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来氟米特与特立氟胺治疗复发缓解型多发性硬化症的对比分析。

Comparative analysis of dimethyl fumarate and teriflunomide in relapsing-remitting multiple sclerosis.

机构信息

Neurology Clinic and Policlinic, Department of Head, Spine and Neuromedicine, MS Center and Translational Imaging in Neurology (ThINk) Basel, Department of Biomedical Engineering, University Hospital Basel and University of Basel, Basel, Switzerland.

Department of Clinical Research, Clinical Trial Unit, University Hospital Basel, Basel, Switzerland.

出版信息

Eur J Neurol. 2023 Dec;30(12):3809-3818. doi: 10.1111/ene.16044. Epub 2023 Aug 29.

Abstract

BACKGROUND AND PURPOSE

In relapsing-remitting multiple sclerosis (RRMS), analyses from observational studies comparing dimethyl fumarate (DMF) and teriflunomide showed conflicting results. We aimed to compare the effectiveness of DMF and teriflunomide in a real-world setting, where both drugs are licensed as first-line therapies for RRMS.

METHODS

We included all patients who initiated DMF or teriflunomide between 2013 and 2022, listed in the Swiss National Treatment Registry. Coarsened exact matching was applied using age, gender, disease duration, baseline Expanded Disability Status Scale (EDSS) score, time since last relapse, and relapse rate in the previous year as matching variables. Time to relapse and time to 12-month confirmed EDSS worsening were compared using Cox proportional hazard models.

RESULTS

In total, 2028 patients were included in this study, of whom 1498 were matched (DMF: n = 1090, 69.6% female, mean age 45.1 years, median EDSS score 2.0; teriflunomide: n = 408, 68.9% female, mean age 45.1 years, median EDSS score 2.0). Time to relapse and time to EDSS worsening was longer in the DMF than the teriflunomide group (hazard ratio 0.734, p = 0.026 and hazard ratio 0.576, p = 0.003, respectively).

CONCLUSION

Analysis of real-world data showed that DMF treatment was associated with more favorable outcomes than teriflunomide treatment.

摘要

背景与目的

在复发缓解型多发性硬化症(RRMS)中,比较二甲基富马酸(DMF)和特立氟胺的观察性研究分析结果存在矛盾。我们旨在比较 DMF 和特立氟胺在真实世界环境中的疗效,这两种药物均被批准为 RRMS 的一线治疗药物。

方法

我们纳入了 2013 年至 2022 年期间在瑞士国家治疗登记处中开始使用 DMF 或特立氟胺的所有患者。使用年龄、性别、疾病持续时间、基线扩展残疾状态量表(EDSS)评分、上次复发时间和前一年的复发率作为匹配变量进行粗糙精确匹配。使用 Cox 比例风险模型比较复发时间和 12 个月时确认的 EDSS 恶化时间。

结果

本研究共纳入 2028 例患者,其中 1498 例进行了匹配(DMF:n=1090,69.6%为女性,平均年龄为 45.1 岁,中位数 EDSS 评分为 2.0;特立氟胺:n=408,68.9%为女性,平均年龄为 45.1 岁,中位数 EDSS 评分为 2.0)。DMF 组的复发时间和 EDSS 恶化时间长于特立氟胺组(风险比 0.734,p=0.026 和风险比 0.576,p=0.003)。

结论

真实世界数据的分析表明,DMF 治疗与特立氟胺治疗相比,结局更为有利。

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