receive once-daily baricitinib 4 mg, baricitinib 2 mg, or placebo. The primary endpoint of this study was a Severity of Alopecia Tool (SALT) score ≤20 (ie, 80% or more scalp hair coverage) at Week 36. At the start of the study, patients had an average of 89% scalp hair loss (near total hair loss), 65% had minimal or no eyebrow hair (clinician-reported outcome [ClinRO] score of 2 or 3), and 57% had minimal or no eyelash hair (ClinRO score of 2 or 3).

At Week 36: 

• 60.0% of patients receiving baricitinib 4 mg and 36.9% of patients receiving baricitinib 2 mg saw at least a 50% improvement in their disease (as measured by SALT score) compared to 5.7% on placebo (p=0.001). 

• 42.4% of patients receiving baricitinib 4 mg and 27.4% of patients receiving baricitinib 2 mg achieved 80% or more scalp hair coverage, compared to 4.5% on placebo (p=0.001). 

• 36.5% of patients receiving baricitinib 4 mg and 21.4% of patients receiving baricitinib 2 mg had 90% or more scalp hair coverage (SALT ≤10), compared to 2.3% on placebo (p=0.001).  

• 50.0% of patients receiving baricitinib 4 mg and 24.1% of patients receiving baricitinib 2 mg achieved significant eyebrow regrowth (ClinRO scores of 0 or 1 with a ≥2 point improvement from baseline) compared to 0% on placebo (p<0.01). 

• 42.9% of patients receiving baricitinib 4 mg achieved significant eyelash regrowth, and 25.5% receiving baricitinib 2 mg saw improved eyelash regrowth, compared to 14.0% on placebo (p=0.002 for 4 mg, p=0.097 for 2 mg).1  

“The efficacy is really exciting,” Dr. Craiglow said. “We're not meant to compare clinical trials, but it looked even better than the adult data. It was a trial of severe alopecia areata, so everybody had to have at least 50% hair loss, and the average SALT score was around 90. The primary endpoint was at 36 weeks, and more than 40% of patients achieved a SALT score of 20 or less. That is a lot of patients, and we know from other trial data, that often if you give people more time, then more patients actually achieve that endpoint. So this is really exciting for our patients because efficacy looks great, and in real life we often can do better than clinical trials because we don't have to use monotherapy. In my clinical practice, I often combine these drugs with oral minoxidil, which often gives us little boost in efficacy. So this just means that, ultimately, more patients will be treated effectively. It sounds corny, but more lives will be changed.”

This was the largest clinical trial in adolescents with severe AA to date, Dr. Craiglow said.

“Ritlecitinib included adolescents from the beginning with adults in their clinical trial program, so that was a smaller proportion of their patients,” she said. “This is just a really robust unit, and again, really severe patients. Thinking about the real world, we know that patients with less severe disease tend to respond better.”

The efficacy results were particularly encouraging because of AA’s psychological impact specifically on children, Dr. Craiglow said.

“I think we can all think back on our middle school years, and you couldn’t pay us enough to revisit that even if we didn’t have alopecia areata,” she said. “These kids often withdraw socially. They stop doing things that they always did. It truly is life altering. To have another potential therapeutic option is game-changing, really.”

The next step will be the 52-week and long-term extension data, and Dr. Craiglow said she is comfortable based on the safety profile that has been established for baricitinib in adults with alopecia areata.

“I really look forward to it hopefully being approved,” she said.