Emery, Paul
Tanaka, Yoshiya
Bykerk, Vivian P.
Bingham, Clifton O.
Huizinga, Thomas W. J.
Citera, Gustavo
Huang, Kuan-Hsiang Gary
Wu, Chun
Connolly, Sean E.
Elbez, Yedid
Wong, Robert
Lozenski, Karissa
Fleischmann, Roy
Article History
Received: 2 September 2022
Accepted: 27 March 2023
First Online: 22 April 2023
Declarations
:
: The study was conducted in accordance with the Declaration of Helsinki and International Conference on Harmonisation Good Clinical Practice. The protocol and patients’ informed consent received institutional review board/independent ethics committee approval prior to initiation of the study, and all patients provided informed consent prior to enrollment. The AVERT-2 study was governed by both a central institutional review board (IRB; the New England IRB) as well as local and university-based IRBs if required at individual sites. Approval numbers per site were not provided and are not available.
: Not applicable.
: PE has received grant/research support from Bristol Myers Squibb, Lilly, Novartis and Samsung; has received consulting fees from Boehringer Ingelheim, Bristol Myers Squibb, Lilly and Novartis; has received honoraria from Bristol Myers Squibb, Celltrion, GlaxoSmithKline, Lilly, Novartis and Samsung; and received support for meetings/travel from Novartis. YT has received grant/research support from AbbVie, Asahi-Kasei, Boehringer Ingelheim, Chugai, Corrona, Daiichi-Sankyo, Eisai and Takeda; and has received honoraria from AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, GlaxoSmithKline, Mitsubishi-Tanabe and Pfizer. VPB has received grant/research support from NIH/fNIH (Accelerated Medicines Program; funds to institution; grants 1UH2AR067691-01 and GRANT11652401) and Cedar Hill; has received consulting fees from Amgen, Bristol Myers Squibb, Genzyme, Gilead, Janssen, Sanofi and UCB; has participated on a Data Safety Monitoring Board for KAI; and acted as Project Advisor for Pfizer. Additionally, VPB’s spouse is an employee of and has ownership interest in Brainstorm Therapeutics. COB has received grant/research support from Bristol Myers Squibb; has received royalties from UpToDate; has received consulting fees from AbbVie, Bristol Myers Squibb, Janssen, Pfizer, Regeneron and Sanofi; has participated on a Data Safety Monitoring Board for Moderna; and is on the Executive Committee for OMERACT (unpaid). TWJH/the Department of Rheumatology LUMC has received research support/lecture fees/consultancy fees from Bristol Myers Squibb, Eli Lilly, Galapagos, Janssen and Pfizer. GC has received consulting fees, speaker fees and/or honoraria from AbbVie, Bristol Myers Squibb, Eli Lilly, Gema Biotech, Janssen and Pfizer. K-HGH and RW were employees of (at the time of analysis) and are shareholders in Bristol Myers Squibb; K-HGH is currently an employee of and shareholder in Johnson & Johnson. CW, SEC, and KL are employees of and shareholders in Bristol Myers Squibb. YE has received consulting fees from Bristol Myers Squibb. RF has received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Cambrian, GlaxoSmithKline, Novartis, Pfizer, Teijin and Vyne; has received honoraria from AbbVie and Pfizer; and has participated on Data Safety Monitoring Boards for AbbVie, GlaxoSmithKline and Pfizer.