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Different Fumaric Acid Esters Elicit Distinct Pharmacologic Responses.

Brian T Wipke1, Robert Hoepner1, Katrin Strassburger-Krogias1

  • 1From Biogen, Inc (B.T.W., A.M.T., D.G., S.S., M.S.B., R.H.S.), Cambridge, MA; Department of Neurology (R.H., M.P., A.C.), Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Department of Neurology (K.S.-K., R.G.), St. Josef Hospital, Ruhr University Bochum, Bochum, Germany.

Neurology(R) Neuroimmunology & Neuroinflammation
|January 20, 2021
PubMed
Summary

Dimethyl fumarate (DMF) and monoethyl fumarate (MEF) show distinct biological effects and biodistribution. Their combination therapy unpredictably alters responses, with MEF potentially contributing to lymphopenia in multiple sclerosis patients.

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Area of Science:

  • Pharmacology
  • Immunology
  • Drug Metabolism

Background:

  • Dimethyl fumarate (DMF) and monoethyl fumarate (MEF) are fumaric acid esters used in treating inflammatory conditions.
  • Understanding their distinct and combined biological effects is crucial for optimizing therapeutic strategies.

Purpose of the Study:

  • To compare the pharmacokinetic and pharmacodynamic effects of DMF and MEF, alone and in combination.
  • To investigate the translatability of these findings to patients with multiple sclerosis (MS).

Main Methods:

  • Rodent and cynomolgus monkey models were used to assess biodistribution and pharmacodynamic responses.
  • Transcriptional profiling identified differentially expressed genes.
  • A retrospective analysis of MS patients treated with DMF/MEF examined lymphocyte counts.

Main Results:

  • Monomethyl fumarate (MMF), the metabolite of DMF, showed higher brain penetration, while MEF concentrated in the kidney.
  • DMF uniquely activated the Nrf2 oxidative stress pathway, whereas MEF induced apoptosis.
  • DMF/MEF combination therapy led to unpredictable interactions and pronounced lymphocyte suppression in MS patients, particularly CD8+ T cells.

Conclusions:

  • Fumaric acid esters like DMF and MEF have different biodistribution and biological responses.
  • Combination therapy effects can be unpredictable, and MEF may contribute to lymphopenia via apoptosis induction in MS patients.