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

Blauvelt, Andrew; Silverberg, Jonathan, I; Lynde, Charles W.; Bieber, Thomas; Eisman, Samantha; Zdybski, Jacek; Gubelin, Walter; Simpson, Eric L.; Valenzuela, Fernando; Criado, Paulo Ricardo; Lebwohl, Mark G.; Feeney, Claire; Khan, Tahira; Biswas, Pinaki; DiBonaventura, Marco; et. al.

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."

Más información

Título según WOS: 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
Título de la Revista: JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Volumen: 86
Número: 1
Editorial: MOSBY-ELSEVIER
Fecha de publicación: 2022
Página de inicio: 104
Página final: 112
DOI:

10.1016/j.jaad.2021.05.075

Notas: ISI