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Background <p>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.</p> Methods <p>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.</p> Results <p>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 &gt; 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.</p> Conclusions <p>This RW study confirmed favourable benefit–risk profile of siponimod in Chinese patients with RMS.</p>

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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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  • 发表日期：

    2025年11月28日

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  • Yao Zhang,
  • Hongbo Liu,
  • Zheng Li,
  • Ming Zhou,
  • Min Cai,
  • Lyra Liu,
  • Anne Lin,
  • Yan Xu

摘要

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.