Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Sep 26.
doi: 10.1007/s40120-025-00799-7. Online ahead of print.

Safety and Effectiveness of Satralizumab in Japanese Patients with Neuromyelitis Optica Spectrum Disorder: A 30‑Month Interim Analysis of Post‑marketing Surveillance

Takashi Yamamura  1 , Noriko Isobe  2 , Izumi Kawachi  3   4 , Chiyoko Nohara  5 , Yusei Miyazaki  6 , Minami Tomita  7 , Yuta Kamei  7 , Katsuhisa Yamashita  8 , Jin Nakahara  9 , Ichiro Nakashima  10 , Kazuo Fujihara  11   12
Affiliations

Safety and Effectiveness of Satralizumab in Japanese Patients with Neuromyelitis Optica Spectrum Disorder: A 30‑Month Interim Analysis of Post‑marketing Surveillance

Takashi Yamamura et al. Neurol Ther. .

Abstract

Introduction: A large-scale post-marketing surveillance (PMS) study is ongoing to evaluate the safety and effectiveness of satralizumab over 6 years in Japanese patients with neuromyelitis optica spectrum disorder (NMOSD) in real-world settings. We present the results of a 30-month interim analysis of the study.

Methods: This PMS is being conducted across 234 sites in Japan. In this 30-month interim analysis, the end of the observation period was defined as either the date of data lock for the 30-month case report form for all patients or the last observation date for patients with satralizumab discontinuation. Primary outcomes include proportion of patients experiencing adverse drug reactions (ADRs), event rate, and oral glucocorticoid use. Secondary outcomes include time to relapse and relapse rate.

Results: Of 571 patients included (mean age: 52.4 years), 91.76% were female. At baseline, 85.98% of patients received oral glucocorticoids. ADRs were reported in 28.72% of patients (event rate: 27.69 events/100 person-years), with infections being most common (11.73%; 8.97 events/100 person-years). Univariate analysis showed that at 30 months, serious infections occurred in 6.83% of patients (5.00 events/100 person-years vs 8.13 events/100 person-years during 0-6 months) and were more frequent in patients aged ≥ 75 years, with diagnosis-to-treatment initiation duration ≥ 10 years, ≥ 3 relapses within 2 years, and Expanded Disability Status Scale score ≥ 6. Mean glucocorticoid dose decreased from 12.27 mg/day (baseline) to 3.48 mg/day (30 months). Kaplan-Meier cumulative relapse-free rate was 85.86% at 30 months. The annualized relapse rate was 0.08/person-year. Overall, 9.63% and 3.50% of patients discontinued treatment because of adverse events and relapses, respectively.

Conclusion: Serious infections were more common during the satralizumab treatment period, occurring most frequently within the first 6 months, highlighting the need for continuous monitoring of infections throughout satralizumab treatment. Satralizumab was found to be safe, without new safety concerns over 30 months. A reduction in concomitant immunosuppressive therapy usage was observed. The study demonstrated the effectiveness of satralizumab in preventing relapses in Japanese patients with NMOSD.

Trial registration: UMIN Clinical Trials Registry, UMIN000041047.

Keywords: Adverse drug reactions; Anti–IL-6 receptor antibody; Glucocorticoids; Infections; Long-term; Neuromyelitis optica spectrum disorder; Post-marketing surveillance; Relapse; Safety; Satralizumab.

PubMed Disclaimer

Conflict of interest statement

Declarations. Conflict of Interest: 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. Ethical Approval: The study followed the same ethical considerations as disclosed previously [16]. 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.

References

    1. Holroyd KB, Manzano GS, Levy M. Update on neuromyelitis optica spectrum disorder. Curr Opin Ophthalmol. 2020;31:462–8. - DOI - PubMed - PMC
    1. Wingerchuk DM, Banwell B, Bennett JL, Cabre P, Carroll W, Chitnis T, et al. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology. 2015;85:177–89. - DOI - PubMed - PMC
    1. Paolilo RB, da Paz JA, Apóstolos-Pereira SL, Rimkus CDM, Callegaro D, Sato DK. Neuromyelitis optica spectrum disorders: a review with a focus on children and adolescents. Arq Neuropsiquiatr. 2023;81:201–11. - DOI - PubMed - PMC
    1. Watanabe M, Isobe N, Niino M, Nakashima I, Matsushita T, Sakai Y, et al. Prevalence of, and disability due to, multiple sclerosis and neuromyelitis optica spectrum disorder in Japan by the fifth nationwide survey. Neurology. 2024;103:e209992. - DOI - PubMed
    1. Ma X, Kermode AG, Hu X, Qiu W. Risk of relapse in patients with neuromyelitis optica spectrum disorder: recognition and preventive strategy. Mult Scler Relat Disord. 2020;46:102522. - DOI - PubMed

LinkOut - more resources