Dimethyl Fumarate: A Review in Relapsing-Remitting MS

Dimethyl fumarate (Tecfidera ® ) is approved for the treatment of relapsing forms of multiple sclerosis (MS). Based on evidence from the clinical trial and real-world settings, dimethyl fumarate is an effective treatment in this patient population, with benefits maintained over the longer term. In t...

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Bibliographic Details
Published in:Drugs (New York, N.Y.) N.Y.), 2019-12, Vol.79 (18), p.1965-1976
Main Author: Blair, Hannah A.
Format: Article
Language:English
Subjects:
Adis Drug Evaluation
Apoptosis
Cell adhesion & migration
Clinical trials
Clinical Trials, Phase III as Topic
Dimethyl Fumarate - administration & dosage
Dimethyl Fumarate - therapeutic use
Drug dosages
Genotype & phenotype
Health services
Humans
Immunosuppressive Agents - administration & dosage
Immunosuppressive Agents - therapeutic use
Internal Medicine
Lymphocytes
Magnetic resonance imaging
Medicine
Medicine & Public Health
Multiple sclerosis
Multiple Sclerosis, Relapsing-Remitting - drug therapy
Oral administration
Patient satisfaction
Patients
Pharmacokinetics
Pharmacology/Toxicology
Pharmacotherapy
Quality of life
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Summary:Dimethyl fumarate (Tecfidera ® ) is approved for the treatment of relapsing forms of multiple sclerosis (MS). Based on evidence from the clinical trial and real-world settings, dimethyl fumarate is an effective treatment in this patient population, with benefits maintained over the longer term. In the pivotal, placebo-controlled phase III DEFINE and CONFIRM trials in adults with relapsing-remitting multiple sclerosis (RRMS), twice-daily dimethyl fumarate reduced clinical relapse and MRI measures of disease activity and improved some aspects of health-related quality of life (HR-QoL). Reduced disability progression was also observed with dimethyl fumarate in DEFINE. Results in predominantly East Asian patients (APEX trial) were reflective of those seen in DEFINE and CONFIRM. Dimethyl fumarate had an acceptable tolerability profile. The most common adverse events were flushing and gastrointestinal events, which were of mild or moderate severity and appear to be largely manageable. Thus twice-daily dimethyl fumarate remains an effective treatment option for use in patients with RRMS, with the convenience of oral administration.
ISSN:0012-6667
1179-1950
DOI:10.1007/s40265-019-01229-3