ArticleNeurology and therapy2024
Safety and Effectiveness of Satralizumab in Japanese Patients with Neuromyelitis Optica Spectrum Disorder: A 6-month Interim Analysis of Post-marketing Surveillance.
Article in Neurology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed.
- Real-World Investigation of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disease.Annals of clinical and translational neurology · 2026Article
- The role of monoclonal antibodies against IL-6 or IL-6R in the treatment of thyroid eye disease.Reviews in endocrine & metabolic disorders · 2026Review
- Real-world safety of satralizumab in neuromyelitis optica spectrum disorder: a FAERS-based risk stratification study.Journal of neurology · 2026Article
- Long-term effectiveness and safety of satralizumab for neuromyelitis optica spectrum disorder in a real-world clinical setting in Japan: A 2.5-year final analysis of a multicenter medical chart review (The SAkuraBeyond Study).Multiple sclerosis (Houndmills, Basingstoke, England) · 2026Article
- Comparative analysis of adverse event reporting signals between Satralizumab and Inebilizumab in neuromyelitis optica spectrum disorder: A pharmacovigilance study using the FDA Adverse Event Reporting System.Intractable & rare diseases research · 2026Article
- IL-1β contributes to neurological disability in NMOSD AQP4 + Patients.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025Article
- Safety and Effectiveness of Satralizumab in Japanese Patients with Neuromyelitis Optica Spectrum Disorder: A 30‑Month Interim Analysis of Post‑marketing Surveillance.Neurology and therapy · 2025Article
- Incidence and Risk Factors for Serious Infections in Patients with Neuromyelitis Optica Spectrum Disorder: A Claims Database Study in Japan.Neurology and therapy · 2025Article
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Authors and funding
11 authors.
Funding
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Abstract
introductionSatralizumab, an anti-interleukin-6 receptor antibody, is approved in Japan for relapse prevention in neuromyelitis optica spectrum disorder (NMOSD) and is undergoing post-marketing surveillance (PMS) of clinical use. We aimed to describe the real-world safety and effectiveness of satralizumab in Japanese patients with NMOSD.
methodsThis is an ongoing PMS (planned completion: February 2027). This 6-month interim analysis assessed the safety and effectiveness of satralizumab in Japanese patients with NMOSD using data collected from August 2020 to July 2021.
resultsAmong 570 patients who participated, 523 (91.75%) were female and the mean ± standard deviation (SD) age was 52.4 ± 14.1 years. At baseline, NMOSD expanded disability status scale mean ± SD was 4.19 ± 2.19; 490 (85.96%) patients used glucocorticoids and 277 (48.59%) patients used immunosuppressants concomitantly. Of 570 satralizumab-treated patients, 85 (14.91%) had discontinued satralizumab treatment at 6 months. For the overall adverse drug reactions (ADRs), 76.22 (66.07-87.48) events/100 person-years occurred in 118 (20.70%) patients, and infections occurred in 28 (4.91%) patients. Serious infections occurred in 18 (3.15%) patients, with an event rate of 9.05 (5.80-13.47) events/100 person-years. Of the 24 events of serious infections, respiratory tract infections (29.17%; 7) and urinary tract infections (25.00%; 6) were the most common serious infection events. One fatal ADR (septic shock) suspected to be related to satralizumab was reported. The mean ± SD glucocorticoid dose reduced from 12.28 ± 10.17 mg/day at the index date to 8.11 ± 7.30 mg/day at 6 months. The Kaplan-Meier cumulative relapse-free rate (95% confidence interval) was 94.59% (92.25-96.23) at 6 months.
conclusionIn this study, satralizumab was found to be safe, well tolerated, and effective in patients with NMOSD in routine clinical practice. The results are consistent with those of previous clinical trials. The safety and effectiveness of satralizumab in Japanese patients with NMOSD will be analyzed over the 6-year surveillance period.
trial registrationUMIN Clinical Trials Registry, UMIN000041047.
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