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Dimethyl Fumarate: A Review in Relapsing-Remitting MS

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Abstract

Dimethyl fumarate (Tecfidera®) is an oral disease-modifying agent indicated for the twice-daily treatment of relapsing forms of multiple sclerosis (MS) and relapsing-remitting MS (RRMS). It displays immunomodulating and neuroprotective properties, both of which may contribute to its efficacy in these settings. In two phase III trials of 2 years’ duration (DEFINE and CONFIRM), twice-daily dimethyl fumarate reduced clinical relapse (both the proportion of patients with MS relapse and the annualized relapse rate), as well as MRI measures of disease activity, versus placebo in adults with RRMS; the drug also reduced disability progression relative to placebo in one of the two studies (DEFINE). Dimethyl fumarate had an acceptable tolerability profile in these trials, with the most common tolerability issues being flushing and gastrointestinal events, which appear to be largely manageable. In the DEFINE and CONFIRM extension (ENDORSE), a minimum of 5 years of treatment with the drug was associated with continued benefit and no new/worsening tolerability signals. Although additional active comparator data are needed, dimethyl fumarate is an effective twice-daily treatment option for use in adults with RRMS, with the convenience of oral administration and an acceptable long-term tolerability profile.

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Acknowledgments

During the peer review process, the manufacturer of dimethyl fumarate was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Correspondence to Emma D. Deeks.

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The preparation of this review was not supported by any external funding.

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Emma Deeks is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

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The manuscript was reviewed by: M. S. Freedman, University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, Canada; M. D. Kaufman, Knoxville Neurologic Clinic and University of Tennessee Medical Center, Knoxville, TN, USA.

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Deeks, E.D. Dimethyl Fumarate: A Review in Relapsing-Remitting MS. Drugs 76, 243–254 (2016). https://doi.org/10.1007/s40265-015-0528-1

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