BMC neurology · 2025
A real-world retrospective study to assess the effectiveness and safety profile of siponimod in Chinese patients with relapsing forms of multiple sclerosis.
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Zhang Yao, Liu Hongbo, Li Zheng, Zhou Ming, Cai Min, Liu Lyra, Lin Anne, Xu Yan
Аннотация
BACKGROUND: Based 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.
METHODS: This 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.
RESULTS: Of 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.
CONCLUSIONS: This RW study confirmed favourable benefit-risk profile of siponimod in Chinese patients with RMS.
METHODS: This 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.
RESULTS: Of 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.
CONCLUSIONS: This RW study confirmed favourable benefit-risk profile of siponimod in Chinese patients with RMS.