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, Jonathan I. Silverberg, Charles W. Lynde, Thomas Bieber, Samantha Eisman, Jacek Zdybski, Walter Gubelin, Eric L. Simpson, Fernando Valenzuela, Paulo Ricardo Criado, Mark G. Lebwohl, Claire Feeney, Tahira Khan, Pinaki Biswas, Marco DiBonaventura, Hernan Valdez, Michael C. Cameron, Ricardo Rojo

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)104-112
Number of pages9
JournalJournal of the American Academy of Dermatology
Volume86
Issue number1
DOIs
StatePublished - Jan 2022

Keywords

  • JADE REGIMEN
  • JAK1 inhibitor
  • abrocitinib
  • atopic dermatitis
  • response
  • treatment

ASJC Scopus subject areas

  • Dermatology

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