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. 2023 Dec;13(12):3181-3191.
doi: 10.1007/s13555-023-01033-8. Epub 2023 Sep 23.

Efficacy of Baricitinib in Patients with Various Degrees of Alopecia Areata Severity: Post-Hoc Analysis from BRAVE AA1 and BRAVE AA2

Susan Taylor  1 , Neil J Korman  2 , Tsen-Fang Tsai  3 , Yutaka Shimomura  4 , Meghan Feely  5   6 , Yves Dutronc  5 , Wen-Shuo Wu  5 , Najwa Somani  5 , Antonella Tosti  7
Affiliations

Efficacy of Baricitinib in Patients with Various Degrees of Alopecia Areata Severity: Post-Hoc Analysis from BRAVE AA1 and BRAVE AA2

Susan Taylor et al. Dermatol Ther (Heidelb). 2023 Dec.

Abstract

Background: Baricitinib, an oral selective JAK1/JAK2 inhibitor, is approved for the treatment of adults with severe alopecia areata (AA).

Objective: To evaluate differences in response up to week 52 among subgroups based on the baseline severity of AA assessed with the Severity of Alopecia Tool (SALT) score.

Methods: Data were pooled from BRAVE-AA1 and BRAVE-AA2, two randomized, placebo-controlled, phase 3 trials, which enrolled adults with a SALT score ≥ 50. Patients were subdivided by the degree of AA severity at baseline.

Results: Among the 855 patients treated with baricitinib 2 mg and 4 mg, improvements in scalp hair growth continued through to week 52. A superior response was observed in patients with a SALT score of 50-94 versus a score of 95-100. Patients on baricitinib 4 mg had a faster and higher response rate compared to baricitinib 2 mg.

Conclusion: Across all degrees of severity for baricitinib 2 mg and 4 mg doses, the proportion of patients responding was yet to plateau up to week 52. Response to treatment was longer for patients with a baseline SALT score 95-100. Further studies are needed to analyze other parameters that may impact observed response rates.

Keywords: Adults; Alopecia areata; Alopecia totalis; Alopecia universalis; Baricitinib; Clinician-reported outcome; Efficacy; Hair loss; Janus kinase; Randomized; Severity of alopecia tool.

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Conflict of interest statement

Susan Taylor is an employee and is on the board of directors of Mercer Strategies. Susan Taylor is also a speaker for Beiersdorf, Inc., Evolus, Inc, MJH LifeSciences, and L'Oréal USA. Susan Taylor is on the advisory board for Beiersdorf, Inc., Biorez, Inc., Galderma Laboratories, L.P., GloGetter, Hugel America, Inc., Janssen, L'Oréal USA, Medscape/WebMD, Scientis US, and UCB. Susan Taylor is a consultant for Arcutis Biotherapeutics, Inc., Armis Scientific, Beiersdorf, Inc., Cara Therapeutics, Cara Therapeutics, Evolus, Inc., Johnson & Johnson Consumer Products Company, Piction Health, Regeneron, Vichy Laboratoires. Susan Taylor is an author for McGraw-Hill, and is on the editorial board for Practical Dermatology, Cutis, and Archives in Dermatologic Research. ST is also a peer reviewer for the British Journal of Dermatology and an investigator for Concert Pharmaceuticals, Croma-Pharma, Eli Lilly, and Pfizer. Neil J. Korman reported receiving grants and personal fees from AbbVie, Eli Lilly, Leo Pharma, Principia, and Trevi; grants from Amgen, Celgene, Chemocentryx, Dermira, Menlo Therapeutics, Syntimmune, and XBiotech; and personal fees from Genentech, Janssen, Novartis, Regeneron, Sun Pharma, and UCB. Tsen-Fang Tsai has conducted clinical trials or received honoraria for serving as a consultant for AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, GSK-Stiefel, Janssen-Cilag, Leo Pharma, Merck, Novartis, Pfizer Inc., and UCB Pharma. Yukata Shimomura receives advisory fees from Eli Lilly Japan K.K. and Maruho Co. YS also receives research grants for studies not related to this work from Eli Lilly Japan K.K., Maruho Co., and Sun Pharma Japan Ltd. Meghan Feely is an associate staff member at: Mount Sinai Hospital; is a current employee and shareholder of: Eli Lilly and Company; has received consulting, travel, or speaker fees from: American Academy of Dermatology, Aerolase, Castle Biosciences, CeraVe—L'Oréal, DREAM USA, Galderma Aesthetics, Glow Recipe, La Roche-Posay—L'Oréal, Revian, Sonoma Pharmaceuticals, Sun Pharma, and Suneva Medical. Yves Dutronc, Wen-Shuo Wu, and Najwa Somani are employees, and shareholders of Eli Lilly and Company. Antonella Tosti is a compensated consultant/advisory board member for Eli Lilly, the sponsor of the study. Antonella Tosti is also a consultant for DS Laboratories, Monat Global, Almirall, Tirthy Madison, P&G, Pfizer, Myovant, Bristol Myers Squibb, Curallux LLC, and PI for Eli Lilly, Concert, and Erconia.

Figures

Fig. 1
Fig. 1
Distribution of baseline SALT score across baricitinib 2 mg and 4 mg treatment arms
Fig. 2
Fig. 2
SALT score of 10 or less through to Week 52, in degrees of AA severity. Primary censoring rule excludes data collected after permanent study drug discontinuation or data collected at remote visits because of the COVID-19 pandemic. SALT score ≤ 10 =  ≤ 10% improvement from the patient’s baseline SALT score
Fig. 3
Fig. 3
SALT Score of 20 or less through to Week 52, in degrees of AA severity. Primary censoring rule excludes data collected after permanent study drug discontinuation or data collected at remote visits because of the COVID-19 pandemic. SALT score ≤ 20 =  ≤ 20% improvement from the patient’s baseline SALT score
Fig. 4
Fig. 4
A 50% reduction in SALT score through to Week 52, in degrees of AA severity. Primary censoring rule excludes data collected after permanent study drug discontinuation or data collected at remote visits due to the COVID-19 pandemic. SALT50 = 50% improvement from the patient’s baseline SALT score
See this image and copyright information in PMC

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