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中国大湾区复发型多发性硬化症中国患者中特立氟胺随时间推移的持续有效性和安全性:来自真实世界数据的见解

Sustained Effectiveness and Safety Over Time of Teriflunomide in Chinese Patients with Relapsing Multiple Sclerosis in the Greater Bay Area of China: Insights from Real-World Data.

作者信息

Li Rui, Zhou Jing, Wu Haotian, Wang Yuge, Chen Juanjuan

机构信息

Department of Neurology, The Third Affiliated Hospital, Sun Yat-Sen University, No. 600 Tianhe Road, Tianhe District, Guangzhou, China.

Department of Neurology, The First People's Hospital of Foshan, Foshan, China.

出版信息

Neurol Ther. 2024 Aug;13(4):1117-1133. doi: 10.1007/s40120-024-00599-5. Epub 2024 May 16.

Abstract

INTRODUCTION

The real-world data on the medium- to long-term effectiveness and safety of teriflunomide in Chinese patients with relapsing multiple sclerosis (MS) is limited. Therefore, this study aims to assess the treatment outcomes of teriflunomide in Chinese patients with MS over a medium- to long-term period.

METHODS

This cohort study was carried out in three tertiary hospitals and regional MS centers located in the Greater Bay Area of China. We obtained the historical clinical data of patients who underwent teriflunomide treatment for at least 6 months. The primary objective was to evaluate the proportion of patients achieving no evidence of disease activity (NEDA)-3 status, which is characterized by the absence of relapses, confirmed disability worsening, and new or enlarging MRI lesions, over time. Secondary objectives included assessing the proportion of patients meeting each NEDA-3 criterion, changes in motor and cognitive function, as well as the incidence of adverse events and treatment discontinuations.

RESULTS

A total of 160 patients with MS were enrolled, including 125 patients treated with teriflunomide for at least 1 year (≥ 1-year completers) and 71 patients treated for at least 2 years (≥ 2-year completers). A total of 85.63% of the overall population achieved clinical NEDA-3 status at 6 months of teriflunomide treatment, and 71.20% of ≥ 1-year completers achieved NEDA-3 status at 12 months of teriflunomide treatment. The median timed 25-foot walk test (T25FW), nine-hole peg test (9-HPT), and paced auditory serial addition test (PASAT) results were relatively stable before and after treatment.

CONCLUSION

Medium- to long-term MS disease activity, as indicated by NEDA-3 status, is well controlled in patients treated with continuous teriflunomide treatment in real-world settings.

摘要

引言

关于特立氟胺在中国复发型多发性硬化症(MS)患者中的中长期有效性和安全性的真实世界数据有限。因此,本研究旨在评估特立氟胺在中国MS患者中长期的治疗效果。

方法

本队列研究在中国大湾区的三家三级医院和地区性MS中心进行。我们获取了接受特立氟胺治疗至少6个月的患者的历史临床数据。主要目标是评估随着时间推移达到无疾病活动证据(NEDA)-3状态的患者比例,该状态的特征是无复发、确认的残疾恶化以及新的或扩大的MRI病变。次要目标包括评估达到每个NEDA-3标准的患者比例、运动和认知功能的变化,以及不良事件和治疗中断的发生率。

结果

共纳入160例MS患者,其中125例接受特立氟胺治疗至少1年(≥1年完成者),71例接受治疗至少2年(≥2年完成者)。在特立氟胺治疗6个月时,总体人群中有85.63%达到临床NEDA-3状态,在特立氟胺治疗12个月时,≥1年完成者中有71.20%达到NEDA-3状态。治疗前后,25英尺计时步行试验(T25FW)、九孔插钉试验(9-HPT)和听觉序列加法试验(PASAT)的中位数结果相对稳定。

结论

在真实世界中,接受持续特立氟胺治疗的患者中,由NEDA-3状态所表明的中长期MS疾病活动得到了良好控制。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7782/11263525/379c4474c7ab/40120_2024_599_Fig1_HTML.jpg

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