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 - 09/12/21
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.
Le texte complet de cet article est disponible en PDF.Key words : abrocitinib, atopic dermatitis, JADE REGIMEN, JAK1 inhibitor, response, treatment
Abbreviations used : AD, AE, EASI, IGA, IL, IR, PP-NRS, TEAE
Plan
Dr Cameron is currently affiliated with Icahn School of Medicine at Mount Sinai Medical Center, New York, New York. |
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Funding sources: This study was sponsored by Pfizer, Inc. |
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IRB approval status: This research was approved by institutional review boards or ethics committees at each site. |
Vol 86 - N° 1
P. 104-112 - janvier 2022 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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