Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Nov 28;25(1):491.
doi: 10.1186/s12883-025-04343-w.

A real-world retrospective study to assess the effectiveness and safety profile of siponimod in Chinese patients with relapsing forms of multiple sclerosis

Yao Zhang  1 , Hongbo Liu  2 , Zheng Li  3 , Ming Zhou  3 , Min Cai  3 , Lyra Liu  3 , Anne Lin  4 , Yan Xu  5
Affiliations

A real-world retrospective study to assess the effectiveness and safety profile of siponimod in Chinese patients with relapsing forms of multiple sclerosis

Yao Zhang et al. BMC Neurol. .

Abstract

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.

Keywords: Annualised relapse rate; Chinese patients; Real-world; Relapsing forms of multiple sclerosis; Siponimod.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study was conducted in accordance with the Declaration of Helsinki, and ethics approval was received from the Ethical Committee of Peking Union Medical College Hospital on 8 December 2022. All patients signed an Informed Consent Form prior to participation in the study. All data were anonymized prior to entry into the eCRFs. No experiments involving humans or human tissue samples were conducted during the study. Consent for publication: Not applicable. Competing interests: Lyra Liu, Min Cai, Ming Zhou, and Zheng Li are employees of China Novartis Institutes for Biomedical Research, China. Anne Lin is an employee of IQVIA, China Taiwan. IQVIA has received funding from Novartis for running this study and for medical writing support. Yan Xu, Yao Zhang, and Hongbo Liu have nothing to disclose.

Figures

Fig. 1
Fig. 1
Study schematic. aIdentification period: time in which patients meet the selection criteria. bIndex date: date of first recorded prescription of siponimod. cObservation period: from the index date to first of data abstraction date, patient withdrawal of consent, loss to follow-up, or death
See this image and copyright information in PMC

References

    1. Dutta R, Trapp BD. Relapsing and progressive forms of multiple sclerosis: insights from pathology. Curr Opin Neurol. 2014;27(3):271–8. 10.1097/wco.0000000000000094. - PMC - PubMed
    1. Efendi H. Clinically isolated syndromes: clinical characteristics, differential diagnosis, and management. Noro Psikiyatr Ars. 2015;52(Suppl 1):S1–11. 10.5152/npa.2015.12608. - PMC - PubMed
    1. Tian DC, Zhang C, Yuan M, Yang X, Gu H, Li Z, et al. Incidence of multiple sclerosis in china: a nationwide hospital-based study. Lancet Reg Health West Pac. 2020;1:100010. 10.1016/j.lanwpc.2020.100010. - PMC - PubMed
    1. Filippi M, Amato MP, Centonze D, Gallo P, Gasperini C, Inglese M, et al. Early use of high-efficacy disease–modifying therapies makes the difference in people with multiple sclerosis: an expert opinion. J Neurol. 2022;269(10):5382–94. 10.1007/s00415-022-11193-w. - PMC - PubMed
    1. Guo J, Wu J, Wang L, Liu H, Wu X, Yang H, et al. Treatment algorithms of relapsing multiple sclerosis: an exploration based on the available disease-modifying therapies in China. Ther Adv Neurol Disord. 2024;17:17562864241239117. 10.1177/17562864241239117. - PMC - PubMed

MeSH terms

Supplementary concepts

LinkOut - more resources