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

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dc.coverageDOI: 10.1016/j.jaad.2021.05.075
dc.creatorBlauvelt, Andrew
dc.creatorSilverberg, Jonathan I.
dc.creatorLynde, Charles W.
dc.creatorBieber, Thomas
dc.creatorEisman, Samantha
dc.creatorZdybski, Jacek
dc.creatorGubelin, Walter
dc.creatorSimpson, Eric L.
dc.creatorValenzuela, Fernando
dc.creatorCriado, Paulo Ricardo
dc.creatorLebwohl, Mark G.
dc.creatorFeeney, Claire
dc.creatorKhan, Tahira
dc.creatorBiswas, Pinaki
dc.creatorDiBonaventura, Marco
dc.creatorValdez, Hernan
dc.creatorCameron, Michael C.
dc.creatorRojo, Ricardo
dc.date2022
dc.date.accessioned2025-11-18T19:45:40Z
dc.date.available2025-11-18T19:45:40Z
dc.description<p>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.</p>eng
dc.identifierhttps://investigadores.uandes.cl/en/publications/a42c2f4c-1ca4-42fd-8ac0-9173d900de4f
dc.identifier.urihttps://repositorio.uandes.cl/handle/uandes/54104
dc.languageeng
dc.rightsinfo:eu-repo/semantics/openAccess
dc.sourcevol.86 (2022) nr.1 p.104-112
dc.subjectabrocitinib
dc.subjectatopic dermatitis
dc.subjectJADE REGIMEN
dc.subjectJAK1 inhibitor
dc.subjectresponse
dc.subjecttreatment
dc.titleAbrocitinib 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 trialeng
dc.typeArticleeng
dc.typeArtículospa
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