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. 2025 Feb;15(2):367-380.
doi: 10.1007/s13555-024-01320-y. Epub 2025 Feb 4.

Switching from Dupilumab to Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of Efficacy After Treatment With Dupilumab in JADE DARE

Jonathan I Silverberg  1 , Eric L Simpson  2 , Andrew E Pink  3   4 , Stephan Weidinger  5 , Gary Chan  6 , Pinaki Biswas  7 , Claire Clibborn  8 , Erman Güler  9
Affiliations

Switching from Dupilumab to Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of Efficacy After Treatment With Dupilumab in JADE DARE

Jonathan I Silverberg et al. Dermatol Ther (Heidelb). 2025 Feb.

Abstract

Introduction: Primary results of the JADE DARE trial (NCT04345367) demonstrated that abrocitinib was superior to dupilumab in reducing the signs and symptoms of moderate-to-severe atopic dermatitis (AD). This post hoc analysis evaluated the efficacy and safety of abrocitinib in patients with moderate-to-severe AD who were responders or nonresponders to dupilumab using various definitions of response.

Methods: Data included dupilumab-treated patients from JADE DARE who switched to abrocitinib 200 mg when enrolled in the ongoing JADE EXTEND trial (NCT03422822). For this analysis, various response criteria at Week 26 of JADE DARE were defined post hoc based on Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI), Peak Pruritus Numerical Rating Scale (PP-NRS), and Dermatology Life Quality Index (DLQI) scores or responses. Efficacy was analyzed at Week 12 of JADE EXTEND based on patients' fulfillment of the various response criteria at Week 26 of JADE DARE. EASI scores and percentage changes from baseline in EASI and PP-NRS at Week 26 in JADE DARE were compared with the corresponding scores and percentage changes at Week 12 in EXTEND. Safety was assessed.

Results: Of 365 dupilumab-treated patients in JADE DARE, 316 were enrolled in JADE EXTEND and 312 received abrocitinib 200 mg. Most dupilumab responders for IGA, EASI, PP-NRS, and DLQI at DARE Week 26 maintained their responses 12 weeks after switching to abrocitinib, while a considerable proportion of IGA, EASI, PP-NRS, or DLQI dupilumab nonresponders gained response after switching to abrocitinib. Lower EASI scores and greater percentage changes from baseline in EASI and PP-NRS scores were observed with abrocitinib at EXTEND Week 12 than with dupilumab at DARE Week 26. No new safety signals were observed.

Conclusion: Abrocitinib 200 mg may be an effective treatment option for patients with moderate-to-severe AD who do not achieve an optimal response with dupilumab treatment.

Clinical trial registration: Clinicaltrials.gov: NCT04345367 (JADE DARE) and NCT03422822 (JADE EXTEND).

Keywords: Abrocitinib; Atopic dermatitis; Dupilumab; JAK-1 selective inhibitor; Nonresponders; Responders; Switch.

Plain language summary

People with atopic dermatitis (AD) have cracked, dry, itchy, red, and painful skin patches. Those with stronger symptoms that do not respond well to creams or ointments applied directly to the damaged skin are said to have moderate or severe AD. Such patients need to take systemic therapy, either as injections or by mouth. Dupilumab, an injectable medicine, was the first systemic therapy approved for moderate or severe AD. Abrocitinib is another approved systemic therapy for moderate or severe AD that works in a different way and is taken by mouth. Currently, we do not know much about patients who had a weak response to dupilumab and switched to abrocitinib. In the JADE DARE clinical trial, participants could take either abrocitinib or dupilumab. After 26 weeks, they could enroll in another study, JADE EXTEND, where they could only take abrocitinib as systemic treatment. Here, we evaluated people who took dupilumab in JADE DARE and switched to abrocitinib in JADE EXTEND to see how well abrocitinib worked in patients who did not respond well to dupilumab treatment. We found that many patients who did not respond well to dupilumab responded strongly to abrocitinib. Most patients who responded well to dupilumab still retained their good response after switching to abrocitinib treatment. Together, these results show that abrocitinib can be a suitable alternative for people with moderate-to-severe AD who do not respond well to dupilumab. Switching From Dupilumab to Abrocitinib in Patients With Moderate-to-100 Severe Atopic Dermatitis: A Post Hoc Analysis of Efficacy After Treatment With 101 Dupilumab in JADE DARE (MP4 28274 kb).

