Outcomes of down-titration in patients with severe scalp alopecia areata initially treated with baricitinib 4-mg: Week 152 data from BRAVE-AA2.

Background: Baricitinib, an oral selective Janus kinase inhibitor, is approved to treat adults with severe alopecia areata (AA).
Objective: To report the week 152 efficacy results from the phase 3 trial BRAVE-AA2 down-titration substudy.
Methods: BRAVE-AA2 enrolled 546 adults with severe AA (Severity of Alopecia Tool [SALT] score ≥50). Baricitinib 4-mg-treated patients achieving a clinical response (SALT score ≤20) at week 52 were rerandomized 1:1 to stay on 4-mg or down-titrate to 2-mg. The last observation carried forward was used to impute missing or censored data.
Results: At week 52, 86/234 (36.8%) baricitinib 4-mg-treated patients were eligible for down-titration; 44 remained on 4-mg while 42 down-titrated to 2-mg. At week 152, 39/44 (88.6%) 4-mg-treated patients had maintained clinical response, compared to 24/41 (58.5%) down-titrated patients. Among down-titrated patients, loss of treatment benefit was less frequent in those with sustained response and SALT score ≤5 at week 52.
Limitations: Method and timing of down-titration were prespecified in the protocol based on week 52 responder status and not on other clinical factors.
Conclusion: More than half of down-titrated patients maintained response. Sustained treatment response and/or near-total regrowth may be associated with a greater likelihood of response maintenance after down-titration.
Competing Interests: Conflicts of interest Dr King is a clinical trial investigator for Abbvie, Eli Lilly and Company, Incyte, Pfizer Inc, Regeneron, and Sanofi Genzyme; is a consultant or is on the advisory board for Abbvie, AltruBio Inc, Almirall, AnaptysBio, Arena Pharmaceuticals, Aslan Pharmaceuticals, BiologicsMD, Bristol Meyers Squibb, Concert Pharmaceuticals Inc, Equillium, Horizon Therapeutics, Eli Lilly and Company, Incyte Corp, Janssen Pharmaceuticals, LEO Pharma, Merck, Otsuka/Visterra Inc, Pfizer Inc, Q32 Bio Inc, Regeneron, Sanofi Genzyme, Sun Pharmaceutical Industries, TWi Biotechnology Inc; is on the data monitoring committee for Incyte Corp, Ventyx Biosciences Inc; is on speakers bureaus for Abbvie, Eli Lilly and Company, Incyte, Pfizer Inc, Regeneron, Sanofi Genzyme; and receives travel support from Pfizer, Eli Lilly and Company, Sun Pharmaceuticals. Dr Ohyama is a consultant or is on the advisory board for AbbVie GK, Bristol Myers Squibb Japan, Eli Lilly and Company, Maruho Pharmaceutical Co, Pfizer Inc, ROHTO Pharmaceutical Co, Taisho Pharmaceutical Co; is an editor at The Journal of Dermatology; reports honoraria/speakers bureaus for Eli Lilly and Company, Pfizer Inc; receives research grant from Shiseido Co, Maruho Co, Advantest Corp., Sun Pharma Japan Ltd; and receives travel support from Pfizer Inc. Dr Senna is a consultant or is on the advisory board for Abbvie, Eli Lilly and Company, Pfizer Inc, Arena, Cassiopia, Inmagene, Kintor, LOreal; is on the data monitoring committee for Abbvie, Eli Lilly and Company, Pfizer Inc; reports honoraria/speakers bureaus for Eli Lilly and Company, Pfizer Inc; receives travel support from Eli Lilly and Company, Pfizer Inc. Dr Shapiro is a consultant or is on the advisory board for Pfizer Inc, Eli Lilly and Company; Drs Dutronc, Durand, Yu, Kolodsick, and Chiasserini are employees and shareholders of Eli Lilly and Company. Dr Liu is an employee of Tigermed-BDM, Inc. Dr Piraccini is a consultant or is on the advisory board for Difa Cooper, Ducrey, Eli Lilly and Company, LOreal, Pfizer, Inc; reports honoraria/speakers bureaus for Difa Cooper, Ducrey, Eli Lilly and Company, LOreal, Pfizer, Inc. Dr Somani has no conflicts of interest to declare.
(Copyright © 2024. Published by Elsevier Inc.)