New results from the phase 3 BRAVE-AA-PEDS trial of Lilly’s baricitinib have shown near-complete scalp hair regrowth in adolescents with severe alopecia areata (AA).

AA is an autoimmune condition in which the immune system attacks the hair follicles, causing hair loss. 

The study showed that once-daily oral baricitinib resulted in the majority of patients between 12-18 years being able to regrow hair on the scalp, eyebrows and eyelashes at 52 weeks. 

At the start of the study, patients had an average of 89% scalp hair loss. By 52 weeks, 54.1% of patients receiving baricitinib 4 mg had achieved >80% scalp hair coverage. A high percentage of patients also showed significant eyebrow and eyelash regrowth.

No new safety signals were observed during the year of treatment, and baricitinib’s safety profile for this indication was consistent with its other indications in adults and adolescents.

Nicole Friedland, president and CEO of the National Alopecia Areata Foundation, said: “For nearly half of the people with severe AA, the disease starts before adulthood and can progress quickly, significantly impacting patients' lives. 

“Given the profound burden of this disease, new treatment options are needed for children and adolescents, populations that have been underrepresented for far too long.”

Lilly’s BRAVE-AA1/BRAVE-AA2 studies of adults with severe AA also showed promising results for the ability of baricitinib to stimulate hair regrowth in the long term.

Anabela Cardoso, senior vice president of Lilly Immunology Medical Affairs, said: “If approved, baricitinib could offer an important new option that raises treatment expectations for adolescents living with the profound burden of this disease.”