Assessing Barriers to Adherence with the Use of Dimethyl Fumarate in Multiple Sclerosis
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Multiple sclerosis (MS) is a chronic, inflammatory, central nervous system demyelinating disease that requires long-term use of disease-modifying therapies (DMT). Patient adherence to DMT is key in reducing the inflammation that leads to relapses and neurodegeneration. Dimethyl fumarate (DMF) poses unique challenges to adherence including being the only twice-daily dosing DMT. Previous research suggests there are direct roles that providers play on improving their patients’ adherence rates, such as focusing on the patient-provider relationship, helping put the patient at ease so that they feel understood and respected. Also, route of administration affects adherence in other chronic healthcare conditions. However, the issue of adherence to DMT in MS is more complex than just route of administration, with adverse effects being the main predictor of adherence.
(1) To define various patient specific factors (e.g. fatigue and mood disorders) that affect adherence with DMF and (2) to understand how patients’ perceptions of treatment satisfaction (such as effectiveness, convenience, side effects and global satisfaction) and DMFs impact on quality of life (such as social support, activities of daily living, coping) influence adherence.
Our study was a prospective, observational measurement of adherence to treatment with DMF in MS patients over 52 weeks. Twenty-five out of thirty-five patients enrolled completed the study. Adverse event (AE) data was reviewed on all participants.
Adherence rates correlated with patient’s perceived effectiveness (0.25, p < 0.023) and the level of bothersome symptoms the patient experienced (0.45, p < 0.0001). The majority of new AE onset was reported within 12 weeks of DMF initiation. This is consistent with previously published data with DMF use.
Adherence rates are an important factor to be considered when starting patients on DMT. DMF creates its own barriers to adherence with our study highlighting some, including twice-daily dosing and AEs experienced following treatment initiation. Healthcare providers should be aware of these barriers prior to treatment initiation and counsel patients appropriately.
AA, DR, LC, and LP conceived and developed the protocol. LP performed the visits and data collection. AA performed the data analysis. DR, LC, JM, NM, AA, and CD contributed to the interpretation of the results. CD took the lead on writing the manuscript. DR completed final revisions and supervised the project. All authors discussed the results and commented on the manuscript.
Compliance with Ethical Standards
This research was funded by a grant from Biogen. This research was approved by the University of South Florida Institutional Review Board.
Conflict of Interest
Derrick Robertson is a consultant for Alexion, Biogen, Celgene, EMD Serono, Genentech, Novartis, Sanofi-Genzyme, and Teva Neuroscience; is on a speaker bureau for Acorda, Alexion, Biogen, Celgene, EMD Serono, Genentech, Mallinckrodt, Novartis, Sanofi-Genzyme, and Teva Neuroscience; and has received grant support from Actelion, Biogen, EMD Serono, Genentech, Medimmune, Mallinckrodt, MedDay, Novartis, PCORI, Sanofi-Genzyme, and TG Therapeutics. Lise Casady is on a speaker bureau and consults for Genentech, Sanofi-Genzyme, and Biogen. Janice Maldonado has received grant support from Genentech and Medimmune. Natalie Moreo, Crystal Dixon, Laurie Pearsall, and Angela Aungst have no conflicts of interest that are directly relevant to the content of this article.
All procedures in this study were in accordance with the 1964 Helsinki Declaration including amendments and with the oversight of the University of South Florida Institutional Review Board that approved the study.
Written informed consent was obtained from all patients who participated in this study.
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