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Article History

Received: 18 April 2025

Accepted: 1 July 2025

First Online: 26 September 2025

Declarations

:

: Takashi Yamamura served on scientific advisory boards for Chugai Pharmaceutical, Roche, Biogen Japan, Biogen MA, Novartis Pharma, and Mitsubishi Tanabe Pharma; received research grants from Chugai Pharmaceutical, Novartis Pharma, Biogen Japan, Chiome Bioscience, Sanofi, UCB Japan, and Mebix; received research funding from Alexion G.K.; and received speaker honoraria from Chugai Pharmaceutical, Biogen Japan, Novartis Pharma, Mitsubishi Tanabe Pharma, Takeda Pharmaceuticals, Miyarisan Pharmaceutical, Alexion Pharmaceuticals, Sumitomo Pharma, and Teijin Pharma. Noriko Isobe has received speaker honoraria from Biogen Japan, Novartis Pharma, Alexion Pharmaceuticals, Chugai Pharmaceutical, Daiichi Sankyo, Takeda Pharmaceuticals, Ono Pharmaceutical, Eisai, Otsuka Pharmaceutical, Kyowa Kirin, EA Pharma, FP Pharmaceutical, Mitsubishi Tanabe Pharma, UCB Japan, Japan Blood Product Organization, Argenx, Sanofi, Amgen, and Alnylam. She has also received research grants for her department from Sumitomo Pharma, Chugai Pharmaceutical, Biogen Japan, and Kyowa Kirin. Izumi Kawachi received a grant from JSPS KAKENHI (grant number: 20K07899, JP23K06923) and the MHLW Research Program on Rare and Intractable Diseases, Grant/Award (JPMH 20FC1030, JPMH 23FC1009); funding for research, travel, and/or speaker honoraria from Chugai Pharmaceutical, Novartis Pharma, Biogen Japan, Alexion Pharmaceuticals, Mitsubishi Tanabe Pharma, Takeda Pharmaceuticals, Teijin Pharma, Argenx, UCB, and Daiichi Sankyo; and is a scientific advisory board member for Chugai Pharmaceutical and UCB. Chiyoko Nohara received speaker honoraria from Chugai Pharmaceutical, Biogen Japan, Novartis Pharma, Alexion Pharmaceuticals, and Mitsubishi Tanabe Pharma. Yusei Miyazaki received funding for travel and/or speaker honoraria from Alexion Pharmaceuticals, Biogen Japan, Chugai Pharmaceutical, Daiichi Sankyo, Mitsubishi Tanabe Pharma, Novartis Pharma, Takeda Pharmaceuticals, and Teijin Pharma. Minami Tomita, Yuta Kamei, and Katsuhisa Yamashita are employees of Chugai Pharmaceutical. Jin Nakahara received speaker honoraria from Alexion Pharmaceuticals, Chugai Pharmaceutical, Mitsubishi Tanabe Pharma, and Roche; served as a paid consultant for Alexion Pharmaceuticals, Chugai Pharmaceutical, Horizon, Mitsubishi Tanabe Pharma, and Roche; and received research grants from Chugai Pharmaceutical, Mitsubishi Tanabe Pharma, MEXT, and MHLW. Ichiro Nakashima serves on the scientific advisory boards for Biogen Japan, and Novartis Pharma; and receives honoraria for speaking engagements with Chugai Pharmaceutical, Alexion Pharmaceuticals, Biogen Japan, Mitsubishi Tanabe Pharma, and Novartis Pharma. Ichiro Nakashima is a member of advisory board of Chugai Pharmaceutical and received consultancy and speaker’s bureau fees from Chugai Pharmaceutical. Kazuo Fujihara serves as an advisor on the scientific advisory boards for Biogen, Mitsubishi Tanabe Pharma, Novartis Pharma, Chugai Pharmaceutical, Roche, Alexion Pharmaceuticals, Viela Bio/Horizon Therapeutics, UCB, Merck, Japan Tobacco, and AbbVie; has received funding for travel and speaker honoraria from Biogen, Eisai, Mitsubishi Tanabe Pharma, Novartis Pharma, Chugai Pharmaceutical, Roche, Alexion Pharmaceuticals, Viela Bio, Teijin, Asahi Kasei, Merck, and Takeda Pharmaceuticals; and has received Grants-in-Aid for scientific research from the Ministry of Education, Culture, Sports, Science and Technology of Japan and Grants-in-Aid for scientific research from the Ministry of Health, Labour and Welfare of Japan.

: The study followed the same ethical considerations as disclosed previously [ ]. This PMS study is ongoing in compliance with Japanese regulations (Ministerial Ordinance on Good Post-marketing Study Practice for Drugs [GPSP], MHLW Ministerial Ordinance No. 38, March 23, 2005), as is the case with general PMS studies in Japan. The study did not undergo review by the ethics committee of the participating medical institutions or follow procedures for informed consent, as this was not required for PMS studies according to Japanese regulations of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices. The study was designed to collect information from physicians in daily medical practice. Therefore, there are no disadvantages for patients because alternative treatments (such as those in the control group), placebo administration, or an increased frequency of hospital visits or tests beyond routine medical care are not being implemented. In addition, patients routinely have the opportunity to request treatment discontinuation or modification.