Eli Lilly (Lilly) recently shared 52-week results from its Phase 3 clinical trial examining oral baricitinib (Olumiant®) 4 mg for the treatment of severe alopecia areata in adolescents ages 12 to under 18. The results showed that 71% of adolescents with severe alopecia areata treated with baricitinib 4 mg “achieved successful scalp hair regrowth at one year, with continuous improvements observed throughout those 52 weeks.” Olumiant is currently FDA-approved for the treatment of severe alopecia areata in adults (18 and older). Lilly has reported that it intends to submit the adolescent data to global regulators with the goal of changing its label to include an indication for adolescents. It also plans to enroll the next cohort of children (ages 6 – 12) to the study in the next year. “For nearly half of the people with severe alopecia areata, the disease starts before adulthood and can progress quickly, significantly impacting patients’ lives,” said Nicole Friedland, President and CEO, National Alopecia Areata Foundation (NAAF). “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 also shared final, long-term results from its BRAVE-AA1/BRAVE-AA2 studies, showing that of adults who responded to baricitinib within 52 weeks, 86.5% (taking 4 mg) and 84.7% (taking 2 mg) daily sustained their scalp hair regrowth through approximately four years of treatment. Lilly noted that the safety profile remained consistent up to five years with previous study data. Read the full press release from Lilly.
