Comparative Effectiveness of Diroximel Fumarate vs. Dimethyl Fumarate in Persons with Multiple Sclerosis: A US Claims Analysis of Relapse Outcomes.

IF 4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2026-04-30 DOI:10.1007/s12325-026-03608-1

Daniel Bandari, Devon Conway, Liang Dong, Nicholas Hong, Minxing Li, Anne Littlewood, Mike Roy, Sam Ulin, Chencan Zou, Babak Amerian-Williams, Nicholas Belviso, James B Lewin, Jason P Mendoza, Mirla Avila

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引用次数: 0

Abstract

Introduction: Diroximel fumarate (DRF) and dimethyl fumarate (DMF) are established disease-modifying therapies for relapsing multiple sclerosis (RMS). While DRF has demonstrated improved gastrointestinal tolerability compared to DMF, there is limited research evaluating whether this difference in tolerability translates into a difference in clinical effectiveness. This study evaluated the real-world effectiveness of DRF versus DMF on relapse outcomes in persons with MS (pwMS) in a large US population.

Methods: This retrospective cohort study utilized the Forian administrative claims database (January 1, 2018-June 30, 2025). Adult pwMS initiating DRF or DMF were identified and propensity score-matched (1:3 ratio) based on baseline demographic and clinical characteristics. Endpoints were assessed over 1- and 2-year follow-up periods. The primary endpoint was annualized relapse rate (ARR).

Results: The 1-year analysis included 1780 DRF-treated and 5340 DMF-treated pwMS; the 2-year analysis included 739 DRF-treated and 2217 DMF-treated pwMS. At 1 year of treatment, DRF was associated with a significantly lower ARR compared to DMF (0.12 vs. 0.16; p = 0.03), representing a 21% reduction in relapse rate (rate ratio 0.79; 95% CI 0.64-0.97). At 2 years of treatment, DRF maintained a lower ARR compared to DMF (0.11 vs. 0.16; p = 0.02), reflecting a 31% reduction in relapse rate (rate ratio 0.69; 95% CI 0.54-0.87).

Conclusion: The results of this real-world analysis indicate DRF may be more effective than DMF in reducing relapses over 1 and 2 years of treatment in pwMS.

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富马酸迪洛西梅尔与富马酸二甲酯在多发性硬化症患者中的比较疗效：美国对复发结果的索赔分析。

富马酸地洛昔梅尔（DRF）和富马酸二甲酯（DMF）是治疗复发性多发性硬化症（RMS）的有效药物。虽然与DMF相比，DRF已显示出更好的胃肠道耐受性，但评估这种耐受性差异是否转化为临床疗效差异的研究有限。本研究评估了DRF与DMF在美国大量人群中对多发性硬化症（pwMS）患者复发结果的实际有效性。方法：本回顾性队列研究使用了Forian行政索赔数据库（2018年1月1日至2025年6月30日）。确定成人pwMS启动DRF或DMF，并根据基线人口统计学和临床特征进行倾向评分匹配（1:3比例）。在1年和2年的随访期间评估终点。主要终点是年复发率（ARR）。结果：1年的分析包括1780例drf治疗和5340例dmf治疗的pwMS；2年的分析包括739例drf治疗的pwMS和2217例dmf治疗的pwMS。在治疗1年时，与DMF相比，DRF的ARR显著降低（0.12 vs. 0.16; p = 0.03），复发率降低21%（比率比0.79;95% CI 0.64-0.97）。在治疗2年时，与DMF相比，DRF保持较低的ARR (0.11 vs. 0.16; p = 0.02)，反映复发率降低31%（率比0.69;95% CI 0.54-0.87）。结论：现实世界的分析结果表明，在治疗1年和2年的pwMS中，DRF可能比DMF更有效地减少复发。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.