Efficacy of delayed-release dimethyl fumarate in relapsing-remitting multiple sclerosis: integrated analysis of the phase 3 trials

Annals of Clinical and Translational Neurology
Vissia VigliettaRalf Gold

Abstract

Obtain a more precise estimate of the efficacy of delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) in relapsing multiple sclerosis (MS) and examine the consistency of DMF's effects across patient subgroups stratified by baseline demographic and disease characteristics. A prespecified integrated analysis of the randomized, double-blind, placebo-controlled, Phase 3 DEFINE and CONFIRM trials was conducted. The intent-to-treat population comprised 2301 patients randomized to receive placebo (n = 771) or DMF 240 mg twice daily (BID; n = 769) or three times daily (TID; n = 761). At 2 years, DMF BID and TID reduced the annualized relapse rate by 49% and 49% (both P < 0.0001), risk of relapse by 43% and 47% (both P < 0.0001), risk of 12-week confirmed disability progression by 32% (P = 0.0034) and 30% (P = 0.0059), and risk of 24-week confirmed disability progression by 29% (P = 0.0278) and 32% (P = 0.0177), respectively, compared with placebo. In a subset of patients (MRI cohort), DMF BID and TID reduced the mean number of new/enlarging T2-hyperintense lesions by 78% and 73%, gadolinium-enhancing lesion activity by 83% and 70%, and mean number of new nonenhancing T1-hypointense lesions by 65% and 64% (all P ...Continue Reading

References

Nov 12, 2005·Annals of Neurology·Chris H PolmanJerry S Wolinsky
Jan 24, 2012·The Journal of Pharmacology and Experimental Therapeutics·Robert H ScannevinKenneth J Rhodes
Sep 21, 2012·The New England Journal of Medicine·Robert J FoxUNKNOWN CONFIRM Study Investigators
Sep 21, 2012·The New England Journal of Medicine·Ralf GoldUNKNOWN DEFINE Study Investigators

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Citations

Dec 25, 2015·Neurotherapeutics : the Journal of the American Society for Experimental NeuroTherapeutics·Jens IngwersenHans-Peter Hartung
Oct 17, 2016·Neurology and Therapy·Sheena L DupuyRohit Bakshi
Jan 29, 2017·Journal of Investigative Medicine : the Official Publication of the American Federation for Clinical Research·Diana L Vargas, William R Tyor
Dec 9, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Lori MayerLisa Laing
Dec 22, 2017·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova·T E Shmidt
Aug 12, 2017·Nature Reviews. Neurology·Andrew J Solomon, John R Corboy
May 14, 2019·Expert Review of Neurotherapeutics·Brandon WilbanksMoses Rodriguez
Mar 23, 2017·European Journal of Neurology : the Official Journal of the European Federation of Neurological Societies·E HavrdovaJ L Marantz
Jun 21, 2019·Multiple Sclerosis Journal - Experimental, Translational and Clinical·Masahiro MoriShinichi Torii
Mar 3, 2017·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova·V M AlifirovaТ Е Shmidt
Feb 1, 2017·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova·E V PopovaE V Orlova
Mar 24, 2017·European Journal of Neurology : the Official Journal of the European Federation of Neurological Societies·R Lanzillo
Mar 20, 2018·Journal of Neurology·Roberta LanzilloUNKNOWN R.I.Re.MS study group
Jul 30, 2019·Frontiers in Immunology·Paulus S RommerOlaf Stuve
Feb 19, 2020·The Journal of Neuroscience Nursing : Journal of the American Association of Neuroscience Nurses·Trudy L CampbellCharles Minor

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Clinical Trials Mentioned

NCT00420212
NCT00451451

Software Mentioned

CONFIRM
DEFINE

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