We thank the patients who participated in the study.

Funding

Sponsorship for this study and Rapid Service Fee were funded by Bristol Myers Squibb.

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

All authors were involved in drafting the article or revising it critically for important intellectual content, and all authors approved the final version to be published. Study conception and design: PE, YT, VPB, TWJH, COB, SB, BPS, MN, RW, K-HGH, RF; acquisition of data: PE, YT, GC, BPS, K-HGH, RF; analysis and interpretation of data: PE, YT, VPB, TWJH, GC, COB, SB, BPS, MN, SEC, KLL, JZ, RW, K-HGH, RF.

Medical Writing, Editorial, and Other Assistance

We thank all the investigators who participated in the study. The authors acknowledge the support of Robert Cohen and Sandra Overfield as protocol managers. Professional medical writing and editorial assistance was provided by Fiona Boswell, PhD, at Caudex, and was funded by Bristol Myers Squibb. Prof. Emery is Versus Arthritis Professor of Rheumatology and Director of Leeds Biomedical Research Centre (BRC). This paper presents independent research supported by the National Institute for Health Research (NIHR) Leeds BRC. The views expressed are those of the authors and not necessarily those of the NIHR or the UK Department of Health and Social Care.

Disclosures

PE has received honoraria from Bristol Myers Squibb, Celltrion, GlaxoSmithKline, Lilly, Novartis, and Samsung (all ≤ $10,000); research grants from Bristol Myers Squibb, Lilly, Novartis, and Samsung (> $10,000); consulting fees from Boehringer Ingelheim, Bristol Myers Squibb, Lilly, and Novartis; and received support for meetings/travel from Novartis. YT has received honoraria from AbbVie, Boehringer Ingelheim, Chugai, Eli Lilly, Gilead, Mitsubishi Tanabe (all > $10,000), AstraZeneca, Bristol Myers Squibb, Eisai (all ≤ $10,000), Daiichi-Sankyo, GlaxoSmithKline, and Pfizer; and research grants from AbbVie, Asahi Kasei, Chugai, Daiichi Sankyo, Eisai, Takeda (all > $10,000), Boehringer Ingelheim (≤ $10,000), and Corrona. VPB has received consulting fees from Amgen, Bristol Myers Squibb, Genzyme, Gilead, Janssen, Sanofi, and UCB (all ≤ $10,000); is supported by NIH/fNIH (Accelerated Medicines Program; funds to institution; grants 1UH2AR067691-01 and GRANT11652401) and Cedar Hill; 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. TWJH (with the Department of Rheumatology of Leiden University Medical Center) has received research support/lecture fees/consultancy fees from Bristol Myers Squibb, Eli Lilly, Galapagos, Janssen, and Pfizer (all ≤ $10,000). The institution of GC has received grant/research support from Pfizer; and GC has received consulting fees and speaking fees and/or honoraria from AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Gema Biotech, Janssen, Pfizer, and Roche, and support for meeting attendance and/or travel from AbbVie and Pfizer, and participated on a Data Safety Monitoring Board or Advisory Board for AbbVie, Eli Lilly, Janssen, and Pfizer (all ≤ $10,000). COB has received grant/research support from Bristol Myers Squibb (> $10,000); has received royalties from Up-to-Date; has received consulting fees from AbbVie, Bristol Myers Squibb, Janssen, Pfizer, Regeneron, and Sanofi; has participated on a Data Safety Monitoring Board for Moderna (≤ $10,000); and is on the OMERACT executive committee (unpaid). SB, SEC, KLL, and JZ are employees of and shareholders in Bristol Myers Squibb. BPS was an employee of and shareholder in Bristol Myers Squibb at the time of analysis, and is currently an employee of and shareholder in Novo Nordisk. MN was an employee of and shareholder in Bristol Myers Squibb at the time of analysis. RW was an employee of Bristol Myers Squibb at the time of analysis and has stock options in Bristol Myers Squibb. KHGH was an employee of and shareholder in Bristol Myers Squibb at the time of analysis, and is currently an employee of and shareholder in Janssen R&D US. RF has received consulting fees from AbbVie, Bristol Myers Squibb, Pfizer (all > $10,000), Amgen, GlaxoSmithKline, Novartis (all ≤ $10,000), Cambrian, Teijin, and Vyne; has received honoraria from AbbVie and Pfizer; has participated on Data Safety Monitoring Boards for AbbVie, GlaxoSmithKline, and Pfizer; and is Editor-in-Chief of the journal, Rheumatology and Therapy.

Compliance with Ethics Guidelines

The study was conducted in accordance with the Declaration of Helsinki of 1964 and its later amendments, and the International Conference on Harmonization Good Clinical Practice guidelines. The protocol and patient-informed consent received institutional review board/independent ethics committee approval prior to study initiation. The 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. IRB approval numbers per site were not provided and are not available. All patients provided written informed consent prior to enrollment.

Data Availability

Bristol Myers Squibb policy on data sharing may be found at https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html. The datasets generated during and/or analyzed during the current study are available from Bristol Myers Squibb, as detailed in the data sharing policy, on reasonable request.

Prior Presentation

These data were previously presented at the 2018 ACR/ARHP Annual Scientific Meeting, Chicago (Emery P, et al., 19–24 October 2018, poster 563); 2019 ACR/ARHP Annual Scientific Meeting, Atlanta (Emery P, et al., 8–13 November 2019, poster L11); and EULAR 2020 eCongress, virtual (Emery P, et al., 3–6 June 2020, poster SAT0104).