Dua, Anisha B. http://orcid.org/0000-0002-3508-9290
Ford, Kerri
Fiore, Stefano http://orcid.org/0000-0002-3785-2448
Pappas, Dimitrios A. http://orcid.org/0000-0001-8338-027X
Janak, Jud C.
Blachley, Taylor
Roberts-Toler, Carla
Emeanuru, Kelechi http://orcid.org/0000-0001-7097-188X
Kremer, Joel M. http://orcid.org/0000-0001-6674-9901
Kivitz, Alan http://orcid.org/0000-0002-1045-1310
Funding for this research was provided by:
Sanofi
Regeneron Pharmaceuticals
Article History
Received: 18 August 2023
Accepted: 6 October 2023
First Online: 31 October 2023
Declarations
:
: Anisha B Dua reports consulting/advisory board for AbbVie, Novartis and ChemoCentryx; and is a board member of Vasculitis foundation and Chicago Rheumatism Society (not paid). Kerri Ford and Stefano Fiore are employees of Sanofi and may hold stock and/or stock options in the company. Dimitrios A Pappas reports consulting for Sanofi, AbbVie; Gtech Roche Hellas, and Novartis; is an employee of CorEvitas LLC; has equity interest in CorEvitas, LLC; and is a member of the Board of Directors, Corrona Research Foundation. Taylor Blachley is an employee of CorEvitas, LLC and has no disclosures. Carla Roberts-Toler was an employee of CorEvitas, LLC at the time this study was conducted; currently, she is an employee of Harvard T. H. Chan School of Public Health and has no disclosures. Jud C Janak was an employee of CorEvitas, LLC at the time this study was conducted; and has no disclosures. Kelechi Emeanuru was an employee of CorEvitas, LLC at the time this study was conducted; currently, she is an employee of Evidera and has no disclosures. Joel M Kremer is a consultant for CorEvitas, LLC. Alan Kivitz has received study funding, medical writing support, and article processing charges from Amgen; has received consulting fees from Pfizer, Janssen, Boehringer Ingelheim, AbbVie, Flexion, Gilead, Grunenthal, Orion, Regeneron, Sun Pharma Advance Research, and ECOR1; has received payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing or educational events from Merck & Co, Eli Lilly, Novartis, Pfizer, Flexion, AbbVie, Amgen, Genentech, Regeneron, UCB, Horizon, and GSK; has participated in a data safety monitoring board for AbbVie and Amgen; has been part of a board or advisory board for AbbVie, Bendcare, Boehringer Ingelheim, ChemoCentryx, Flexion, Gilead, Grunenthal, Horizon, Eli Lilly, Janssen, Pfizer, Regeneron, UCB, and Novartis; and has stock or stock options in Pfizer, GSK, Gilead, Novartis, and Amgen.
: The study was conducted in accordance with the Declaration of Helsinki, and all participating investigators obtained full ethics or institutional review board (IRB) approval for conducting research in patients. The Sponsor approval and continuing review were obtained through a central IRB, New England Independent Review Board (NEIRB No. 120160610). For academic investigative sites that did not receive a waiver to use the central IRB, approval was obtained from the respective governing IRBs, and documentation of approval was submitted to the Sponsor prior to initiating any study procedures. All registry patients were required to provide written informed consent prior to participation.