TY - JOUR
T1 - Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis
T2 - Results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN phase 3 trial
AU - Blauvelt, Andrew
AU - Silverberg, Jonathan I.
AU - Lynde, Charles W.
AU - Bieber, Thomas
AU - Eisman, Samantha
AU - Zdybski, Jacek
AU - Gubelin, Walter
AU - Simpson, Eric L.
AU - Valenzuela, Fernando
AU - Criado, Paulo Ricardo
AU - Lebwohl, Mark G.
AU - Feeney, Claire
AU - Khan, Tahira
AU - Biswas, Pinaki
AU - DiBonaventura, Marco
AU - Valdez, Hernan
AU - Cameron, Michael C.
AU - Rojo, Ricardo
N1 - Publisher Copyright:
© 2021 American Academy of Dermatology, Inc.
PY - 2022/1
Y1 - 2022/1
N2 - 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.
AB - 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.
KW - JADE REGIMEN
KW - JAK1 inhibitor
KW - abrocitinib
KW - atopic dermatitis
KW - response
KW - treatment
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U2 - 10.1016/j.jaad.2021.05.075
DO - 10.1016/j.jaad.2021.05.075
M3 - Article
C2 - 34416294
AN - SCOPUS:85114510514
SN - 0190-9622
VL - 86
SP - 104
EP - 112
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
IS - 1
ER -