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Abstract
Background
Differences in atopic dermatitis (AD) disease course and manifestation with age may extend to treatment response.
Objective
To evaluate response maintenance with continuous-/reduced-dose abrocitinib or withdrawal and response to treatment reintroduction after flare in adolescent and adult participants in JADE REGIMEN (NCT03627767).
Methods
Adolescents (12–17 years) and adults with moderate-to-severe AD responding to abrocitinib 200-mg induction were randomly assigned to 40-week maintenance with abrocitinib (200 mg/100 mg) or placebo. Patients who experienced flare during maintenance received rescue treatment.
Results
Of 246 adolescents and 981 adults, 145/246 (58.9%) and 655/981 (66.8%), respectively, responded to induction. Similar proportions of adolescents and adults experienced flare during maintenance with abrocitinib 200 mg (14.9%/16.9%), 100 mg (42.9%/38.9%), and placebo (75.5%/78.0%). From the abrocitinib 200-mg, 100-mg, and placebo arms, respectively, Eczema Area and Severity Index response was recaptured by 28.6%, 25.0%, and 52.9% of adolescents and 34.3%, 33.7%, and 58.0% of adults; Investigator’s Global Assessment response, by 42.9%, 50.0%, and 73.5% of adolescents and 34.3%, 50.6%, and 74.1% of adults. Abrocitinib had a similar safety profile regardless of age; nausea incidence was higher in adolescents.
Limitations
Adolescents represented 20% of the trial population.
Conclusion
Abrocitinib was effective in preventing flare in adolescents and adults.Clinicaltrials.gov listing: NCT03627767.
Acknowledgments
Editorial/medical writing support under the guidance of the authors was provided by Megan K. Elder, PhD, at ApotheCom, San Francisco, CA, USA, and was funded by Pfizer Inc., New York, NY, USA, in accordance with Good Publication Practice (GPP 2022) guidelines (Ann Intern Med. 2022;10.7326/M22-1460).
Disclosure statement
C Flohr is an investigator with funding from the European Union Horizon 2020 Program, the UK-Irish Atopic Eczema Systemic Therapy Register (A-STAR), and UK National Institute for Health and Care Research (NIHR), has provided unpaid advice to Pfizer Inc., AbbVie, Eli Lilly and Company, LEO Pharma, and Sanofi-Genzyme, and holds investigator-led funding from Pfizer Inc. and Sanofi-Genzyme. MJC is an investigator for Pfizer Inc., Atopix, Galapagos Pharmaceutical Company, Hyphens Pharma, Johnson & Johnson, Kymab, LEO Pharma, L’Oréal/La Roche-Posay, Novartis, Regeneron, and Sanofi-Genzyme and an advisory board member/consultant/speaker for Pfizer Inc., AbbVie, Amlar, Astellas, Atopix, Boots, Dermavant, Galapagos Pharmaceutical Company, Galderma, Hyphens Pharma, Johnson & Johnson, Kymab, LEO Pharma, L’Oréal/La Roche-Posay, Menlo Therapeutics, Novartis, Oxagen, Procter & Gamble, Reckitt Benckiser, Regeneron, and Sanofi-Genzyme. MRAJ is a speaker/consultant/advisor/research collaborator for Pfizer Inc., AbbVie, Amgen, Ducentis BioTherapeutics, Sosei Heptares, LEO Pharma, Sanofi-Genzyme, and Unilever. LFE is an adviser/consultant/clinical study investigator for Pfizer Inc., AbbVie, Almirall, Amgen, Arcutis, Arena Pharmaceuticals, Dermavant, Dermira, Eli Lilly, and Company, Forté, Galderma, Glenmark/Ichnos, Incyte, LEO Pharma, Novartis, Ortho Dermatologics, Regeneron, and Sanofi-Genzyme. SB has served as a scientific adviser/consultant/clinical study investigator for Pfizer Inc., AbbVie, Almirall, Eli Lilly and Company, Janssen, Laboratoire La Roche Posay, LEO Pharma, Pierre Fabre Laboratory, Novartis, Sanofi-Genzyme, and UCB Pharma. C Feeney and JN are employees and stockholders of Pfizer Inc. RR is a former employee and a current stockholder of Pfizer Inc. IL is an employee of IQVIA Pharmaceuticals and was a paid contractor to Pfizer Inc. for manuscript development and statistical support.
Data availability statement
Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information.
Correction Statement
This article has been republished with minor changes. These changes do not impact the academic content of the article.