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Long-term effects of delayed-release dimethyl fumarate in multiple sclerosis: Interim analysis of ENDORSE, a

Ralf Gold1, Douglas L Arnold2, Amit Bar-Or3

  • 1Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Bochum, Germany.

Multiple Sclerosis (Houndmills, Basingstoke, England)
|May 22, 2016
PubMed
Abstract

Insights

Dimethyl fumarate (DMF) treatment sustained low disease activity in relapsing-remitting multiple sclerosis (RRMS) patients over five years. This long-term study confirms DMF

Area of Science:

  • Neurology
  • Immunology
  • Pharmacology

Background:

  • Delayed-release dimethyl fumarate (DMF) has shown efficacy and a favorable benefit-risk profile in relapsing-remitting multiple sclerosis (RRMS).
  • The ENDORSE study is a long-term extension of the phase 3 DEFINE/CONFIRM trials for RRMS patients.

Purpose of the Study:

  • To report a 5-year interim analysis of efficacy and safety data from the ENDORSE trial.
  • To evaluate the long-term effects of DMF in RRMS patients.

Main Methods:

  • Patients initially randomized to DMF (240 mg twice or thrice daily) continued their dosage.
  • Patients initially on placebo or glatiramer acetate were re-randomized to DMF 240 mg twice or thrice daily.
  • Efficacy and safety outcomes were assessed over a minimum of 3 years in ENDORSE, following 2 years in DEFINE/CONFIRM.

Main Results:

  • Continuous low annualized relapse rates were observed in patients continuing DMF (BID/BID).
  • High percentages of patients were free from new or enlarging T2 hyperintense lesions, new T1 hypointense lesions, and gadolinium-enhanced lesions at year 5.
  • Adverse events were reported across treatment groups, with one case of progressive multifocal leukoencephalopathy in a patient with severe lymphopenia.

Conclusions:

  • DMF treatment is associated with sustained low clinical and MRI disease activity in RRMS patients.
  • The interim data suggest a sustained treatment benefit and an acceptable safety profile for DMF in long-term RRMS management.
Keywords:
DEFINEENDORSEExpanded Disability Status ScaleRelapsing–remitting multiple sclerosisdelayed-release dimethyl fumarate (DMF)

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