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Conflict of interest statement

Declarations. Conflict of Interest: Jonathan I. Silverberg served as an investigator for Celgene, Eli Lilly and Company, F. Hoffmann-La Roche, Menlo Therapeutics, Realm Therapeutics, Regeneron Pharmaceuticals, and Sanofi Genzyme; as a consultant for Pfizer Inc., AbbVie, Anacor, AnaptysBio, Arena Pharmaceuticals, Dermavant, Dermira, Eli Lilly and Company, Galderma, GlaxoSmithKline, Glenmark, Incyte, Kiniksa Pharmaceuticals, LEO Pharma, Menlo Therapeutics, Novartis, Realm Therapeutics, Regeneron Pharmaceuticals, and Sanofi Genzyme; and as a speaker for Regeneron Pharmaceuticals and Sanofi Genzyme. Eric L. Simpson received grants from Pfizer Inc., Eli Lilly and Company, Kyowa Kirin, LEO Pharma, Merck, and Regeneron and personal fees from Pfizer Inc., Bausch Health (Valeant), Dermira, Eli Lilly and Company, Galderma, LEO Pharma, Menlo Therapeutics, Novartis, Regeneron, and Sanofi Genzyme. Andrew E. Pink has acted as an advisor or speaker for Pfizer Inc., AbbVie, Almirall, Elli Lilly and Company, Sanofi Genzyme, LEO Pharma, Janssen, Novartis, La Roche-Posay, and UCB. Stephan Weidinger has received institutional research grants from La Roche-Posay, LEO Pharma, and Sanofi Deutschland GmbH; has performed consultancies for Pfizer Inc., AbbVie, Eli Lilly and Company, Kymab, LEO Pharma, Novartis, Regeneron Pharmaceuticals, and Sanofi Genzyme; and has lectured at educational events sponsored by AbbVie, Galderma, LEO Pharma, Novartis, Regeneron Pharmaceuticals, and Sanofi Genzyme. Gary Chan, Pinaki Biswas, and Erman Güler are employees and shareholders of Pfizer Inc. Claire Clibborn is a former employee and current shareholder of Pfizer Ltd., and a current employee and shareholder of Ascendis Pharma. Ethical Approval: Study documents and procedures were approved by the appropriate institutional review boards/ethics committees at each study site. These trials were conducted in accordance with the ethical principles from the Declaration of Helsinki, International Ethical Guidelines for Biomedical Research Involving Human Subjects from the Council for International Organizations of Medical Sciences, and International Council for Harmonisation Good Clinical Practice Guidelines. Informed consent was obtained from all individual participants included in both trials.

Figures

Fig. 1
Fig. 1
Efficacy responses after 12-week switch to abrocitinib in dupilumab responders and nonresponders at Week 26 of JADE DARE. aIGA response defined as IGA score of 0 (clear) or 1 (almost clear) and ≥ 2-point improvement from baseline. DLQI Dermatology Life Quality Index, DLQI 0/1 DLQI score of 0 or 1, EASI Eczema Area and Severity Index, EASI-50 ≥ 50% improvement from baseline in EASI, EASI-75 ≥ 75% improvement from baseline in EASI, EASI-90 ≥ 90% improvement from baseline in EASI, IGA Investigator’s Global Assessment, PP-NRS Peak Pruritus Numerical Rating Scale, PP-NRS4 ≥ 4-point improvement from baseline in PP-NRS, PP-NRS 0/1 PP-NRS score of 0 or 1
Fig. 2
Fig. 2
Proportions of dupilumab-treated patients with a IGA = 3 and b IGA = 4 at Week 26 of JADE DARE in each IGA category by JADE EXTEND visit after switch to abrocitinib. aAt the time of the switch. IGA Investigator’s Global Assessment
Fig. 3
Fig. 3
Proportions of dupilumab-treated patients who were a EASI-50 responders, b EASI-50 nonresponders, c EASI-75 responders, d EASI-75 nonresponders, e EASI-90 responders, and f EASI-90 nonresponders at Week 26 of JADE DARE and gained incremental responses at Week 12 after switching to abrocitinib. aJADE DARE Week 26. bJADE EXTEND Week 12. EASI Eczema Area and Severity Index, EASI-50 ≥ 50% improvement from baseline in EASI, EASI < 50 < 50% improvement from baseline in EASI, EASI-75 ≥ 75% improvement from baseline in EASI, EASI < 75 < 75% improvement from baseline in EASI, EASI-90 ≥ 90% improvement from baseline in EASI, EASI < 90 < 90% improvement from baseline in EASI, EASI-100 100% improvement from baseline in EASI, EASI < 100 < 100% improvement from baseline in EASI
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