Dimethyl fumarate for treatment of multiple sclerosis: mechanism of action, effectiveness, and side effects

Ralf A Linker1, Ralf Gold

  • 1Department of Neurology, Friedrich-Alexander University Erlangen, Schwabachanlage 6, 91054, Erlangen, Germany, ralf.linker@uk-erlangen.de.

Insights

Dimethyl fumarate, an oral treatment for relapsing-remitting multiple sclerosis (MS), significantly reduces relapse rates and disability progression. This immunomodulatory drug also shows cytoprotective effects with a favorable safety profile.

Area of Science:

  • Neuroimmunology
  • Pharmacology

Background:

  • Relapsing-remitting multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system.
  • Current treatments aim to modulate the immune system and reduce disease activity.

Purpose of the Study:

  • To evaluate the efficacy and safety of a new oral formulation of dimethyl fumarate for treating relapsing-remitting MS.
  • To assess the impact of dimethyl fumarate on clinical relapses, disability progression, and MRI-detected lesions.

Main Methods:

  • Two pivotal phase III clinical trials (e.g., DEFINE) were conducted.
  • Participants received dimethyl fumarate (240 mg twice daily) or placebo.
  • Efficacy was measured by relapse rates, disability progression, and MRI lesion counts.

Main Results:

  • Dimethyl fumarate reduced relapse rates by approximately 50% compared to placebo.
  • Significant reduction in disability progression and MRI lesions (gadolinium-enhanced and T2) was observed.
  • The most common side effects were transient flushing and gastrointestinal irritation.

Conclusions:

  • Dimethyl fumarate is an effective oral treatment for relapsing-remitting MS, offering immunomodulatory and cytoprotective benefits.
  • The new formulation demonstrates a favorable safety profile, making it a valuable addition to MS treatment options.

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