Oral BG-12 (dimethyl fumarate) for relapsing–remitting multiple sclerosis: a review of DEFINE and CONFIRM
| Autor: | Eva Havrdova, Michael Hutchinson, Ralf Gold, Marianne T. Sweetser, Katherine Dawson, Nuwan Kurukulasuriya, Kartik Raghupathi |
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| Rok vydání: | 2013 |
| Předmět: |
Male
Oncology medicine.medical_specialty Disease Pharmacology law.invention chemistry.chemical_compound Multiple Sclerosis Relapsing-Remitting Fumarates Randomized controlled trial law Internal medicine Humans Medicine Pharmacology (medical) Adverse effect Dimethyl fumarate business.industry Multiple sclerosis Incidence (epidemiology) General Medicine medicine.disease Relapsing remitting chemistry Expert opinion Female Peptides business Immunosuppressive Agents |
| Zdroj: | Expert Opinion on Pharmacotherapy. 14:2145-2156 |
| ISSN: | 1744-7666 1465-6566 |
| DOI: | 10.1517/14656566.2013.826190 |
| Popis: | Multiple sclerosis (MS) is an autoimmune neurodegenerative disease of the central nervous system involving inflammation, chronic demyelination and axonal loss. MS affects more than 2 million people worldwide.This article aims to summarize the findings from two pivotal 2-year, randomized, double-blind, placebo-controlled, Phase III studies of BG-12 (dimethyl fumarate) for relapsing-remitting MS (RRMS): DEFINE (Determination of the Efficacy and Safety of Oral Fumarate in RRMS) and CONFIRM (Comparator and an Oral Fumarate in RRMS). Results from both studies demonstrated that BG-12 provides clinical and radiological efficacy over 2 years across a range of outcomes. These results were apparent as early as 12 weeks and sustained over the course of both studies. BG-12 was found to have an acceptable safety profile, with a similar overall incidence of adverse events across all treatment groups.The combination of robust efficacy, ease of administration and established safety profile is unique to a new therapy in MS. Findings from the pivotal Phase III studies support BG-12 as a potential initial oral treatment for patients with RRMS or as an alternative to other currently available therapies. |
| Databáze: | OpenAIRE |
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