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Updated: Feb 7, 2026

Comprehensive Autopsy Program for Individuals with Multiple Sclerosis
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Safety and Efficacy of Dimethyl Fumarate in Multiple Sclerosis: An Italian, Multicenter, Real-World Study

Massimiliano Mirabella1, Luca Prosperini2,3, Matteo Lucchini4

  • 1Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy. massimiliano.mirabella@unicatt.it.

CNS Drugs
|July 20, 2018
PubMed
Abstract

Insights

Delayed-release dimethyl fumarate (DMF) shows good short-term safety and effectiveness in real-world relapsing-remitting multiple sclerosis (RRMS) patients. This supports its use as an early treatment option for MS.

Area of Science:

  • Neurology
  • Immunology
  • Pharmacology

Background:

  • Two Phase III trials confirmed the efficacy of delayed-release dimethyl fumarate (DMF) for relapsing-remitting multiple sclerosis (RRMS).
  • Real-world data on the safety and effectiveness of DMF in RRMS are limited.

Purpose of the Study:

  • To evaluate the safety and tolerability of DMF in RRMS patients in a real-world setting.
  • To identify patient variables associated with improved clinical and radiological outcomes.

Main Methods:

  • Collected clinical and MRI data from 1089 RRMS patients initiating DMF between 2012-2017 across seven Italian MS clinics.
  • Assessed DMF discontinuation rates, adverse events, annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) changes, and radiological activity.
  • Investigated baseline variables linked to clinical and radiological outcomes.

Main Results:

  • DMF discontinuation occurred in 19.5% of patients, primarily due to tolerability (103) and disease activity (63). Lymphopenia affected 16.5% of patients.
  • ARR decreased from 0.55 to 0.13; mean EDSS change was +0.08 per year.
  • Clinical/radiological activity was associated with younger age, higher baseline EDSS, more baseline Gd-enhancing lesions, and prior MS treatment exposure.

Conclusions:

  • Real-world data confirm the short-term safety, tolerability, and effectiveness of DMF in RRMS.
  • Findings support the use of DMF as an early treatment strategy for multiple sclerosis.

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