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Introduction <p>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.</p> Methods <p>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).</p> Results <p>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&#xa0;year of treatment, DRF was associated with a significantly lower ARR compared to DMF (0.12 vs. 0.16; <i>p</i> = 0.03), representing a 21% reduction in relapse rate (rate ratio 0.79; 95%&#xa0;CI 0.64–0.97). At 2&#xa0;years of treatment, DRF maintained a lower ARR compared to DMF (0.11 vs. 0.16; <i>p</i> = 0.02), reflecting a 31% reduction in relapse rate (rate ratio 0.69; 95%&#xa0;CI 0.54–0.87).</p> Conclusion <p>The results of this real-world analysis indicate DRF may be more effective than DMF in reducing relapses over 1 and 2&#xa0;years of treatment in pwMS.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月30日

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  • 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

摘要

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.