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Article History

Received: 28 December 2023

Accepted: 6 June 2024

First Online: 16 July 2024

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; and received speaker honoraria from Chugai Pharmaceutical, Biogen Japan, Novartis Pharma, Mitsubishi Tanabe Pharma, Takeda Pharmaceutical, Miyarisan Pharmaceutical, Alexion Pharmaceuticals, Sumitomo Pharma, and Teijin Pharma. Noriko Isobe received speaker honoraria from Biogen Japan, Novartis Pharma, Alexion Pharmaceuticals, Mitsubishi Tanabe Pharma, UCB Japan, Takeda Pharmaceutical, Teijin Pharma, Argenx, and Chugai Pharmaceutical and research grants from Mitsubishi Tanabe Pharma, Novartis Pharma, Chugai Pharmaceutical, Biogen Japan, Sumitomo Pharma, CSL Behring, Eisai, Kyowa Kirin, and Japan Blood Products Organization. Izumi Kawachi received a grant from JSPS KAKENHI (grant no. 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, Alexion Pharmaceuticals, Mitsubishi Tanabe Pharma, Takeda Pharmaceutical, Teijin Pharma, Argenx, and Daiichi Sankyo; and is a scientific advisory board member for Chugai Pharmaceutical. Chiyoko Nohara has no competing interests to disclose. 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 Pharmaceutical, and Teijin Pharma. Minami Tomita, Takahiko Tsumuraya and Katsuhisa Yamashita are employees of Chugai Pharmaceutical. Jin Nakahara received speaker honoraria from Alexion Pharmaceuticals, Chugai Pharmaceutical, Mitsubishi Tanabe, 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 Chugai Pharmaceutical, Biogen Japan, and Novartis Pharma and receives honoraria for speaking engagements with Chugai Pharmaceutical, Alexion Pharmaceuticals, Biogen Japan, Mitsubishi Tanabe Pharma, and Novartis Pharma. Kazuo Fujihara serves as an advisor on scientific advisory boards for Biogen, Mitsubishi Tanabe Pharma, Novartis Pharma, Chugai Pharmaceutical, Roche, Alexion Pharmaceuticals, VielaBio/Horizon Therapeutics, UCB, Merck Biopharma, 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, VielaBio, Teijin Pharma, Asahi Kasei Medical, Merck, and Takeda Pharmaceutical; and has received the Grants-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan and the Grants-in-Aid for Scientific Research from the Ministry of Health, Welfare and Labour of Japan.

: The study was conducted in accordance with relevant regulations in Japan (Ministerial Ordinance on Good Post-Marketing Study Practice (GPSP), Ministry of Health, Labour and Welfare Ordinance Number 38, March 23, 2005). The study protocol was reviewed and approved by The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) prior to study initiation. 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 to ensure the registration of all patients with NMOSD and all patients set out as approval conditions in Japan. The patient data was collected after de-identification.