Simpson, Eric L.
Silverberg, Jonathan I.
Nosbaum, Audrey
Winthrop, Kevin
Guttman-Yassky, Emma
Hoffmeister, Karin M.
Egeberg, Alexander
Valdez, Hernan
Fan, Haiyun
Farooqui, Saleem A.
Chan, Gary
Alderfer, Justine http://orcid.org/0000-0003-3006-1675
Romero, William
Chittuluru, Kanti
Funding for this research was provided by:
Pfizer
Article History
Accepted: 1 May 2024
First Online: 18 June 2024
Declarations
:
: This study was funded by Pfizer, Inc. The open access fee was funded by Pfizer Inc.
: Eric L. Simpson has received grants from Pfizer Inc., Eli Lilly and Company, Kyowa Kirin, LEO Pharma, Merck, and Regeneron Pharmaceuticals, and personal fees from Pfizer Inc., Bausch Health (Valeant), Dermira, Eli Lilly and Company, Galderma, LEO Pharma, Menlo Therapeutics, Novartis, Regeneron Pharmaceuticals, and Sanofi Genzyme. 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. Audrey Nosbaum is a consultant for Pfizer Inc., AbbVie, Eli Lilly and Company, Galderma, LEO Pharma, Novartis, and Sanofi Genzyme; a speaker for AbbVie, Regeneron Pharmaceuticals, and Sanofi Genzyme; an investigator for AbbVie, Eli Lilly and Company, Incyte, LEO Pharma, Novartis, and Sanofi Genzyme; and is on advisory boards for Pfizer Inc., AbbVie, LEO Pharma, and Sanofi Genzyme. Kevin Winthrop reports research grants from Pfizer Inc. and Bristol Myers Squibb, and consulting fees from Pfizer Inc., AbbVie, AstraZeneca, Bristol Myers Squibb, Eli Lilly and Company, Galapagos, Gilead, GlaxoSmithKline, Novartis, Regeneron Pharmaceuticals, Roche, and Union Chimique Belge (UCB). Emma Guttman-Yassky has served as an advisory board member for Pfizer Inc., Asana BioSciences (honorarium), Celgene, Dermira, Galderma, Glenmark, MedImmune, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Stiefel/GlaxoSmithKline, and Vitae; a consultant for Pfizer Inc., AbbVie, Almirall (honorarium), Anacor, Asana BioSciences, Celgene, Dermira, Eli Lilly and Company, Galderma, Glenmark, Kiowa Kirin, LEO Pharma, MedImmune, Mitsubishi Tanabe, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Stiefel/GlaxoSmithKline, and Vitae; and an investigator for Celgene, Eli Lilly and Company (grants to institution), LEO Pharma, MedImmune, and Regeneron Pharmaceuticals. Karin M. Hoffmeister has no disclosures to report. Alexander Egeberg has received research funding from Pfizer Inc., AbbVie, Almirall, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly and Company, Novartis, Janssen, the Danish National Psoriasis Foundation, the Simon Spies Foundation, and the Kongelig Hofbuntmager Aage Bangs Foundation; and honoraria as consultant and/or speaker from Pfizer Inc., AbbVie, Amgen, Almirall, Bristol Myers Squibb, Boehringer Ingelheim, Dermavant, Eli Lilly and Company, Galápagos NV, Galderma, Horizon Therapeutics, Janssen, LEO Pharma, McNeil Consumer Healthcare, Mylan, Novartis, Samsung Bioepis Co., Ltd., Sun Pharmaceutical, UCB, UNION Therapeutics, and Zuellig Pharma Ltd. He is a current employee of LEO Pharma. Hernan Valdez, Haiyun Fan, Saleem A. Farooqui, Gary Chan, Justine Alderfer, William Romero, and Kanti Chittuluru are employees and shareholders of Pfizer Inc.
: All study documents and procedures were approved by the appropriate institutional review boards/ethics committees at each study site. The studies were conducted in compliance with the ethical principles from the Declaration of Helsinki and all International Council for Harmonisation Good Clinical Practice Guidelines. All local regulatory requirements were followed.
: Informed consent was obtained from all participants of the individual studies included in this updated integrated safety analysis.
: Not applicable.
: 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 for more information.
: Not applicable.
: ELS, JIS, AN, KW, EGY, KMH, AE, HV, SAF, GC, JA, WR, and KC contributed to the conceptualization and design of the analysis. HF performed or supported the data analysis. All authors 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 article.