Funding

This study and the Journal’s Rapid Service fee were funded by Pfizer Inc.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Author Contributions

BG, LT, LM, JLW, and MGL contributed to the conceptualization and design of the study; BG, LM, and CZ performed the data analysis; and all authors contributed to data interpretation. All authors drafted and critically reviewed the manuscript and approved the final version.

Medical Writing Assistance

Medical writing support under the guidance of the authors was provided by Stephanie O. Agbu, PhD, Robert J. Schoen, PharmD, and Jennifer C. Jaworski, MS, at ApotheCom, San Francisco, CA, USA, and was funded by Pfizer Inc., New York, NY, USA, in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med. 2015;163:461–464).

Disclosures

Bob Geng has received honoraria as a consultant for Pfizer Inc., and as a speaker/consultant for Regeneron and Sanofi Genzyme. Adelaide A. Hebert is an employee of UTHealth McGovern Medical School, which receives research funds from Pfizer Inc., Anacor, Brikell, Cutanea, Dermira, GSK, and Novan; has received honoraria as a member of data safety monitoring boards for Bausch Health (Valeant), GSK, and Regeneron-Sanofi; and has received honoraria from Pfizer Inc., Biofrontera, Cutanea, Dermira, Galderma, Eli Lilly, Ortho Dermatologics, and Pierre Fabre. Liza Takiya, John L. Werth, and Chuanbo Zang are employees and stockholders of Pfizer Inc. Lauren Miller is a consultant for Pfizer Inc., AbbVie, Amgen, Castle Bioscience, Ortho Dermatologics, Novartis, Regeneron, and Sanofi Genzyme; and is a speaker for Pfizer Inc., Amgen, Eli Lilly, Novartis, Regeneron, and Sanofi Genzyme. Paul Sanders is an employee and stockholder of Pfizer R&D UK Ltd. Mark G. Lebwohl is an employee of Mount Sinai, which receives research funds from AbbVie, Amgen, Arcutis, Boehringer Ingelheim, Dermavant, Eli Lilly, Incyte, Janssen Research & Development, LEO Pharma, Ortho Dermatologics, Pfizer, and UCB; and is a consultant for Pfizer Inc., Aditum Bio, Allergan, Almirall, Arcutis, Avotres Therapeutics, BirchBioMed, BMD Skincare, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant, Evelo, Facilitate International Dermatologic Education, Foundation for Research and Education in Dermatology, Inozyme Pharma, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi, Neuroderm, Promius/Dr. Reddy’s Laboratories, Serono, Theravance, and Verrica.

Compliance with Ethics Guidelines

Quorum Review Institutional Review Board approved the protocol at each site. Written informed consent was obtained from patients or guardians. The study was conducted in accordance with the principles of Good Clinical Practice, the ethical principles originating in the Declaration of Helsinki, and all regional regulatory requirements.

Data Availability

The datasets generated during and/or analyzed during the current study are not publicly available. Upon request, and subject to certain criteria, conditions and exceptions (see https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines, and medical devices (1) for indications that have been approved in the USA and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.

Prior Presentation

This analysis was previously presented in part at the 2020 Virtual Annual Meeting of the American Academy of Allergy, Asthma, & Immunology, 13–16 March 2020; the 33rd Annual Eastern Allergy Conference, 16–18 August 2020, Palm Beach, FL, USA; Maui Derm Virtual Congress, 24–27 June 2020; and the Revolutionizing Atopic Dermatitis 2020 Virtual Symposium, 5 April 2020.