Efficacy and safety of the oral Janus kinase inhibitor baricitinib in the treatment of adults with alopecia areata: Phase 2 results from a randomized controlled study.

There are no treatments approved by the Food and Drug Administration for alopecia areata. To evaluate the efficacy and safety of baricitinib in patients with ≥50% scalp hair loss in a phase 2 study of adults with alopecia areata (BRAVE-AA1). Patients were randomized 1:1:1:1 to receive placebo or baricitinib 1 mg, 2 mg, or 4 mg once daily. Two consecutive interim analyses were performed after all patients completed weeks 12 and 36 or had discontinued treatment prior to these time points. The primary endpoint was the proportion of patients achieving a Severity of Alopecia Tool (SALT) score ≤20 at week 36. Logistic regression was used with nonresponder imputation for missing data. A total of 110 patients were randomized (placebo, 28; baricitinib 1-mg, 28; 2-mg, 27; 4-mg, 27). The baricitinib 1-mg dose was dropped after the first interim analysis based on lower SALT Small sample size limits generalizability of results. These results support the efficacy and safety of baricitinib in patients with ≥50% scalp hair loss.

Copyright © 2021 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Conflicts of interest Dr King is an investigator for Concert Pharmaceuticals Inc, Eli Lilly and Company, and Pfizer Inc; is a consultant and/or has served on advisory boards for Aclaris Therapeutics, Arena Pharmaceuticals, Bristol-Meyers Squibb, Concert Pharmaceuticals Inc, Dermavant Sciences, Eli Lilly and Company, Pfizer Inc, TWi Biotechnology Inc, and Viela Bio; and is on the speaker's bureau for Regeneron and Sanofi Genzyme. Dr Ko served as a clinical investigator and/or consultant for AbbVie, Sanofi, Regeneron, Dermira, BMS, Arena, and Eli Lilly. Dr Forman is a consultant, investigator, advisory board member, and/or speaker for and receives funding and/or honoraria from AbbVie, Aclaris Therapeutics Inc, Asana BioSciences, AstraZeneca, Athenex, Celgene Corporation, Cutanea Life Sciences, Eli Lilly and Company, Incyte Corporation, Innovaderm Research Inc, Novartis, Pfizer Inc, Promius Pharma LLC, Regeneron, UCB, Valeant Pharmaceuticals North America LLC, and XBiotech. Dr Ohyama received advisory fees from Eli Lilly Japan, Pfizer Japan Inc, Taisho Pharmaceutical Co, and RHOTO Pharmaceutical Co; and research grants not related to the current work from Maruho Co and Shiseido Co. Dr Mesinkovska served as an advisory board member for Nutrafol, Lilly, Concert, and Arena. Drs Yu, McCollam, Holzwarth, and Dutronc and authors Janes and Edson-Heredia are employees and shareholders of Eli Lilly and Company. Dr Gamalo was an employee of Eli Lilly and Company and is a current employee and shareholder of Pfizer.