Baricitinib is first JAK-inhibitor to demonstrate hair regrowth in phase III alopecia areata (AA) trial- Eli Lilly.

Eli Lilly and Company and Incyte announced top-line results from BRAVE-AA2, a Phase III study evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA) . Both doses of baricitinib met the primary efficacy endpoint at Week 36, demonstrating a statistically significant improvement in scalp hair regrowth compared to those randomized to placebo. AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. Baricitinib has received Breakthrough Therapy designation from the FDA for the treatment of AA. This classification aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over already available therapies on a clinically significant endpoint(s). There are currently no FDA-approved treatments for AA. "These positive results are very promising and suggest that baricitinib has the potential to address the urgent needs of people living with alopecia areata," said Brett King, M.D., Ph.D., associate professor of Dermatology at Yale School of Medicine. "This level of high-quality research is needed to advance our understanding and the treatment of this frequently devastating disease." The multicenter, randomized, double-blind, placebo-controlled study included 546 adults with a Severity of Alopecia Tool (SALT) score greater than 50 (i.e., who had greater than 50% scalp hair loss) and a current episode of severe AA lasting at least six months but no more than eight years. The study included a diverse patient population from Argentina, Australia, Brazil, China, Israel, Japan, South Korea, Taiwan and the U.S. Safety outcomes of baricitinib in BRAVE-AA2 were consistent with its established safety profile in patients with rheumatoid arthritis (RA) and atopic dermatitis (AD). No deaths, major adverse cardiovascular events (MACE) or venous thromboembolic events (VTEs) were reported in the study. BRAVE-AA2 is the first Phase III study with positive results in patients with AA. Data from an additional Phase III study of baricitinib in AA will be available in the first half of this year. Detailed results from the BRAVE program will be presented at an upcoming medical conference and published in a peer-reviewed journal later this year. AA is the second potential treatment indication in dermatology for baricitinib after Atopic Dermatitis.