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Clinical Trial
. 2021 Aug;85(2):379-387.
doi: 10.1016/j.jaad.2021.03.050. Epub 2021 Mar 20.

A phase 2a randomized, placebo-controlled study to evaluate the efficacy and safety of the oral Janus kinase inhibitors ritlecitinib and brepocitinib in alopecia areata: 24-week results

Brett King  1 , Emma Guttman-Yassky  2 , Elena Peeva  3 , Anindita Banerjee  3 , Rodney Sinclair  4 , Ana B Pavel  2 , Linda Zhu  3 , Lori Ann Cox  5 , Brittany Craiglow  6 , Linda Chen  7 , Christopher Banfield  3 , Karen Page  3 , Weidong Zhang  3 , Michael S Vincent  3
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Free article
Clinical Trial

A phase 2a randomized, placebo-controlled study to evaluate the efficacy and safety of the oral Janus kinase inhibitors ritlecitinib and brepocitinib in alopecia areata: 24-week results

Brett King et al. J Am Acad Dermatol. 2021 Aug.
Free article

Abstract

Background: Alopecia areata (AA) is an autoimmune form of hair loss with limited treatments.

Objective: To evaluate the efficacy and safety of the Janus kinase inhibitors ritlecitinib and brepocitinib in patients who have AA with ≥ 50% scalp hair loss.

Methods: Patients were randomized to once-daily ritlecitinib, brepocitinib, or placebo. The primary efficacy endpoint was a 24-week change from baseline in the Severity of Alopecia Tool (SALT) score. The key secondary efficacy endpoint was the proportion of patients achieving 30% improvement in SALT score (SALT30).

Results: The ritlecitinib, brepocitinib, and placebo groups included 48, 47, and 47 patients, respectively. At week 24, least-squares mean difference from placebo in SALT score change from baseline was 31.1 (95% confidence interval [CI], 18.8-43.5) for ritlecitinib and 49.2 (95% CI, 36.6-61.7) for brepocitinib (P < .0001 for both comparisons with placebo). SALT30 was achieved by 50% (90% CI, 38%-62%) of patients receiving ritlecitinib, 64% (90% CI, 51%-75%) receiving brepocitinib, and 2% (90% CI, 0%-9%) receiving placebo. Two patients experienced a serious adverse event (rhabdomyolysis) in the brepocitinib group only.

Limitations: Only a single-dosage regimen of each study drug was included.

Conclusion: Treatment with ritlecitinib or brepocitinib for 24 weeks was efficacious and generally well tolerated.

Keywords: Janus kinase inhibitor; alopecia areata; brepocitinib; efficacy; phase 2; ritlecitinib; safety.

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Conflict of interest statement

Conflicts of interest Dr King is a clinical trial investigator for Pfizer, Concert Pharmaceuticals, and Eli Lilly and Company and has received honoraria and/or consulting fees from Aclaris Therapeutics, Arena Pharmaceuticals, Bristol-Meyers Squibb, Celgene, Concert Pharmaceuticals, Dermavant Sciences, Eli Lilly and Company, Pfizer, Regeneron, and Sanofi Genzyme. Dr Guttman-Yassky has received institutional grants from AbbVie, Celgene, Eli Lilly, Janssen, Dermavant, DS Biopharma, Novartis, Pfizer, Regeneron, Glenmark, Galderma, Asana Biosciences, Innovaderm, Dermira, LEO Pharma, Novan, Kyowa Kirin, Concert, Union Therapeutics, and Ralexar and is a consultant for Sanofi, Regeneron, Celgene, Dermira, Galderma, Glenmark, Novartis, Pfizer, LEO Pharma, AbbVie, Eli Lilly, Kyowa Kirin, Mitsubishi Tanabe, Asana Biosciences, Union Therapeutics, Allergan, Amgen, Concert, DS Biopharma, EMD Serono, Escalier, and Flx Bio. Drs Peeva and Banerjee are employees and stockholders of Pfizer. Dr Sinclair has provided professional services for Novartis, Merck & Co, Janssen, Samson Clinical, Pfizer, Eli Lilly and Company, Arena, Demira, AstraZeneca, Sanofi, AbbVie, Galderma, Principia, Reistone Pharma, Aclaris, and Sun Pharma. Dr Zhu is an employee and stockholder of Pfizer. Dr Cox is a paid consultant to Pfizer. Dr Craiglow has participated on advisory boards, received honoraria and consulting fees from Aclaris, Arena Pharmaceuticals, and Pfizer, and participated on the speaker's bureau for Regeneron and Sanofi-Genzyme. Drs Chen and Zhang were employees of Pfizer at the time the study was conducted. Drs Banfield, Page, and Vincent are employees and stockholders of Pfizer. Dr Pavel has no conflicts of interest to declare.

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