Ethics approval and consent to participate
The representative facility of this registry is Kyoto University, and this observational study was conducted in accordance with the Declaration of Helsinki, with approval by each ethics committee of seven institutes (Kyoto University, Osaka University, Osaka Medical College, Kansai Medical University, Kobe University, Nara Medical University, and Osaka Red Cross Hospital). This study was approved by the Institutional Ethical Review Board of Kyoto University Graduate School of Medicine (Kyoto University approval number R0357).
Consent for publication
Not applicable.
Availability of data and materials
The datasets used and/or analyzed in the current study are available from the corresponding author on reasonable request.
Competing interests
M.H., K. Murata, M.T., and H.I belong to Department of Advanced Medicine for Rheumatic Diseases that is supported by Nagahama City, Shiga, Japan, Toyooka City, Hyogo, Japan and five pharmaceutical companies (Mitsubishi Tanabe Pharma Co., Chugai Pharmaceutical Co. Ltd, UCB Japan Co. Ltd, AYUMI Pharmaceutical Co. and Asahi Kasei Pharma Corp.). M.H. has received a research and/or speaker fee from Bristol-Myers, Eisai, Eli Lilly, and Tanabe-Mitsubishi. M.T. has received research grants and/or speaker fees from AbbVie GK, Asahi-Kasei Pharma Corp., Astellas Pharma Inc., Ayumi Pharmaceutical Corp., Bristol-Myers Squibb, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Pfizer Inc., UCB Japan Co., Ltd., Janssen Pharmaceutical K.K., Mitsubishi-Tanabe Pharma Corp., Novartis Pharma K.K., and Taisho Pharma Co., Ltd. H.I. received a research grant and/or speaker fee from Bristol-Myers, Kyocera, Asahi-Kasei and Eisai. KE is affiliated with the Department of Musculoskeletal Regenerative Medicine, Osaka University, Graduate School of Medicine, which is supported by Taisho. KE has received research grants from Abbie, Asahi-Kasei, Astellas, Chugai, Eisai, Ono Pharmaceutical, and UCB Japan. KE has received payments for lectures from Abbvie, Asahi-Kasei, Astellas, Ayumi, Bristol-Myers Squibb, Chugai, Eisai, Eli Lilly, Janssen, Mitsubishi-Tanabe, Ono Pharmaceutical, Sanofi, and UCB Japan. AO received a speaker fee from Chugai, Ono Pharmaceutical, Eli Lilly, Mitsubishi-Tanabe, Asahi-Kasei, and Takeda. RH received a speaker fee from AbbVie. KO received a research grant and/or speaker fee from Abbvie, Astellas, Bristol-Myers Squibb, Eli Lily, Mitsubishi-Tanabe, Pfizer, and Takeda. The remaining authors have no financial conflicts of interest to disclose concerning this manuscript. The pharmaceutical companies had no role in the design of the study, the collection or analysis of the data, the writing of the manuscript, or the decision to submit the manuscript for publication.
Funding
The study reported in this publication uses the ANSWER cohort supported by grants from ten pharmaceutical companies (AbbVie G.K., Asahi-Kasei Pharma, AYUMI Pharmaceutical Co., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Ono Pharmaceutical Co., Sanofi, Teijin Healthcare Limited, and UCB Japan Co., Ltd.) and an information technology services company (CAC). This study is conducted as an investigator-initiated study. These companies have no roles in the study design, data collection, data analysis, data interpretation or writing of the report.
Author’s contributions
YN was responsible for the conception and design. YN, MH, KMurakami, KMurata, MT, HI, KE, KH, YH, MK, YS, HA, KA, AO, RH, KO, and SM contributed to the data extraction and interpretation. YN, WY, and KY contributed to the design and conduction of statistical analysis. YN and MH prepared the manuscript. MH supervised the manuscript. The authors read and approved the final manuscript.
Acknowledgements
The authors thank all medical staff at all institutions participating in the ANSWER cohort study for providing data.
Authors’ information
1Department of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Japan
2Department of Advanced Medicine for Rheumatic Diseases, Kyoto University Graduate School of Medicine, Kyoto, Japan
3Department of Health Information Management, Kurashiki Sweet Hospital, Okayama, Japan
4Department of Musculoskeletal Regenerative Medicine, Osaka University Graduate School of Medicine, Osaka, Japan
5Department of Internal Medicine IV, Division of Rheumatology, Osaka Medical College, Osaka, Japan
6Department of Rheumatology, Osaka Red Cross Hospital, Osaka, Japan
7First Department of Internal Medicine, Kansai Medical University, Osaka, Japan
8Department of Rheumatology and Clinical Immunology, Kobe University Graduate School of Medicine, Hyogo, Japan
9The Center for Rheumatic Diseases, Department of Orthopaedic Surgery, Nara Medical University, Nara, Japan
10Department of Medical Informatics, Wakayama Medical University, Wakayama, Japan