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- Published online January 15, 2025.
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© 2025 The Journal of Rheumatology
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- Christopher J. Edwards,
- Gerhard Krönke,
- Jérôme Avouac,
- Zhanguo Li,
- Fabrizio Conti,
- Alejandro Balsa,
- Daojun Mo,
- Ewa Haladyj,
- Peter Fischer,
- Masaru Tanaka,
- Yasushi Takita,
- Kohei Hagimori and
- Tsutomu Takeuchi
- C.J. Edwards, MD FRCP, NIHR Southampton Clinical Research Facility, University Hospital Southampton, Southampton, United Kingdom.
- G. Krönke, MD, Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
- J. Avouac, MD PhD, Universitè de Paris, Paris, France.
- Z. Li, MD PhD, Peking University People's Hospital, Beijing, China.
- F. Conti, MD PhD, Sapienza University of Rome, Rome, Italy.
- A. Balsa, MD PhD, Hospital Universitario La Paz, Institute for Health Research IdiPAZ, Spain.
- D. Mo, MD PhD, Eli Lilly and Company, Indianapolis, Indiana, United States.
- E. Haladyj, MD PhD, Eli Lilly and Company, Indianapolis, Indiana, United States.
- P. Fischer, MD, Eli Lilly and Company, Indianapolis, Indiana, United States.
- Masaru Tanaka, MPharm, Yasushi Takita, MSc, Kohei Hagimori, MSc, Eli Lilly Japan.
- Yasushi Takita, MSc, Kohei Hagimori, MSc, Eli Lilly Japan K.K., Japan.
- Kohei Hagimori, MSc, Eli Lilly Japan K.K., Japan.
- T. Takeuchi, MD PhD, Saitama Medical University, Saitama, Japan.
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Contributions: All authors contributed to data interpretation, drafting, and critical revision (review and editing) of the work. D.M., E.H., P.F., K.H., Y.T., and M.T. also contributed to conception, design, acquisition, and analysis.
Funding (grants or industrial support): This study was funded by Eli Lilly and Company.
Competing Interests: Christopher J Edwards received clinical grants from Eli Lilly and Company; payment of honoraria for lecture fees and consultancy related to the subject area covered in the manuscript from Abbvie, Alpha Sigma, BMS, Fresenius, Galapagos, Gilead, Janssen, Lilly, Pfizer, MSD, Novartis, Roche, Sanofi, and UCB; and support for attending meetings and/or travel for Eli Lily and Company.
Gerhard Krönke received consulting fees from Eli Lilly and Company; payment for lectures from Eli Lilly and Company; and support for attending meetings and/or travel from Eli Lilly and Company.
Jérôme Avouac received grants or contracts from Pfizer, Bristol Myers Squibb, Novartis, Galapagos/Alfasigma, and Nordic Pharma; consulting fees from Abbvie, Sanofi, and Nordic Pharma; payment or honoraria for lectures, presentations, and/or speakers bureaus from Galapagos, Abbvie, Bristol Myers Squibb, Sanofi, Roche-Chugai, Nordic Pharma, Biogen, Fresenius Kabi, MSD, Celltrion, Medac, and Novartis; support for attending meetings and/or travel from Celltrion, Abbvie, and Novartis; and, participated on a Data Safety Monitoring Board or Advisory Board for Abbvie, Pfizer, Galapagos/Alfasigma, and BMS.
Zhanguo Li does not report any conflict of interest.
Fabrizio Conti received clinical grants from Eli Lilly and Company; speaker fees from Eli Lilly and Company, Biogen, BMS, Galapagos, Abbvie, Pfizer, and UCB; and support for attending meetings and/or travel for Eli Lily and Company.
Alejandro Balsa received support for the present manuscript from Eli Lilly and Company; grants or contracts from Abbvie, UCB, and Pfizer; consulting fees from Eli Lilly and Company, UCB, Abbvie, Pfizer, Galapagos, Sanofi, Nordic Pharma, Sandoz, Gebro, BMS; payment or honoraria for lectures, presentations, and/or speakers bureaus from Eli Lilly and Company, UCB, Abbvie, Pfizer, Galapagos, Sanofi, Nordic Pharma, Sandoz, Gebro, and BMS; and participated in a Data Safety Monitoring Board or Advisory Board for Eli Lilly and Company and UCB; and received support for attending meetings and/or travel for Eli Lily and Company.
Daojun Mo, Ewa Haladyj, and Peter Fischer are employees and shareholders of Eli Lilly and Company.
Masaru Tanaka, Yasushi Takita, and Kohei Hagimori are employees of Eli Lilly Japan K.K. and shareholders of Eli Lilly and Company.
Tsutomu Takeuchi received consulting fees from Abbvie, Mitsubishi-Tanabe Pharma Corp., Eli Lilly Japan K.K., Taisho Pharmaceutical Holding Co. LTD., and Gilead Sciences, Inc.; payment or honoraria for lectures, presentations, and/or speakers bureaus from AstraZeneca K.K., Astellas Pharma Inc., AbbVie, Mitsubishi-Tanabe Pharma Corp., Pfizer Japan Inc., Chugai Pharmaceutical Co, Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Janssen Pharmaceutical K.K., Taisho Pharmaceutical Holding Co. LTD, and Gilead Sciences, Inc.
Ethics (or reason for IRB exemption) and Patient Consent: Consent for participation in the step-down sub-study was obtained at the time of entry into RABEYOND. Lilly or its representatives provided data, laboratory, and site monitoring services. All authors participated in data analysis and interpretation, reviewed drafts and final manuscript and provided critical comments. The authors vouch for the veracity and completeness of the data and data analyses.
The study was designed by the sponsor, Eli Lilly and Company, an academic advisory board including non-Lilly authors of this manuscript, and Incyte. This study was approved by the institutional review board or ethics committee for each center involved in the clinical trial. It was conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines. All patients provided written informed consent before the first study procedure in RA-BEYOND.
- Corresponding author: Professor Christopher J Edwards, NIHR Southampton Clinical Research Facility, University Hospital Southampton, Southampton, Tremona Road, SO16 6YD, United Kingdom. cedwards@soton.ac.uk.