Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND)
- PMID: 35439608
- DOI: 10.1016/j.jaad.2022.04.009
Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND)
Abstract
Background: Abrocitinib efficacy by prior dupilumab response status in patients with moderate-to-severe atopic dermatitis has not previously been assessed in phase 3 studies.
Objective: Examine efficacy and safety of abrocitinib among patients who received prior dupilumab.
Methods: Patients with moderate-to-severe atopic dermatitis received abrocitinib 200 mg or 100 mg once daily in JADE EXTEND (phase 3 extension) after dupilumab in double-blind, placebo-controlled phase 3 JADE COMPARE.
Results: Among prior dupilumab responders, ≥75% improvement in Eczema Area and Severity Index was achieved in 93.5% and 90.2% of patients who received 12 weeks of abrocitinib 200 mg and 100 mg, respectively; ≥4-point improvement in Peak Pruritus Numerical Rating Scale was achieved in 89.7% and 81.6%, respectively. Among prior dupilumab nonresponders, ≥75% improvement in Eczema Area and Severity Index was achieved with abrocitinib 200 mg and 100 mg in 80.0% and 67.7% and ≥4-point improvement in Peak Pruritus Numerical Rating Scale in 77.3% and 37.8%, respectively. Most common adverse events among abrocitinib-treated patients were nasopharyngitis, nausea, acne, and headache. Conjunctivitis occurred less frequently with abrocitinib in comparison to prior dupilumab.
Limitations: Short-term, 12-week analysis; no placebo arm.
Conclusion: Efficacy and safety profile of abrocitinib in JADE EXTEND supports the role of abrocitinib as a treatment for patients with moderate-to-severe atopic dermatitis, regardless of prior dupilumab response status.
Keywords: abrocitinib; atopic dermatitis; dupilumab; efficacy; response; safety.
Copyright © 2022 American Academy of Dermatology, Inc. All rights reserved.
Conflict of interest statement
Conflicts of interest Dr Shi is a stockholder of Learn Health and has served as an advisory board member or investigator and/or received research funding from Pfizer Inc, Sanofi-Genzyme, Regeneron, AbbVie, Eli Lilly, Novartis, SUN Pharma, LEO Pharma, Menlo Therapeutics, Dermira, Burt’s Bees, Galderma, Kiniksa Pharmaceuticals, UCB, Altus Lab, MYOR, Polyfin, GpSkin, and Skin Actives Scientific. Dr Bhutani is an investigator for Pfizer Inc, AbbVie, Galderma, Mindera, and Regeneron. She has served as a consultant and/or advisory board member for Pfizer Inc, AbbVie, Arcutis, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, LEO Pharma, Eli Lilly, Novartis, Sun, and UCB. Dr Fonacier has been a consultant and advisory board member for Pfizer Inc, Regeneron, AbbVie, and Eli Lilly and has received research and educational grants (made to NYU Langone Hospital–Long Island) from Pfizer Inc, Regeneron, AstraZeneca, and Shire. Dr Deleuran has been a consultant, advisory board member, and/or speaker for Pfizer Inc, AbbVie, Eli Lilly, LEO Pharma, Regeneron, Incyte Biosciences International Sàrl, Sanofi-Genzyme, and Pierre Fabre. Dr Shumack has been an investigator, advisory board member, and/or speaker for Pfizer Inc, AbbVie, Eli Lilly, LEO Pharma, Sanofi, and Novartis. Drs Cameron and Yin are former employees of Pfizer Inc and may hold stock options. Drs Zhang, Chan, and Valdez are employees and shareholders of Pfizer Inc.
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