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. |
|
| Funding sources: This study was sponsored by Pfizer, Inc. |
|
| 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 numéro
Article précédent
- Spinosad at 0.9% in the treatment of scabies: Efficacy results from 2 multicenter, randomized, double-blind, vehicle-controlled studies
- Jeffrey C. Seiler, Richard C. Keech, Julie L. Aker, William Miller, Christopher Belcher, Kerry W. Mettert
- Clinical and pathologic correlation of cutaneous COVID-19 vaccine reactions including V-REPP: A registry-based study
- Devon E. McMahon, Carrie L. Kovarik, William Damsky, Misha Rosenbach, Jules B. Lipoff, Anisha Tyagi, Grace Chamberlin, Ramie Fathy, Rosalynn M. Nazarian, Seemal R. Desai, Henry W. Lim, Bruce H. Thiers, George J. Hruza, Lars E. French, Kimberly Blumenthal, Lindy P. Fox, Esther E. Freeman
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?