Funding

This study was sponsored by Pfizer, Inc.

Conflict of Interest

Gil Yosipovitch is a consultant and advisor for Cara Therapeutics, Eli Lilly, Escient, Galderma, GlaxoSmithKline, Kiniksa, LEO Pharma, Novartis, Pfizer Inc., Regeneron, Sanofi, Trevi Therapeutics, and Vifor and a principal investigator for Arcutis, Celldex, Eli Lilly, Escient, Galderma, Kiniksa, LEO Pharma, Novartis, Pfizer Inc., and Sanofi Regeneron. Melinda J. Gooderham has received grants, personal fees, honoraria, and/or nonfinancial support from AbbVie, Amgen, AkrosPharma, AnaptysBio, Arcutis, ASLAN Pharmaceuticals, Bausch Health (Valeant), Bristol Myers Squibb, Boehringer-Ingelheim, Celgene, Dermavant Sciences, Dermira, Eli Lilly, Galderma, Janssen, Kyowa Kirin, LEO Pharma, MedImmune, Meiji, Merck, Novartis, Pfizer Inc., Roche, Sanofi Genzyme, Regeneron, Sun Pharma, and UCB. Sonja Ständer is a principal investigator for Almirall, Dermasence, Galderma, Kiniksa, LEO Pharma, Menlo Therapeutics, Novartis, Sanofi, and Trevi Therapeutics; a member of scientific advisory boards for Beiersdorf, Celgene, Galderma, Kiniksa, Pfizer, and Trevi Therapeutics; and a consultant for Bellus Health, Galderma, Novartis, Sanofi, and Vifor. Luz Fonacier received research grants (made to NYU Langone Hospital-LI) from AstraZeneca, Pfizer, Regeneron, and Shire and was a consultant and advisor for AbbVie, Eli Lilly, Pfizer, and Regeneron. Jacek C. Szepietowski has been a consultant/advisory board member for LEO Pharma, Novartis, Sanofi Genzyme, Trevi, and Viofor; a speaker for AbbVie, LEO Pharma, Novartis, Sanofi Genzyme, and Sunfarm; and an investigator for AbbVie, Bristol Myers Squibb, Galapagos, Galderma, Helm, Incyte, InfaRX, Janssen-Cilag, Novartis, Pfizer, Regeneron, UCB, and Trevi. Mette Deleuran has been a principal investigator in clinical trials and an advisory board member and/or speaker for AbbVie, ASLAN, Arena Pharmaceuticals, Eli Lilly, Incyte, La Roche Posay, LEO Pharma, Novartis, Pfizer, Pierre Fabre, Regeneron, and Sanofi Genzyme. Giampiero Girolomoni has been principal investigator in clinical trials sponsored by and/or has received personal fees from AbbVie, Almirall, Amgen, Biogen, Boehringer-Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Fresenius Kabi, Genzyme, LEO Pharma, Menlo Therapeutics, Novartis, OM Pharma, Pfizer, Regeneron, Samsung Bioepis, and Sanofi. John Su has received grants/research funding for his role as an investigator for AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Galderma, Janssen, Novartis, Pfizer Inc., Pierre Fabre, and Sanofi; has received honoraria for serving on advisory boards for Eli Lilly, GSK, Janssen, LEO Pharma, L’Oréal, Novartis, Pfizer Inc., and Sanofi; and has received honoraria for serving as a speaker for Ego Pharmaceuticals and Pierre Fabre. Andrew G. Bushmakin, Pinaki Biswas, Claire Feeney, Hernan Valdez, Andrew J. Thorpe, Gary Chan, Joseph C. Cappelleri, Marco DiBonaventura, and Daniela E. Myers are employees and shareholders of Pfizer Inc. Ricardo Rojo is a former employee and current shareholder of Pfizer Inc.

Ethics Approval

All study documents and procedures were approved by the appropriate institutional review boards/ethics committees at each study site. The study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization Good Clinical Practice Guidelines. All local regulatory requirements were followed. This research was approved by institutional review boards or ethics committees at each study site. An internal review committee monitored the safety of patients throughout the study.

Consent to Participate

All patients provided written informed consent.

Consent to Publish

Not applicable.

Availability of Data and Materials

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.

Code Availability

Not applicable.

Author Contributions

Andrew G. Bushmakin, Joseph C. Cappelleri, and Daniela E. Myers contributed to study concept and design. Andrew G. Bushmakin and Joseph C. Cappelleri conducted the statistical analysis of the data. Gil Yosipovitch, Melinda J. Gooderham, Sonja Ständer, Luz Fonacier, Jacek C. Szepietowski, Mette Deleuran, Giampiero Girolomoni, John C. Su, Andrew G. Bushmakin, Joseph C. Cappelleri, Claire Feeney, Gary Chan, Andrew J. Thorpe, Hernan Valdez, Pinaki Biswas, Ricardo Rojo, Marco DiBonaventura, and Daniela E. Myers interpreted the data, provided critical feedback on the manuscript, approved the final manuscript for submission, and are accountable for the accuracy and integrity of the manuscript.