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Dimethyl fumarate (Tecfidera): a new oral agent for multiple sclerosis
Jineane V Venci1, Mona A Gandhi
1University of Rochester Medical Center/Strong Memorial Hospital, Rochester, NY, USA.
The Annals of Pharmacotherapy
|November 22, 2013
Summary
Oral dimethyl fumarate (DMF) offers a new treatment option for relapsing multiple sclerosis (MS), demonstrating significant efficacy in reducing relapses. While generally safe, some patients experienced flushing or gastrointestinal issues.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system.
- Oral therapies offer convenience for patients with relapsing forms of MS.
- Dimethyl fumarate (DMF) has emerged as a novel therapeutic agent.
Purpose of the Study:
- To evaluate the clinical evidence for the safety, efficacy, and utility of oral DMF in treating MS.
- To synthesize data from clinical trials and regulatory information regarding DMF for MS.
Main Methods:
- Comprehensive literature search of PubMed, ClinicalTrials.gov, and FDA resources.
- Inclusion of phase III trials and review articles on DMF for MS.
- Abstraction and synthesis of safety and efficacy data.
Main Results:
- Oral DMF demonstrated significant efficacy in two phase III trials (DEFINE, CONFIRM), reducing relapse rates by 34-49% and annualized relapse rates by 44-53% compared to placebo.
- The incidence of serious adverse events was comparable to placebo.
- Discontinuation rates due to intolerable flushing (3%) and gastrointestinal effects (4%) were noted.
Conclusions:
- Oral DMF was approved in March 2013 as an oral treatment for relapsing MS.
- Efficacy appears comparable to existing oral MS therapies.
- DMF may offer a favorable safety profile compared to other oral agents.
Keywords:
ambulatory careclinical pharmacydrug informationevidence-based practicemultiple sclerosisneurologyMore Related Videos
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