Artículo de revista
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
Fecha
2022Registro en:
J Am Acad Dermatol (2022) 86
10.1016/j.jaad.2021.05.075
Autor
Blauvelt, Andrew
Silverberg, Jonathan I.
Lynde, Charles W.
Bieber, Thomas
Eisman, Samantha
Zdybski, Jacek
Gubelin, Walter
Simpson, Eric L.
Valenzuela Ahumada, Fernando Alfredo
Criado, Paulo Ricardo
Lebwohl, Mark G.
Feeney, Claire
Khan, Tahira
Biswas, Pinaki
DiBonaventura, Marco
Valdez, Hernán
Cameron, Michael C.
Rojo, Ricardo
Institución
Resumen
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.