We thank the participants of the study.
This study was sponsored by Corrona, LLC and the analysis was funded by Celgene Corporation. Amgen acquired the worldwide rights to Otezla® (apremilast) on November 21, 2019. Amgen funded the journal’s rapid service fee.
Medical Writing and/or Editorial Assistance
The authors received editorial support in the preparation of this report from Amy Shaberman, PhD, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, USA, sponsored by Celgene Corporation, Summit, NJ, USA and Amgen Inc., Thousand Oaks, CA, USA. The authors, however, directed and are fully responsible for all content and editorial decisions for this report.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship of this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
All authors contributed to the interpretation of the results.
Dr. Gottlieb has received honoraria as an advisory board member and consultant for Avotres Therapeutics, Beiersdorf, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Incyte, Janssen, LEO Pharma, Novartis, Sun Pharmaceutical Industries, UCB, and Xbiotech (only stock options which she has not used), and has received research/educational grants from Boehringer Ingelheim, Incyte, Janssen, Novartis, Sun Pharmaceuticals, UCB, and Xbiotech. Dr. Merola is a consultant and/or investigator for AbbVie, Arena, Avotres, Biogen, Bristol-Myers Squibb, Celgene Corporation, Dermavant, Eli Lilly and Company, EMD Serono, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB. Dr. Cirulli was an employee of Celgene Corporation at the time of the analysis and is currently an employee of Cara Therapeutics, Inc. Ms. Williams, Mr. Linowski, and Dr. Paris are employees of Amgen Inc. Dr. Litman, Ms. Guo, Ms. Emeanuru, Dr. McLean, and Ms. Cronin are employees of Corrona. Dr. Strober has served as a consultant and advisory board member for AbbVie, Almirall, Amgen Inc., Arena, Aristea, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene Corporation, Dermavant, Dermira, Eli Lilly and Company, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, Leo Pharma, Meiji Seika Pharma, Novartis, Ortho Dermatologics, Pfizer Inc., Regeneron, Sanofi-Genzyme, Sun Pharma, and UCB; has served as an investigator for AbbVie, Corrona Psoriasis Registry, Dermavant, and Dermira; has served as a speaker for AbbVie, Amgen Inc., Eli Lilly and Company, Janssen, and Ortho Dermatologics; and is the Scientific Co-Director for the Corrona Psoriasis Registry.
Corrona has been supported through contracted subscriptions in the last 2 years by AbbVie, Amgen Inc., Boehringer Ingelheim, Bristol-Myers Squibb, Celgene Corporation, Eli Lilly and Company, Genentech, Gilead, Janssen, Merck, Novartis, Ortho Dermatologics, Pfizer Inc., Regeneron, Sanofi-Genzyme, and Sun Pharma.
Compliance with Ethics Guidelines
All participating investigators were required to obtain full board approval to conduct research involving human subjects. Sponsor approval and continuing review approval was obtained through a central institutional review board (IRB; IntegReview, Corrona-PSO-500). For academic investigative sites that did not receive a waiver to use the central IRB, full board approval was obtained from the respective governing IRBs, and approval documentation was submitted to the sponsor before initiating any study procedures. This study was performed in accordance with the Helsinki Declaration of 1964 and its later amendments. All registry patients were required to provide written informed consent before participating in the registry.
The Corrona dataset is based on a large US multicenter study adhering to a number of institutional review boards, with complex logistics. Patients did not provide their consent for raw data sharing during the data collection for this purpose, and the Corrona data sharing policies do not permit raw data sharing for this purpose. An aggregated limited dataset from the current analyses is available to qualified investigators with an approved protocol. Data requests may be sent to Corrona, represented by Dr. Jeffrey D. Greenberg MD MPH, NYU School of Medicine, New York, NY, e-mail firstname.lastname@example.org.