ArticleMultiple sclerosis (Houndmills, Basingstoke, England)2026
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).
Article in Multiple sclerosis (Houndmills, Basingstoke, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeTo evaluate the real-world effectiveness and safety of satralizumab over 2.5 years using medical data charts of satralizumab-treated Japanese patients with aquaporin-4 immunoglobulin-G seropositive neuromyelitis optica spectrum disorder (AQP4[+] NMOSD). MAJOR
findingsOverall, 124 patients were evaluated (mean ± standard deviation: age, 51.1 ± 14.0 years; disease duration, 7.0 [6.0] years). At baseline, 72.6%, 16.9%, and 35.5% of patients received oral glucocorticoids (GCs), azathioprine (AZA), and tacrolimus (TAC), respectively. The annualized relapse rate (ARR [95% confidence interval]) decreased from 0.45 (0.34-0.58) within 52 weeks before satralizumab initiation to 0.03 (0.02-0.07) after 130 weeks of satralizumab initiation; relapse-free rate was 91.8% at 130 weeks. Nine patients had nine relapses; seven were re-administered satralizumab after relapse. At 130 weeks, 48.8% of relapse-free patients were not receiving oral GCs (89.3% received ⩽5 mg/day); mean oral GC dose reduced from 10.3 to 2.5 mg/day. In patients receiving AZA and TAC at baseline, 80.0% and 47.1% were no longer receiving AZA and TAC at 130 weeks, respectively. Serious drug reactions occurred in 9.7% of patients (serious infections, 6.5%).
conclusionThe real-world relapse-free rate at 2.5 years was 91.8% (ARR = 0.03) in satralizumab-treated patients with AQP4[+] NMOSD, supporting the relapse-preventive effect of satralizumab without new safety concerns. REGISTRATION NUMBER: UMIN000050027.
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