Recent clinical trials by Eli Lilly and Incyte show promising results for adolescents aged 12 to 17 with severe alopecia areata, utilizing oral baricitinib. In the BRAVE-AA-PEDS study, significant hair regrowth was observed in participants, with 60% of those on the 4 mg dose achieving at least a 50% improvement by week 36. The treatment also demonstrated effectiveness for eyebrow and eyelash regrowth, with manageable side effects. Baricitinib, approved for adult use in 2022, shows potential as a systemic treatment for alopecia areata.
Promising Results for Alopecia Areata in Adolescents
Recent findings from Eli Lilly and Incyte have highlighted encouraging advancements for adolescents (aged 12 to 17) suffering from severe alopecia areata (AA). In a significant clinical trial, participants treated with oral baricitinib—administered at daily doses of 4 mg and 2 mg—showed remarkable improvements in hair regrowth on their scalps, eyebrows, and eyelashes by week 36. These results were unveiled during the closing session of the American Academy of Dermatology’s annual meeting, which took place from March 7 to 11 in Orlando. Alopecia areata is an autoimmune condition characterized by patchy hair loss, impacting the scalp, face, and sometimes other body areas, with the potential to evolve over time.
Study Insights and Efficacy
Approximately 40% of individuals with alopecia areata first experience symptoms before turning 20. In the BRAVE-AA-PEDS study, a total of 257 participants were randomly assigned to receive either 4 mg of baricitinib, 2 mg of baricitinib, or a placebo once daily. The primary outcome measure was achieving a SALT score (Severity of Alopecia Tool) of 20, indicating 80% or more scalp hair coverage by week 36.
At the commencement of the study, participants exhibited an average scalp hair loss of 89%, with 65% showing minimal to no eyebrow hair and 57% with little to no eyelash hair. By week 36, 60% of those receiving 4 mg of baricitinib and 36.9% of those on 2 mg experienced at least a 50% improvement, as measured by the SALT score, compared to only 5.7% in the placebo group (p = 0.001). Furthermore, 42.4% of participants on the 4 mg dose and 27.4% on the 2 mg dose achieved 80% or more hair coverage, in contrast to 4.5% in the placebo group (p=0.001). Notably, 36.5% of patients on the 4 mg dose and 21.4% on the 2 mg dose achieved 90% or more scalp hair coverage (SALT =10), while only 2.3% of placebo participants did (p=0.001).
The treatment also yielded significant results for eyebrow and eyelash regrowth. Half of the patients on the 4 mg dose achieved considerable eyebrow regrowth, compared to none on placebo (p < 0.01). Additionally, 42.9% saw meaningful eyelash regrowth with the 4 mg dose, while 25.5% on the 2 mg dose showed improvement, compared to 14% on placebo (p=0.002 for 4 mg, p=0.097 for 2 mg). Interestingly, the outcomes for adolescents after 36 weeks were comparable to those of adults after 52 weeks, suggesting a potentially quicker response in younger patients.
The study reported that the most common treatment-related side effects included acne, flu-like symptoms, and upper respiratory infections. Notably, the placebo group experienced a higher rate of serious adverse effects compared to those receiving baricitinib. Importantly, no deaths or severe complications were reported during the trial.
Baricitinib’s safety profile in adolescents aligns with results from previous clinical trials involving juvenile idiopathic arthritis and moderate to severe atopic dermatitis. To date, over 14,600 patients have participated in baricitinib studies, including 866 individuals aged between one month and 17 years. Lilly plans to present further findings from the BRAVE-AA-PEDS study at various scientific forums throughout the year and intends to submit the results for publication in peer-reviewed journals.
Baricitinib, marketed as Olumiant, received FDA approval in 2022 for treating adult patients with severe alopecia areata, marking it as the inaugural systemic treatment authorized in the U.S. for this severe condition. The medication is also approved in the U.S. and over 75 countries for adults with moderately to severely active rheumatoid arthritis and in more than 40 countries for young patients with moderate to severe atopic dermatitis eligible for systemic therapy. Additionally, baricitinib has received marketing authorization for use in hospitalized COVID-19 patients in several nations.