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在瑞典多发性硬化症注册中心中对特立氟胺和富马酸二甲酯的比较研究。

A comparative study of teriflunomide and dimethyl fumarate within the Swedish MS Registry.

机构信息

Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.

Sanofi, Stockholm, Sweden.

出版信息

Mult Scler. 2022 Feb;28(2):237-246. doi: 10.1177/13524585211019649. Epub 2021 Jun 3.

DOI:10.1177/13524585211019649
PMID:34080926
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8795225/
Abstract

BACKGROUND

Teriflunomide and dimethyl fumarate (DMF) are first-line disease-modifying treatments for multiple sclerosis with similar labels that are used in comparable populations.

OBJECTIVES

The objective of this study was to compare the effectiveness and persistence of teriflunomide and DMF in a Swedish real-world setting.

METHODS

All relapsing-remitting multiple sclerosis (RRMS) patients in the Swedish MS registry initiating teriflunomide or DMF were included in the analysis. The primary endpoint was treatment persistence. Propensity score matching was used to adjust comparisons for baseline confounders.

RESULTS

A total of 353 teriflunomide patients were successfully matched to 353 DMF. There was no difference in the rate of overall treatment discontinuation by treatment group across the entire observation period (hazard ratio (HR) = 1.12; 95% confidence interval (CI) = 0.91-1.39; = 0.277; reference = teriflunomide). Annualised relapse rate (ARR) was comparable ( = 0.237) between DMF (0.07; 95% CI = 0.05-0.10) and teriflunomide (0.09; 95% CI = 0.07-0.12). There was no difference in time to first on-treatment relapse (HR = 0.78; 95% CI = 0.50-1.21), disability progression (HR = 0.55; 95% CI = 0.27-1.12) or confirmed improvement (HR = 1.17; 95% CI = 0.57-2.36).

CONCLUSION

This population-based real-world study reports similarities in treatment persistence, clinical effectiveness and quality of life outcomes between teriflunomide and dimethyl fumarate.

摘要

背景

特立氟胺和富马酸二甲酯(DMF)是多发性硬化症的一线治疗药物,具有相似的适应证,适用于相似的人群。

目的

本研究旨在比较特立氟胺和 DMF 在瑞典真实世界环境中的疗效和持久性。

方法

所有在瑞典多发性硬化症登记处开始使用特立氟胺或 DMF 的复发性缓解型多发性硬化症(RRMS)患者均纳入分析。主要终点是治疗的持久性。采用倾向评分匹配法调整基线混杂因素的比较。

结果

共 353 例特立氟胺患者与 353 例 DMF 患者成功匹配。在整个观察期间,两组的总体治疗停药率无差异(治疗组的危险比(HR)=1.12;95%置信区间(CI)=0.91-1.39;P=0.277;参照药物为特立氟胺)。DMF(0.07;95%CI=0.05-0.10)和特立氟胺(0.09;95%CI=0.07-0.12)的年复发率(ARR)相当(P=0.237)。首次治疗后复发的时间无差异(HR=0.78;95%CI=0.50-1.21)、残疾进展(HR=0.55;95%CI=0.27-1.12)或确认改善(HR=1.17;95%CI=0.57-2.36)。

结论

这项基于人群的真实世界研究报告了特立氟胺和 DMF 在治疗持久性、临床疗效和生活质量结果方面的相似性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/434e/8795225/04ef96a39cc1/10.1177_13524585211019649-fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/434e/8795225/41c4696ee801/10.1177_13524585211019649-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/434e/8795225/0df30b3c1355/10.1177_13524585211019649-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/434e/8795225/35dd6b4b815c/10.1177_13524585211019649-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/434e/8795225/e75c2ef970e8/10.1177_13524585211019649-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/434e/8795225/c1ddc1e48029/10.1177_13524585211019649-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/434e/8795225/04ef96a39cc1/10.1177_13524585211019649-fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/434e/8795225/41c4696ee801/10.1177_13524585211019649-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/434e/8795225/0df30b3c1355/10.1177_13524585211019649-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/434e/8795225/35dd6b4b815c/10.1177_13524585211019649-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/434e/8795225/e75c2ef970e8/10.1177_13524585211019649-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/434e/8795225/c1ddc1e48029/10.1177_13524585211019649-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/434e/8795225/04ef96a39cc1/10.1177_13524585211019649-fig6.jpg

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