A phase 3 study evaluating baricitinib in adult patients with severe alopecia areata met its primary end point of hair regrowth across 2 dosing regimens.
BRAVE-AA2 (ClinicalTrials.gov: NCT03899259) is a multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of baricitinib in adults with severe alopecia areata (n=546). The study included patients with a Severity of Alopecia Tool (SALT) score of at least 50 (≥50% scalp hair loss) and a current episode of severe alopecia areata lasting at least 6 months but less than 8 years.
Patients were randomly assigned to receive either baricitinib 2mg once daily, baricitinib 4mg once daily, or placebo. The primary end point was the percentage of patients achieving SALT score of less than or equal to 20 at week 36.
Both doses of baricitinib met the primary end point, demonstrating statistically significant improvement in scalp hair regrowth compared with placebo. The safety profile of baricitinib in alopecia areata patients was consistent with its established profile in rheumatoid arthritis and atopic dermatitis. No deaths, major adverse cardiovascular events or venous thromboembolic events were reported.
Detailed study data will be presented at an upcoming medical congress and published in a peer-reviewed journal later this year. “We are looking forward to sharing the totality of data from the overall clinical development program for baricitinib as a potential first-in-disease treatment for alopecia areata,” said Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly.
Baricitinib, an oral Janus kinase (JAK) inhibitor, is marketed under the trade name Olumiant and is currently indicated for the treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response to 1 or more tumor necrosis factor antagonist therapies.
Baricitinib is first JAK-inhibitor to demonstrate hair regrowth in phase 3 alopecia areata (AA) trial. [press release]. Indianapolis, IN: Eli Lilly, Incyte; March 3, 2021.