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富马酸二甲酯治疗多发性硬化症。

Diroximel fumarate in the treatment of multiple sclerosis.

机构信息

Department of Neurology, Hospital South West Jutland, University Hospital of Southern Denmark, Esbjerg, Denmark.

BRIDGE, Brain Research - Inter-Disciplinary Guided Excellence, Department of Regional Health Research, University of Southern Denmark, Esbjerg, Denmark.

出版信息

Neurodegener Dis Manag. 2020 Oct;10(5):267-276. doi: 10.2217/nmt-2020-0025. Epub 2020 Jul 20.

DOI:10.2217/nmt-2020-0025
PMID:32686599
Abstract

Diroximel fumarate (DRF) is a new emerging therapy for patients with multiple sclerosis. The levels of its active metabolite, monomethyl fumarate, are bioequivalent to the levels generated from dimethyl fumarate (DMF) treatment. The efficacy and safety profiles of DRF are expected to be similar to the well-established profiles of DMF. The metabolism of DRF leads to lower concentration of methanol in the small intestine than with DMF and thus reduced severity and frequency of gastrointestinal adverse events. DRF seems a promising alternative to DMF and other first-line therapies for multiple sclerosis. The current review is based on the two existing Phase III trials of DRF: the interim analysis of the EVOLVE-MS-1 trial and the completed EVOLVE-MS-2 trial.

摘要

富马酸二甲酯(DMF)是一种新出现的多发性硬化症治疗药物。其活性代谢物单甲基富马酸的水平与来自 DMF 治疗的水平生物等效。DRF 的疗效和安全性概况预计与 DMF 的既定概况相似。DRF 的代谢导致小肠中甲醇的浓度低于 DMF,从而降低胃肠道不良事件的严重程度和频率。DRF 似乎是 DMF 和其他多发性硬化症一线治疗的有前途的替代品。本综述基于 DRF 的两项现有 III 期试验:EVOLVE-MS-1 试验的中期分析和已完成的 EVOLVE-MS-2 试验。

相似文献

1
Diroximel fumarate in the treatment of multiple sclerosis.富马酸二甲酯治疗多发性硬化症。
Neurodegener Dis Manag. 2020 Oct;10(5):267-276. doi: 10.2217/nmt-2020-0025. Epub 2020 Jul 20.
2
Diroximel Fumarate Demonstrates an Improved Gastrointestinal Tolerability Profile Compared with Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III EVOLVE-MS-2 Study.在复发缓解型多发性硬化症患者中,与富马酸二甲酯相比,富马酸二罗西美显示出更好的胃肠道耐受性:随机、双盲、III期EVOLVE-MS-2研究结果。
CNS Drugs. 2020 Feb;34(2):185-196. doi: 10.1007/s40263-020-00700-0.
3
Diroximel fumarate (DRF) in patients with relapsing-remitting multiple sclerosis: Interim safety and efficacy results from the phase 3 EVOLVE-MS-1 study.富马酸二甲酯(DRF)治疗复发缓解型多发性硬化症患者的安全性和有效性:III 期 EVOLVE-MS-1 研究的中期结果。
Mult Scler. 2020 Nov;26(13):1729-1739. doi: 10.1177/1352458519881761. Epub 2019 Nov 4.
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Efficacy and Safety Outcomes with Diroximel Fumarate After Switching from Prior Therapies or Continuing on DRF: Results from the Phase 3 EVOLVE-MS-1 Study.在转换为先前的治疗或继续使用 DRF 后,富马酸二甲酯的疗效和安全性结果:来自 3 期 EVOLVE-MS-1 研究的结果。
Adv Ther. 2022 Apr;39(4):1810-1831. doi: 10.1007/s12325-022-02068-7. Epub 2022 Feb 24.
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Improving the Gastrointestinal Tolerability of Fumaric Acid Esters: Early Findings on Gastrointestinal Events with Diroximel Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis from the Phase 3, Open-Label EVOLVE-MS-1 Study.改善富马酸酯的胃肠道耐受性:来自 3 期、开放性 EVOLVE-MS-1 研究中复发缓解型多发性硬化患者使用二羟甲基富马酸酯的胃肠道事件的早期发现。
Adv Ther. 2019 Nov;36(11):3154-3165. doi: 10.1007/s12325-019-01085-3. Epub 2019 Sep 19.
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Diroximel fumarate in patients with relapsing-remitting multiple sclerosis: Final safety and efficacy results from the phase 3 EVOLVE-MS-1 study.富马酸二甲酯在复发缓解型多发性硬化症患者中的应用:III 期 EVOLVE-MS-1 研究的最终安全性和疗效结果。
Mult Scler. 2023 Dec;29(14):1795-1807. doi: 10.1177/13524585231205708. Epub 2023 Oct 31.
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Diroximel Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: NEDA-3 After Re-Baselining in the Phase 3 EVOLVE-MS-1 Study.富马酸二甲酯在复发缓解型多发性硬化症患者中的应用:在 EVOLVE-MS-1 研究中重新设定基准后的第 3 阶段 NEDA-3。
Adv Ther. 2024 Aug;41(8):3396-3406. doi: 10.1007/s12325-024-02901-1. Epub 2024 Jun 15.
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Health-Related Quality of Life with Diroximel Fumarate in Patients with Relapsing Forms of Multiple Sclerosis: Findings from Qualitative Research Using Patient Interviews.二羟麦角隐亭富马酸盐治疗复发性多发性硬化症患者的健康相关生活质量:采用患者访谈进行定性研究的结果。
Adv Ther. 2022 Jul;39(7):3199-3213. doi: 10.1007/s12325-022-02164-8. Epub 2022 May 13.
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Diroximel fumarate to treat multiple sclerosis.富马酸二甲罗昔康用于治疗多发性硬化症。
Drugs Today (Barc). 2020 Jul;56(7):431-437. doi: 10.1358/dot.2020.56.7.3151521.
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Worsening of lymphopenia in patients with multiple sclerosis when switched from dimethyl fumarate to diroximel fumarate.多发性硬化症患者从富马酸二甲酯换用富马酸二罗昔迈尔时淋巴细胞减少症恶化。
Mult Scler Relat Disord. 2024 Sep;89:105737. doi: 10.1016/j.msard.2024.105737. Epub 2024 Jun 27.

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Transcriptomic Analysis of Fumarate Compounds Identifies Unique Effects of Isosorbide Di-(Methyl Fumarate) on NRF2, NF-kappaB and IRF1 Pathway Genes.富马酸化合物的转录组分析确定了二(甲基富马酸)异山梨醇对NRF2、NF-κB和IRF1通路基因的独特作用。
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Monitoring the Redox Status in Multiple Sclerosis.监测多发性硬化症中的氧化还原状态。
Biomedicines. 2020 Oct 12;8(10):406. doi: 10.3390/biomedicines8100406.