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Article History

Received: 15 December 2023

Accepted: 2 April 2024

First Online: 29 April 2024

Declarations

:

: Derek Coombs and Ivan Lagunes were involved in the acquisition of data. Gerd R. Burmester, Jayne Stigler, Andrea Rubbert-Roth, Yoshiya Tanaka, Valderilio F. Azevedo, Derek Coombs, Ivan Lagunes, Ralph Lippe, Peter Wung, and Lianne S. Gensler were involved in the analysis and interpretation of the data, drafting the article, and revising it for critically important intellectual content, and approving the final version of manuscript.

: AbbVie Inc. (North Chicago, IL, USA) funded these trials (NCT03104400, NCT03104374, NCT03178487, NCT04169373) and participated in the trial design, research, analysis, data collection, interpretation of data, and the review and approval of the publication. AbbVie Inc. (North Chicago, IL, USA) funded the journal’s Rapid Service Fee.

: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (eg, protocols, clinical study reports, or analysis plans), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent, scientific research, and will be provided following review and approval of a research proposal, Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time after approval in the US and Europe and after acceptance of this manuscript for publication. The data will be accessible for 12 months, with possible extensions considered. For more information on the process or to submit a request, visit the following link: then select “Home”.

: These trials were conducted according to the International Conference on Harmonization guidelines, the Declaration of Helsinki principles, and applicable local country regulations. All study-related documents were approved by independent ethics committees and institutional review boards at each site. All patients provided written informed consent.

: Gerd R. Burmester has received honoraria for consulting and lecture from AbbVie, Janssen, Novartis, and Pfizer. Andrea Rubbert-Roth has received honoraria for lectures and consulting fees from AbbVie, Amgen, BMS, Chugai, Eli Lilly, Gilead, Janssen, Novartis, Roche, and Sanofi. Yoshiya Tanaka has received speaker fees and/or honoraria from Eli Lilly, AstraZeneca, Abbvie, Asahi Kasei, Gilead, Chugai, Boehringer-Ingelheim, GlaxoSmithKline, Eisai, Taisho, BMS, Pfizer and, Taiho; received research grants from Asahi Kasei, Mitsubishi-Tanabe, Eisai, Chugai, and Taisho. Yoshiya Tanaka is also an Editorial Board member of <i>Rheumatology and Therapy</i>, however was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Valderilio F. Azevedo has received funding for clinical trials, research grants, and/or honoraria for lectures and advice from AbbVie, Amgen, Bristol-Myers Squibb, Celltrion, Eli Lilly, Fresenius Kabi, GSK, Janssen, Novartis, Organon, Pfizer, and UCB. Jayne Stigler, Derek Coombs, Ivan Lagunes, Ralph Lippe, and Peter Wung are employees of AbbVie Inc. and may hold stock or options. Lianne S. Gensler has received grants from Novartis and UCB Pharma paid to her institution and consulting fees from AbbVie, Fresenius Kabi, Gilead, Janssen, Eli Lilly, MoonLake, Novartis, Pfizer, and UCB Pharma.