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Expanding spectrum of opportunistic infections associated with dimethyl fumarate

Tiffany Kim1, David Croteau1, Allen Brinker1

  • 1Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, MD, USA.

Multiple Sclerosis (Houndmills, Basingstoke, England)
|December 10, 2020
PubMed
Abstract

Insights

Dimethyl fumarate (DMF) is linked to serious opportunistic infections (OIs) beyond progressive multifocal leukoencephalopathy (PML). Monitoring for OIs is crucial during DMF treatment, irrespective of lymphocyte counts.

Area of Science:

  • Neurology
  • Infectious Diseases
  • Pharmacovigilance

Background:

  • Dimethyl fumarate (DMF) prescribing information currently only details progressive multifocal leukoencephalopathy (PML).
  • There is a need to identify other opportunistic infections (OIs) associated with DMF treatment.

Purpose of the Study:

  • To identify and describe opportunistic infections (OIs) associated with dimethyl fumarate (DMF) therapy, excluding PML.
  • To characterize the nature and timing of these OIs.

Main Methods:

  • Searched the FDA Adverse Event Reporting System (FAERS) database.
  • Conducted a comprehensive search of the medical literature.

Main Results:

  • Identified 34 cases of serious OIs causally associated with DMF.
  • Included 11 central nervous system (CNS) infections and 23 extra-CNS infections.
  • Observed six OIs in patients with normal absolute lymphocyte counts; median latency to OI was 13 months.

Conclusions:

  • Dimethyl fumarate (DMF) is associated with an increased risk of developing serious opportunistic infections (OIs).
  • These OIs may necessitate invasive diagnostic and/or therapeutic interventions.
  • Continuous patient monitoring for OIs is recommended during DMF treatment, irrespective of absolute lymphocyte counts.
Keywords:
Multiple sclerosisdimethyl fumarateimmunology

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