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Clinical Trial
. 2022 Jan;86(1):104-112.
doi: 10.1016/j.jaad.2021.05.075. Epub 2021 Aug 17.

Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: Results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN phase 3 trial

Andrew Blauvelt  1 , Jonathan I Silverberg  2 , Charles W Lynde  3 , Thomas Bieber  4 , Samantha Eisman  5 , Jacek Zdybski  6 , Walter Gubelin  7 , Eric L Simpson  8 , Fernando Valenzuela  9 , Paulo Ricardo Criado  10 , Mark G Lebwohl  11 , Claire Feeney  12 , Tahira Khan  13 , Pinaki Biswas  14 , Marco DiBonaventura  14 , Hernan Valdez  14 , Michael C Cameron  14 , Ricardo Rojo  15
Affiliations
Free article
Clinical Trial

Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: Results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN phase 3 trial

Andrew Blauvelt et al. J Am Acad Dermatol. 2022 Jan.
Free article

Abstract

Background: The heterogeneous course of moderate-to-severe atopic dermatitis necessitates treatment flexibility.

Objective: We evaluated the maintenance of abrocitinib-induced response with continuous abrocitinib treatment, dose reduction or withdrawal, and response to treatment reintroduction following flare (JAK1 Atopic Dermatitis Efficacy and Safety [JADE] REGIMEN: National Clinical Trial 03627767).

Methods: Patients with moderate-to-severe atopic dermatitis responding to open-label abrocitinib 200 mg monotherapy for 12 weeks were randomly assigned in a 1:1:1 ratio to blinded abrocitinib (200 or 100 mg) or placebo for 40 weeks. Patients experiencing flare received rescue treatment (abrocitinib 200 mg plus topical therapy).

Results: Of 1233 patients, 798 responders to induction (64.7%) were randomly assigned. The flare probability during maintenance was 18.9%, 42.6%, and 80.9% with abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively. Among patients with flare in the abrocitinib 200 mg, abrocitinib 100 mg, and placebo groups, 36.6%, 58.8%, and 81.6% regained investigator global assessment 0/1 response, respectively, and 55.0%, 74.5%, and 91.8% regained eczema area and severity index response, respectively, with rescue treatment. During maintenance, 63.2% and 54.0% of patients receiving abrocitinib 200 and 100 mg, respectively, experienced adverse events.

Limitations: The definition of protocol-defined flare was not established, limiting the generalizability of findings.

Conclusion: Induction treatment with abrocitinib was effective; most responders continuing abrocitinib did not flare. Rescue treatment with abrocitinib plus topical therapy effectively recaptured response.

Keywords: JADE REGIMEN; JAK1 inhibitor; abrocitinib; atopic dermatitis; response; treatment.

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Conflict of interest statement

Conflicts of interest Dr Blauvelt has served as a scientific adviser and/or clinical study investigator for Pfizer, AbbVie, Aligos, Almirall, Amgen, Arcutis, Arena, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Evommune, Forte, Galderma, Incyte, Janssen, Leo, Novartis, RAPT, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB Pharma. Dr Silverberg has served as an investigator for AbbVie, Eli Lilly, Galderma, Kiniksa, LEO Pharma, and Trevi; as a consultant or advisory board member for Pfizer Inc, AbbVie, AFYX, Arena, Asana, BiomX, Bluefin, Bodewell, Boehringer Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Kiniksa, Leo, Luna, Menlo, Novartis, RAPT, Regeneron, and Sanofi; and as a speaker for Pfizer, Regeneron, and Sanofi. Dr Lynde has served as a principal investigator, consultant, and/or speaker for Pfizer Inc, AbbVie, Bausch Health (Valeant), Celgene, Eli Lilly, Janssen, LEO Pharma, and Novartis. Dr Bieber is a lecturer and/or consultant for Pfizer Inc, AbbVie, Almirall, AnaptysBio, Arena Pharmaceuticals, Asana Biosciences, BioVersys, Boehringer Ingelheim, Daiichi Sankyo, Dermavant Roivant, Eli Lilly, Galapagos/MorphoSys, Galderma, Glenmark, GSK, Incyte, Kymab, Leo, La Roche-Posay, Menlo Therapeutics, Novartis, RAPT, Sanofi Regeneron, UCB, and Vectans Pharma and an investigator for AFYX (DermTreat). Dr Eisman has been an investigator in clinical trials for Pfizer Inc, AbbVie, Arena, Boston Pharmaceuticals, Bristol Myers Squibb, Botanix, Dermira, Eli Lilly, Leo, Novartis, Regeneron, and Suzhou Connect Biopharmaceuticals. Dr Zdybski has been an investigator for clinical trials for Pfizer, Trevi Pharmaceuticals, and Regeneron. Dr Gubelin has served as a scientific adviser and/or clinical study investigator for Pfizer, Galderma, GSK, Eucerin, Johnson & Johnson, Janssen, Sanofi, BioNOOX, and Beiersdorf/Eucerin. Dr Simpson reports grants from Pfizer Inc, Eli Lilly, Kyowa Kirin, Leo, Merck, and Regeneron and personal fees from Pfizer Inc, Bausch Health (Valeant), Dermira, Eli Lilly, Galderma, Leo, Menlo Therapeutics, Novartis, Regeneron, and Sanofi Genzyme. Dr Valenzuela has served as a scientific adviser and/or clinical study investigator for Pfizer, AbbVie, Amgen, Eli Lilly, Galderma, Janssen, Leo, Merck, Novartis, and Sanofi Genzyme. Dr Criado reports grants from Abbott, Takeda, Novartis, and Pfizer. Dr Lebwohl is an employee of Mount Sinai, which receives research funds from AbbVie, Amgen, Arcutis, Boehringer Ingelheim, Dermavant, Eli Lilly, Incyte, Janssen Research & Development, Leo, Ortho Dermatologics, Pfizer, and UCB and is a consultant for Aditum Bio, Allergan, Almirall, Arcutis, Avotres Therapeutics, BirchBioMed, BMD Skincare, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Evelo, Facilitate International Dermatologic Education, Foundation for Research and Education in Dermatology, Inozyme Pharma, Leo, Meiji Seika Pharma, Menlo, Mitsubishi Tanabe Pharma, Neuroderm, Pfizer, Promius/Dr. Reddy's Laboratories, Serono, Theravance, and Verrica. Drs Feeney, Khan, Biswas, DiBonaventura, Valdez, and Rojo are employees and shareholders of Pfizer Inc. Dr Cameron is a former employee and current shareholder of Pfizer Inc.

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