ArticleBMC neurology2025
A real-world retrospective study to assess the effectiveness and safety profile of siponimod in Chinese patients with relapsing forms of multiple sclerosis.
Article in BMC neurology, 2025. 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
backgroundBased on its favourable benefit-risk profile in clinical trials, siponimod was approved in China in 2020 for relapsing forms of multiple sclerosis (RMS). We evaluated its real-world (RW) effectiveness and safety profile in patients with RMS in China.
methodsThis was a retrospective chart review of adults (≥ 18 years) with RMS receiving their first siponimod prescription (index date) between 01 August 2020 and 01 August 2022 at two hospitals in China. Inclusion criteria were ≥ 3 months of siponimod treatment and ≥ 1 clinical visit after the index date. Annualised relapse rate (ARR), proportion of relapse-free patients, proportion of patients free of MRI activity, and incidence of treatment-emergent adverse events (TEAEs) were evaluated.
resultsOf 113 included patients (mean age, 37.2 years; 64.6% women), 70 (61.9%) received ≥ 1 disease-modifying treatment (other than siponimod) before index. Most patients (89.4%) were diagnosed with relapsing-remitting multiple sclerosis, and 85.0% remained on siponimod for > 12 months. Overall, 16 patients (14.2%) experienced ≥ 1 relapse (14 patients had one relapse and two had two relapses), and 85 patients (75.2%) remained relapse-free. Of 46 patients with ≥ 1 MRI assessment, 36 (78.3%) were free of MRI activity. The mean group-based ARR was 0.1 per patient-year. Overall, 71 patients (62.8%) experienced ≥ 1 TEAE, and 56 (49.6%) had TEAEs related to siponimod. The most common TEAEs by preferred term were increased alanine transaminase (23.0%) and increased aspartate transaminase (13.3%). No new safety signals were identified.
conclusionsThis RW study confirmed favourable benefit-risk profile of siponimod in Chinese patients with RMS.
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