Baricitinib effective in adolescents with severe alopecia areata, phase 3 data show

Key takeaways:

• 42.4% of adolescents with severe alopecia areata who received baricitinib had 80% or more scalp hair coverage after 36 weeks.
• An expert said it is the largest trial to date studying treatment in this population.

ORLANDO — Thirty-six weeks of once-daily, oral baricitinib was associated with greater hair regrowth on the scalp, eyebrows and eyelashes compared with placebo in adolescents with severe alopecia areata, data show.

The findings are from the ongoing phase 3 BRAVE-AA-PEDS study that were presented during a late-breaking session at the American Academy of Dermatology Annual Meeting.

Baricitinib (Olumiant, Eli Lilly) is a Janus kinase (JAK) inhibitor that is approved for adults with severe alopecia areata, Thierry Passeron, MD, PhD, professor and chair of the department of dermatology at the Université Côte d'Azur in Nice, France, said during the presentation.

In June 2023, the FDA approved ritlecitinib (Litfulo, Pfizer) for participants with severe alopecia aged 12 years and older, but “there is still a very important medical need” for more options in children and adolescents, Passeron said.

Passeron and colleagues randomly assigned 257 participants aged 12 to younger than 18 years with severe alopecia areata in a 1:1:1 ratio to 2 mg baricitinib daily, 4 mg baricitinib daily or placebo. The primary endpoint was a Severity of Alopecia Tool (SALT) score of 20 or below at 36 weeks, representing 80% or more scalp hair coverage.

At baseline, the mean SALT score was approximately 90% across the treatment groups, indicating “very severe populations,” Passeron said. About 60% of participants were white, one-fourth were Asian, and 6% to 9% were Black or African American. All the participants previously experienced treatment failure with at least one prior therapy.

According to the results, 42.4% of participants in the 4 mg baricitinib group and 27.4% in the 2 mg group achieved the primary endpoint vs. 4.5% of participants in the placebo group. The researchers observed a significant difference between the baricitinib and placebo groups by week 12, Passeron said.

Further, at week 36, the researchers found that 36.5% of participants in the 4 mg baricitinib group and 21.4% in the 2 mg group had a SALT score of 10 or below vs. 2.3% in the placebo group.

Overall, 60% of participants in the 4 mg baricitinib group and 36.9% in the 2 mg group had a 50% or greater improvement in SALT scores compared with 5.7% in the placebo group. Additionally, 32.9% in the 4 mg group and 20.2% in the 2 mg group had a 90% or greater improvement vs. 1.1% in the placebo group.

Baricitinib was also linked to higher rates of eyebrow regrowth at week 36, which was 50% in the 4 mg group and 24.1% in the 2 mg group vs. 0% in the placebo group, as well as eyelash regrowth, which was 42.9% in the 4 mg group and 25.5% in the 2 mg group vs. 14% in the placebo group.

The safety profile of baricitinib was consistent with clinical trials of adolescents with juvenile idiopathic arthritis and moderate to severe atopic dermatitis, according to an Eli Lilly press release. Only one serious adverse event occurred in the baricitinib arms, which was a case of noncomplicated appendicitis in the 4 mg group, Passeron said. The most common treatment-emergent adverse events included acne, headache, upper respiratory infection, rhinitis, nasopharyngitis and influenza.

“There is no new safety signal,” Passeron said.

The BRAVE-AA-PEDS study is ongoing, with additional analyses including children aged 6 to 11 years, according to the press release.