A comparison of efficacy of subcutaneous interferon β-1a 44 μg, dimethyl fumarate and fingolimod in the real-life clinical practise – a multicenter observational study

皮下干扰素β-1a44μg，富马酸二甲酯和芬戈莫德在现实临床实践中的疗效比较 - 一项多中心观察研究

介绍：

多发性硬化是一种慢性炎性脱髓鞘和神经退行性疾病，影响中枢神经系统。干扰素（IFN）β-1a44μg，富马酸二甲酯（DMF）和芬戈莫德是用于治疗复发缓解型MS（RR MS）的药物。该项目的目的（来自登记处ReMuS的分析）是比较IFNβ-1a44μg，DMF和芬戈莫德在捷克共和国现实世界中RR MS患者的疗效。该治疗在复发后90天内开始。

患者和方法：共有279例RR MS患者在一线治疗期间复发一次（IFNβ-1a22μg，每周3次，IFNβ-1a30μg，每周1次，IFNβ-1b250μg）每隔一天给予teriflunomid，每天给予14mg醋酸格拉替雷，或每日给予20mg醋酸格拉替雷或每周3次给予醋酸格拉替雷40mg，并将其转换为用IFNβ-1a治疗44μg，DMF或芬戈莫德作为研究。观察到的参数是治疗后1年的年复发率（ARR），再次复发的时间，无复发患者的比例和扩大残疾状态量表（EDSS）的变化。

结果：我们发现在所有特定药物治疗变化后的1年观察期间观察到的结果有显著改善。 IFNβ-1a的比较44μg组（83名患者）与DMF或芬戈莫德组（196名患者）在DMF或芬戈莫德组中观察到的参数（ARR和EDSS的变化）显着改善。当我们使用倾向评分匹配方法（来自IFNβ-1a44μg组的83名患者与来自DMF或芬戈莫德组的83名患者）时，观察到持续改进参数保存两组治疗前后的变化,但观察组之间无显著差异。

结论：IFNβ-1a44μg，DMF和芬戈莫德证实了所选择的一组患者治疗升级的有效性，观察参数 - EDSS的变化和下次复发的时间。

关键词：

多发性硬化症 - 干扰素β-1a44μg - 富马酸二甲酯 - 芬戈莫德

Authors: Z. Pavelek ¹; L. Sobíšek ^2,3; D. Horáková ⁴; M. Vališ ¹
Authors place of work: Neurologická klinika LF UK a FN Hradec Králové ¹; Nadační fond IMPULS, Praha ²; Katedra statistiky a pravděpodobnosti, Vysoká škola ekonomická v Praze ³; Neurologická klinika a Centrum klinických neurověd 1. LF UK a VFN v Praze ⁴
Published in the journal: Cesk Slov Neurol N 2018; 81(4): 457-465
Category: Original Paper
doi: https://doi.org/10.14735/amcsnn2018457

Summary

Introduction:
Multiple sclerosis is a chronic inflammatory demyelinating and neurodegenerative disease affecting the CNS. Interferon (IFN) β-1a 44 μg, dimethyl fumarate (DMF) and fingolimod are established medications for the treatment of relapsing-remitting MS (RR MS). The aim of the project (analysis from registry ReMuS) was a comparison of the efficacy of IFN β-1a 44 μg, DMF and fingolimod in patients with RR MS in real world evidence in the Czech Republic. This treatment was started within 90 days after relapse.

Patients and methods:
A total of 279 patients with RR MS who experienced one relapse during the first line treatment (IFN β-1a 22 μg given 3× weekly, IFN β-1a 30 μg given 1× weekly, IFN β-1b 250 μg given each other day, teriflunomid 14 mg given daily, glatiramer acetate 20mg given daily or glatiramer acetate given 40mg given 3× weekly) and who were switched to the treatment with IFN β-1a 44 μg, DMF or fingolimod were included into the study. The observed parameters were annualized relapse rate (ARR), time to next relapse, proportion of relapse free patients and change in Expanded Disability Status Scale (EDSS) at 1-year after treatment.

Results:
We found out significant improvement in observed outcomes during 1-year observation after treatment change in all particular medications. Comparison of IFN β-1a 44 μg group (83 patients) vs. DMF or fingolimod group (196 patients) showed more significant improvement in observed parameters (ARR and change of EDSS) in DMF or fingolimod group. When we used propensity score matching method (83 patients from IFN β-1a 44 μg group vs. 83 patients from DMF or fingolimod group), the sustained improvement in observed parameters has persisted before and after change of treatment in both groups but no significant differences were observed between groups.

Conclusion:
IFN β-1a 44 μg, DMF and fingolimod proved the effectivness in escalation of treatment in the selected group of patients in observed parameters – change of EDSS and time to next relapse).

Key words:
multiple sclerosis – interferon β-1a 44 μg – dimethyl fumarate – fingolimod

The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study.

The Editorial Board declares that the manuscript met the ICMJE “uniform requirements” for biomedical papers.

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