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Observational Study
. 2025 Jun:98:106384.
doi: 10.1016/j.msard.2025.106384. Epub 2025 Mar 19.

Effectiveness of satralizumab in a real-world clinical setting in Japan: Interleukin-6 receptor inhibition in neuromyelitis optica spectrum disorder: A six-month interim analysis of a multicenter medical chart review

Kazuo Fujihara  1 , Noriko Isobe  2 , Katsuichi Miyamoto  3 , Masaaki Niino  4 , Jin Nakahara  5 , Satoshi Hattori  6 , Mamoru Yamamoto  7 , Izumi Kawachi  8 , Naoko Matsui  9 , Chiyoko Nohara  10 , Norito Kokubun  11 , Norio Chihara  12 , Tatsuro Misu  13 , Kazumasa Okada  14 , Katsuhisa Yamashita  15 , Tadashi Nagatsuka  15 , Hiroki Adachi  15 , Ichiro Nakashima  16
Affiliations
Free article
Observational Study

Effectiveness of satralizumab in a real-world clinical setting in Japan: Interleukin-6 receptor inhibition in neuromyelitis optica spectrum disorder: A six-month interim analysis of a multicenter medical chart review

Kazuo Fujihara et al. Mult Scler Relat Disord. 2025 Jun.
Free article

Abstract

Background: Satralizumab is approved in Japan for relapse prevention of neuromyelitis optica spectrum disorder (NMOSD) in aquaporin-4 immunoglobulin G-seropositive (AQP4[+]) patients. However, clinical trial data for Japanese patients are limited.

Methods: SAkuraBeyond, an ongoing real-world observational study (UMIN000050027), evaluates NMOSD relapse over 2.5 years among satralizumab-treated patients with AQP4[+] NMOSD in Japan (25 sites). Herein, we present a 26-week interim effectiveness analysis. Patient data were derived from medical chart review and electronic case report forms.

Results: Of the 125 enrolled patients who initiated satralizumab, 124 were included in the study (mean age, 51.1 years; female, 93.5 %; mean disease duration, 7.0 years). At week 26, 120 patients were relapse-free (12 withdrew from satralizumab). The annualized relapse rate [95 % confidence interval (CI)] was 0.069 [0.026-0.183] at week 26 after satralizumab initiation and 0.445 [0.342-0.580] within 52 weeks before satralizumab initiation. The relapse-free rate [95 % CI] at week 26 was 96.6 % [91.2-98.7]. Four patients had relapses, of whom 1 discontinued satralizumab. Three recorded a modified Rankin Scale of ≤3 (1 with unknown status). The mean oral glucocorticoid (GC) dose reduced from baseline to 26 weeks of satralizumab treatment; the GC dose was reduced in 71.3 % of patients treated with oral GC >0 mg at baseline. Azathioprine and tacrolimus doses could be reduced to 0 mg/day in 35.3 % and 26.2 % of relapse-free patients, respectively, at week 26.

Conclusion: The 6-month relapse-free rate after satralizumab treatment was 96.6 %. Satralizumab use permitted dose reduction of concomitant oral GC and immunosuppressants over 26-weeks.

Keywords: Effectiveness; Japan; Neuromyelitis optica spectrum disorder; Real-world; Satralizumab.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: K.F. serves as an advisor on the scientific advisory boards for Biogen, Mitsubishi Tanabe Pharma, Novartis, 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, Chugai Pharmaceutical, Roche, Alexion Pharmaceuticals, Viela Bio, Teijin, Asahi Kasei, Merck, and Takeda Pharmaceuticals; and has received grant-in-aid for scientific research from the Ministry of Education, Culture, Sports, Science and Technology of Japan and grant-in-aid for scientific research from the Ministry of Health, Labour and Welfare of Japan. N.I. has received speaker honoraria from Biogen Japan, Novartis, 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, and Kyowa Kirin. K.M. has received funding for speaker honoraria from Alexion Pharmaceuticals, Biogen, Chugai Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Novartis, and Teijin. M.N. has received funding for travel and/or speaker honoraria from Biogen, Mitsubishi Tanabe Pharma, Chugai Pharmaceutical, Alexion Pharmaceuticals, Takeda Pharmaceuticals, and Novartis. J.N. reports personal fees from AbbVie, Alexion Pharma GK, Asahi Kasei Medical, Biogen, Bristol Myers Squibb, Chugai Pharmaceutical, CSL Behring, Daiichi Sankyo, Eisai, Kyorin, Mitsubishi Tanabe Pharma, Novartis, Otsuka, Roche, Takeda Pharmaceuticals, and Teijin; research scholarships from AbbVie, Boehringer Ingelheim, Chugai Pharmaceutical, Daiichi Sankyo, EA Pharma, Eisai, JB, Mitsubishi Tanabe Pharma, Otsuka, Shionogi, Sumitomo Pharma, Teijin, and Tsumura; and grants from the Ministry of Education, Science and Technology of Japan; the Ministry of Health, Labour and Welfare of Japan; Biogen, and Chugai Pharmaceutical. S.H. has received speaker honoraria from Chugai Pharmaceutical. M.Y. has received speaker honoraria from Novartis. I.K. reports receiving funding for research, travel, and/or speaker's honoraria from Chugai Pharmaceutical, Novartis Pharma, Biogen, Alexion Pharmaceuticals, Mitsubishi Tanabe Pharma, Takeda Pharmaceuticals, Teijin Pharma, Argenx, and Daiichi Sankyo and is a scientific advisory board member for Mitsubishi Tanabe Pharma and Chugai Pharmaceutical. N.M. has received speaker honoraria from Chugai Pharmaceutical, Novartis, Alexion Pharmaceuticals, Teijin, Argenx, and UCB Japan. C.N. has received speaker honoraria from Novartis, Biogen Japan, Chugai Pharmaceutical, Mitsubishi Tanabe Pharma, Alexion Pharmaceuticals, Argenx, Eisai, Kowa Company. N.K. has received speaking fees from Chugai Pharmaceutical, CSL Behring, Mitsubishi Tanabe Pharma, Takeda Pharmaceuticals, Argenx Japan K.K., Novartis, and Alexion Pharmaceuticals. N.C. has received funding for travel and/or speaker honoraria from Biogen, Mitsubishi Tanabe Pharma, Chugai Pharmaceutical, Alexion Pharmaceuticals, AbbVie, and Novartis. T.M. has received speaker honoraria from Mitsubishi Tanabe Pharma, Novartis, Alexion Pharmaceuticals, Viela Bio, Teijin, Chugai Pharmaceutical, Sanofi, GE Healthcare Japan Co., CSL Behring, and Biogen Idec Japan; received research support from Cosmic Corporation, and Medical & Biological Laboratories; and received grant-in-aid for scientific research from the Ministry of Education, Culture, Sports, Science and Technology. K.O. serves as an advisor on the scientific advisory boards for Zenyaku and receives speaker honoraria from Alexion Pharmaceuticals, Argenx, Biogen, Chugai Pharmaceutical, Daiichi Sankyo, Mitsubishi Tanabe Pharma, and Novartis. K.Y., T.N., and H.A. are employees of Chugai Pharmaceutical. I.N. serves on the scientific advisory boards for Chugai Pharmaceutical, Biogen Japan, and Novartis and receives honoraria for speaking engagements with Chugai Pharmaceutical, Alexion Pharmaceuticals, Biogen Japan, Mitsubishi Tanabe Pharma, and Novartis.

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