Dimethyl fumarate (DMF) is a commonly prescribed oral medication for the treatment of relapsing forms of multiple sclerosis (MS) with a wide range of hypothesized downstream mechanisms of action. Randomized clinical trials have established its clinical efficacy by using standard objective clinical measures. However, MS is a chronic disease that, apart from physical ailments, can affect an individual's mood, psychosocial status, and quality of life which cannot be captured by using only objective assessment tools. Given the challenge of determining the efficacy of the treatment in a real-world clinical setting, the use of patient-reported outcomes (PROs) may help us to better address these aspects of patient care and establish a more patient-centered approach to MS care. To date, a review of PubMed identified six studies which reported on PROs in patients who are taking DMF. In total, twelve different kinds of PRO measures were utilized and 6359 patients provided at least one form of PRO in these studies. Upon review of these studies, we were able to conclude that people with MS had decreased quality of life compared to the healthy population in the US. MS patients on DMF, however, had better health-related quality of life assessment scores compared to those using a placebo. Previous studies also suggested that DMF decreased work productivity impairment scores after one year of use compared to baseline. DMF was associated with less impairment in fatigue and depression scales along with improved treatment quality assessment and adherence scores. This review will present a brief synopsis of the published literature and will provide indications for future directions with respect to PROs and DMF in people with MS.
Keywords: dimethyl fumarate; multiple sclerosis; outcome measures; patient-reported outcomes; quality of life.
© 2019 Ozel et al.
Conflict of interest statement
CV reports grants from Biogen, during the conduct of the study; personal fees from Merck/EMD Serono, outside the submitted work. BWG has received personal compensation (grants and/or personal fees) from Biogen Idec, Teva Neuroscience, EMD Serono, Novartis, Genzyme, Sanofi, Celgene and Genentech for speaking and consultant fees, and personal fees from Abbvie, outside the submitted work; they also participated in advisory boards for and have received research support from Biogen Idec, EMD Serono, Novartis, Genentech, Mallinckrodt Pharmaceuticals and Celgene. The authors report no other conflicts of interest in this work.
Effects of Delayed-Release Dimethyl Fumarate (DMF) on Health-Related Quality of Life in Patients With Relapsing-Remitting Multiple Sclerosis: An Integrated Analysis of the Phase 3 DEFINE and CONFIRM StudiesM Kita et al. Clin Ther 36 (12), 1958-1971. PMID 25315404. - Randomized Controlled TrialThese HRQoL benefits parallel the improvements in clinical and magnetic resonance imaging end points with delayed-release DMF, suggesting that delayed-release DMF treatme …
Effectiveness of Delayed-Release Dimethyl Fumarate on Patient-Reported Outcomes and Clinical Measures in Patients With Relapsing-Remitting Multiple Sclerosis in a Real-World Clinical Setting: PROTECT Berger et al. Mult Scler J Exp Transl Clin 5 (4), 2055217319887191. PMID 31832225.At 12 months after versus 12 months before DMF initiation, ARR was significantly lower, the majority of patients were relapse-free, and multiple PRO measures showed impro …
Effectiveness of Delayed-release Dimethyl Fumarate on Clinical and Patient-reported Outcomes in Patients With Relapsing Multiple Sclerosis Switching From Glatiramer Acetate: RESPOND, a Prospective Observational StudyK Kresa-Reahl et al. Clin Ther 40 (12), 2077-2087. PMID 30470580.DMF may be an effective treatment option in patients with RMS who experience a suboptimal response to GA. The results should be interpreted with caution due to the observ …
Design of Oral Agents for the Management of Multiple Sclerosis: Benefit and Risk Assessment for Dimethyl FumarateJA Nicholas et al. Drug Des Devel Ther 8, 897-908. PMID 25045248. - ReviewDimethyl fumarate (DMF) is the most recent oral disease-modifying therapy approved by the US Food and Drug Administration and is indicated for the treatment of relapsing …
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