Funding

This study was sponsored by Pfizer Inc. Medical writing support was funded by Pfizer Inc. Pfizer Inc contributed to the conception/design of the study, data acquisition and analyses, and data interpretation. The journal’s Rapid Service Fee for this article was also funded by Pfizer Inc.

Medical Writing, Editorial, and Other Assistance

Medical writing support, under the guidance of the authors, was provided by Laura Graham, PhD, and Lauren Hogarth, MSc, CMC Connect, a division of IPG Health Medical Communications, funded by Pfizer Inc, New York, NY, USA, in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med. 2015;163:461–4).

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

KdeV, PJM, AGB, RF, AO, JFM, JW, JCC, LF, and PCT conceived or designed the study, and were involved in data analysis. KdeV, PJM, AGB, RF, JFM, and JCC acquired the data. All authors had access to the data, were involved in the interpretation of the data, reviewed and approved the manuscript’s content before submission, and agree to be accountable for all aspects of the work.

Prior Presentation

This manuscript is based on work that has been previously presented in a poster at EULAR 2020 (Taylor PC et al. Ann Rheum Dis. 2020;79:1724–5 [abstract AB0838]).

Disclosures

Kurt de Vlam has received grant/research support from Celgene, has been a consultant for Eli Lilly, Galapagos NV, Gilead Sciences, Janssen, Novartis, Pfizer Inc, and UCB, and has participated in speakers’ bureau for Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, and UCB. Philip J Mease has received grant/research support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, Sun Pharma, and UCB, has been a consultant for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, CorEvitas, Eli Lilly, Galapagos, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer Inc, Sun, Pharma and UCB, and has participated in speakers’ bureau for AbbVie, Amgen, Janssen, Novartis, Pfizer Inc, and UCB. Andrew G Bushmakin, John Woolcott, Joseph C Cappelleri, and Lara Fallon are employees and shareholders of Pfizer Inc. Roy Fleischmann has received grant/research support from, and has been a consultant for, AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celltrion, Eli Lilly, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Novartis, Noven, Pfizer Inc, Roche, Sanofi-Aventis, UCB, Viela, and VORSO. Alexis Ogdie has received grant/research support from AbbVie, Amgen, Novartis, and Pfizer Inc, and has been a consultant for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, CorEvitas, Eli Lilly, Gilead Sciences, Janssen, Novartis, Pfizer Inc, and UCB. Valderilio F Azevedo has received grant/research support from, and has been a consultant for, AbbVie, Amgen, Fresenius Kabi, GlaxoSmithKline, Janssen, Merck Serono, Novartis, Pfizer Inc, Sandoz, and UCB. Joseph F Merola has been a consultant and/or investigator for AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Dermavant, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer Inc, Regeneron, Sanofi, Sun Pharma, and UCB. Peter C Taylor has received grant/research support from Celgene and Galapagos, and has been a consultant for AbbVie, Bristol-Myers Squibb, Biogen, Celltrion, Eli Lilly, Fresenius, Galapagos NV, Gilead Sciences, GlaxoSmithKline, Janssen, Nordic Pharma, Pfizer Inc, Sanofi, and UCB

Compliance with Ethics Guidelines

Both studies were conducted in accordance with the International Conference on Harmonization Good Clinical Practice guidelines and the principles of the Declaration of Helsinki, and they were approved by the relevant institutional review board or independent ethics committee at each investigational site [28, 29]. All patients provided written informed consent. No further ethical approval was required for this post hoc analysis in accordance with the policies of our institutions.

Data Availability

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.