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Comparative Effectiveness and Risk of Severe Infection in Adult Patients With MS Treated With Diroximel Fumarate

Ahmed Z Obeidat1, Michelle Betz2, Rebecca Straus Farber3

  • 1Medical College of Wisconsin, Milwaukee, WI, USA.

Advances in Therapy
|February 18, 2026
PubMed
Abstract

Insights

Diroximel fumarate (DRF) showed a lower risk of severe infections (SIs) compared to anti-CD20 monoclonal antibodies (mAbs) in multiple sclerosis (MS) patients. Annualized relapse rates (ARR) were similar between treatments, suggesting DRF may offer a safer profile.

Area of Science:

  • Neurology
  • Immunology
  • Pharmacology

Background:

  • Multiple sclerosis (MS) is a chronic, immune-mediated neurological disease.
  • Over 25 disease-modifying therapies (DMTs) exist, but efficacy and safety vary, especially in older populations.
  • Comparing diroximel fumarate (DRF) and anti-CD20 monoclonal antibodies (mAbs) for severe infections (SIs) and annualized relapse rate (ARR) in MS patients stratified by age is crucial.

Purpose of the Study:

  • To compare the risk of severe infections (SIs) and annualized relapse rate (ARR) between diroximel fumarate (DRF) and anti-CD20 monoclonal antibodies (mAbs).
  • To analyze these outcomes based on patient age (younger: <45 years; older: ≥45 years).

Main Methods:

  • Retrospective study using the Komodo Health Claims database.
  • Propensity score matching (1:1) of patients initiating DRF or anti-CD20 agents.
  • Stratification by age (<45 and ≥45 years) and identification of SIs and MS relapses via diagnosis codes and treatment claims.

Main Results:

  • 2894 matched patients with MS were included (1447 DRF, 1447 anti-CD20s).
  • DRF-treated patients had a significantly lower proportion of SIs at 12 and 24 months (p≤0.002 at 24 months).
  • Younger DRF patients had fewer SIs (p=0.005), older DRF patients had lower non-SI rates, and COVID-19-related SIs were lower in DRF patients (p<0.001). ARRs were similar.

Conclusions:

  • Diroximel fumarate (DRF) is associated with a significantly lower risk of severe infections (SIs) compared to anti-CD20 monoclonal antibodies (mAbs) in MS patients.
  • No significant difference in annualized relapse rates (ARR) was observed between the two treatment groups.
  • Further real-world studies are needed to evaluate DMT efficacy and safety, particularly for de-escalation strategies in aging MS populations.
Keywords:
AgeAnti-CD20 monoclonal antibodyDiroximel fumarateDisease-modifying therapyInfection

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