Experience of satralizumab administration in patients with neuromyelitis optica spectrum disorder in the Russian Federation

Introduction. Effectiveness and safety of satralizumab in the treatment of neuromyelitis optica spectrum disorders (NMOSD) have been demonstrated in randomized clinical trials and continue to be evaluated in the real clinical practice (RCP). Aim. To analyze the experience of satralizumab administration in Russian patients with NMOSD in the RCP. Materials and methods. The study was a multicenter retrospective. Analyzed data were taken from outpatient charts/medical records. Baseline clinical and demographic characteristics of patients with results on efficacy and safety of satralizumab treatment were assessed. Results. Data of 71 patients with ages ranging from 12 to 69 years at the start of satralizumab treatment were analyzed. 100% of patients had NMOSD with antibodies to aquaporin-4. At baseline 18.3% of patients were with highly active NMOSD by exacerbation frequency, 69% had previous relapse preventive treatment, 41% received low-dose glucocorticoids. The annualized relapse rate (ARR) during previous 2 years before treatment was 1.26. The median duration of satralizumab therapy was 15 [12; 24.5] months. 58 (82%) patients were relapse-free and included 9 (16%) persons with highly active NMOSD. The ARR decreased to 0.11 over 2 years of therapy (p < 0.001). In 8 (62%) of 13 patients with relapses first attack developed before 6 months of treatment and in 6 (46.2%) cases – during the “clustered period”, 11 (84.6%) patients did not receive low doses glucocorticoids or they were discontinued before 6 months of satralizumab therapy. Adverse events were reported in 19 (26.8%) patients. The neutropenia was the most common. 27 (84.4%) of 32 patients switched from rituximab to satralizumab were relapse-free with a favorable safety. Conclusions. The analysis of the experience on the satralizumab administration in the RCP demonstrated efficacy and favorable safety profile in Russian patients with NMOSD with antibodies to aquaporin-4 aged 12 years and older.