Lilly's Baricitinib Promotes Hair Regrowth in Adolescents with Severe Alopecia Areata

Recent findings from a study presented at the American Academy of Dermatology Annual Meeting have highlighted significant progress in the treatment of alopecia areata (AA) in adolescents. The study, conducted by Eli Lilly and Company along with Incyte, focused on adolescents aged 12 to under 18 with severe AA. The results are promising, demonstrating remarkable hair regrowth on the scalp, eyebrows, and eyelashes after 36 weeks of treatment with baricitinib, an oral medication.

Alopecia areata is an autoimmune condition characterized by patchy hair loss, primarily affecting the scalp and potentially other parts of the body. It often begins at a young age, with around 40% of patients experiencing its onset before the age of 20. Traditional treatment methods, such as topical solutions and corticosteroids, frequently fall short in managing the condition, especially in severe cases. This has led to a pressing need for more effective treatment options.

The Phase 3 BRAVE-AA-PEDS study enrolled 257 adolescents who were randomized to receive either 4 mg or 2 mg of baricitinib or a placebo, administered once daily. The study's primary endpoint was achieving a Severity of Alopecia Tool (SALT) score of 20 or less, indicating at least 80% scalp hair coverage at week 36. The initial conditions of these patients were severe, with an average 89% scalp hair loss and significant loss of eyebrow and eyelash hair.

By week 36, the outcomes were remarkable: 60% of patients taking 4 mg of baricitinib and 36.9% of those on 2 mg experienced a 50% or more improvement in their SALT score, compared to just 5.7% of those on placebo. In terms of achieving 80% or more scalp hair coverage, the 4 mg group showed a success rate of 42.4%, while the 2 mg group was at 27.4%, significantly higher than the placebo group at 4.5%. Moreover, 36.5% of those on 4 mg and 21.4% on 2 mg achieved 90% or more scalp hair coverage, compared to a mere 2.3% with placebo.

The eyebrow and eyelash regrowth results were also notable. Half of the patients on the 4 mg dose achieved significant eyebrow regrowth, with no improvement seen in the placebo group. Eyelash regrowth was significant in 42.9% of the 4 mg group, compared to 14% in the placebo group.

The study's findings suggest that adolescents may experience faster hair regrowth compared to adults, with data supporting baricitinib as a potent treatment option for severe alopecia areata. Anabela Cardoso, senior vice president of Lilly Immunology Medical Affairs, expressed optimism regarding the potential of baricitinib, emphasizing its significance for adolescents suffering from the social and emotional impacts of this chronic condition.

Safety data from the study indicated that the most common adverse events were acne, influenza, and respiratory infections. Interestingly, serious adverse events were less frequent in the baricitinib groups compared to the placebo. The safety profile for adolescents aligns with previous findings in juvenile idiopathic arthritis and moderate-to-severe atopic dermatitis treatments.

Eli Lilly plans to continue sharing further data from this study throughout the year, with intentions to submit results for peer-reviewed publication. Baricitinib, marketed as Olumiant, has been approved in the U.S. for adults with severe AA and is being evaluated for use in younger populations. It is also approved for other conditions, including rheumatoid arthritis and atopic dermatitis, across numerous countries worldwide.

These advancements in treatment options represent a significant step forward for adolescents grappling with severe alopecia areata, offering hope for improved quality of life and emotional well-being.