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Management Strategies to Facilitate Optimal Outcomes for Patients Treated with Delayed-release Dimethyl Fumarate

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Abstract

Delayed-release dimethyl fumarate is an oral disease-modifying therapy that has demonstrated significant efficacy in adults with relapsing–remitting multiple sclerosis. Incidences of flushing and gastrointestinal adverse events are common in the first month after delayed-release dimethyl fumarate initiation. Our objective was to propose mitigation strategies for adverse events related to initiation of delayed-release dimethyl fumarate in the treatment of patients with multiple sclerosis. Studies of individually developed mitigation strategies and chart reviews were evaluated. Those results, as well as mitigation protocols developed at multiple sclerosis care centers, are summarized. Key steps to optimize the effectiveness of delayed-release dimethyl fumarate treatment include education prior to and at the time of delayed-release dimethyl fumarate initiation, initiation dose protocol gradually increasing to maintenance dose, dietary suggestions for co-administration with food, gastrointestinal symptom management with over-the-counter medications, flushing symptom management with aspirin, and temporary dose reduction. Using the available evidence from clinical trials and evaluations of post-marketing studies, these strategies to manage gastrointestinal and flushing symptoms can be effective and helpful to the patient when initiating delayed-release dimethyl fumarate.

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Acknowledgements

Biogen provided funding for medical writing support in the development of this paper; Karen Spach from Excel Scientific Solutions wrote the first draft of the manuscript based on input from authors, and Kristen DeYoung from Excel Scientific Solutions copyedited and styled the manuscript per journal requirements. Biogen reviewed and provided feedback on the paper to the authors. The authors had full editorial control of the paper, and provided their final approval of all content.

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Authors and Affiliations

  1. Central Texas Neurology Consultants, Round Rock, TX, USA

    Lori Mayer

  2. The MS Center of St. Louis, St. Louis, MO, USA

    Mary Kay Fink

  3. NYU Langone MS Comprehensive Care Center, New York, NY, USA

    Carrie Sammarco & Lisa Laing

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All authors have agreed on the final version and meet the following ICMJE-recommended criteria (http://www.icmje.org/recommendations/): substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data, and revising the article critically for important intellectual content.

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Correspondence to Lori Mayer.

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Funding

Funding was provided by Biogen.

Conflicts of interest

Lori Mayer: Has received consulting fees from Biogen, EMD Serono, Genentech, Novartis Pharmaceuticals, Sanofi-Genzyme, and Teva Neuroscience. Mary Kay Fink: Has served as a speaker or advisor or on speaker bureaus for Acorda, Biogen, EMD Serono, Genentech, Genzme, Novartis Pharmaceuticals, and Teva; current employee of EMD Serono. Carrie Sammarco: Employer received grant to support nursing research for DMF side effect management, participated on an advisory board for Biogen, and received peer-to-peer fees. Lisa Laing: Employer received grant to support nursing research for DMF side effect management, participated on advisory board for Biogen, and received peer-to-peer fees.

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Mary Kay Fink is currently an employee of EMD Serono, Inc., Rockland, MA, but the majority of the work was conducted while she was with the MS Center of St. Louis.

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Mayer, L., Fink, M.K., Sammarco, C. et al. Management Strategies to Facilitate Optimal Outcomes for Patients Treated with Delayed-release Dimethyl Fumarate. Drug Saf 41, 347–356 (2018). https://doi.org/10.1007/s40264-017-0621-3

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