Core Messages
Two phase 3 studies, each running for 36 weeks, have proven the efficacy of the Janus kinase inhibitor baricitinib (Olumiant) for patients with alopecia areata. Almost a quarter of participants achieved the therapeutic aim of 80% hair coverage at the low dose, while this figure was significantly more than one third for the high dose.
Background
Patchy hair loss (alopecia areata) is a relapsing autoimmune disease that can only be treated (inadequately) with the topical use of steroids or immunosuppressants. One new approach is the relatively specific inhibition of the interferon gamma and interleukin 15 cytokines with baricitinib, a Janus kinase inhibitor, which has already been used off-label many times.
Design
The two randomized, placebo-controlled, phase 3 studies BRAVE-AA1 and BRAVE-AA2 included 654 adult patients. The average age was about 38 years, and women accounted for 60% of the population. The duration of illness was about 12 years, and the current episode had lasted 4 years. The studies were designed by the sponsor, Eli Lilly, and the inclusion criteria were upper age limits of 60 years for men and 70 years for women, aiming to limit the risk of extensive androgenic alopecia. In addition, patients had to have a severity of at least 50 out of 100 points on the Severity of Alopecia Tool (SALT).
