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
Author
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Blauvelt, Andrew
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Silverberg, Jonathan I.
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Lynde, Charles W.
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Bieber, Thomas
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Eisman, Samantha
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Zdybski, Jacek
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Gubelin, Walter
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Simpson, Eric L.
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Valenzuela Ahumada, Fernando Alfredo
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Criado, Paulo Ricardo
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Lebwohl, Mark G.
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Feeney, Claire
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Khan, Tahira
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Biswas, Pinaki
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DiBonaventura, Marco
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Valdez, Hernán
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Cameron, Michael C.
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Rojo, Ricardo
Admission date
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2022-12-01T19:52:32Z
Available date
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2022-12-01T19:52:32Z
Publication date
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2022
Cita de ítem
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J Am Acad Dermatol (2022) 86
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Identifier
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10.1016/j.jaad.2021.05.075
Identifier
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https://repositorio.uchile.cl/handle/2250/189559
Abstract
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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.
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Patrocinador
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Pfizer
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Lenguage
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en
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Publisher
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Elsevier
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Type of license
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Attribution-NonCommercial-NoDerivs 3.0 United States
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