RESUMEN
BACKGROUND: Delayed-release dimethyl fumarate (DMF; also known as gastroresistant DMF) is indicated for the treatment of relapsing multiple sclerosis. Flushing and gastrointestinal (GI) adverse events (AEs) are common within the first few months of starting DMF therapy. Although most symptoms are mild or moderate in severity, transient, and infrequently result in treatment discontinuation, they nevertheless present a challenge for patients to adhere to therapy and achieve an optimal treatment response. METHODS: This review discusses management strategies for the prophylaxis and treatment of common DMF-associated AEs based on clinical trial evidence and real-world experience in clinical practice settings. RESULTS: Before starting DMF therapy, patients should receive counseling on the importance of treatment adherence and the likely occurrence and severity of flushing and GI AEs (nausea, vomiting, diarrhea, and abdominal pain). Management strategies, such as administering DMF with food, using a slower-dose titration schedule, applying temporary dose reductions, and using symptomatic therapies, provide clinicians with several approaches to address DMF tolerability. In particular, DMF coadministration with certain foods (eg, sausage, peanut butter) may prevent or reduce the severity of GI AEs. Taking aspirin 325 mg/day 30 minutes before administering DMF in the first month of therapy can reduce the incidence and severity of flushing without negatively affecting GI-related events. CONCLUSIONS: Through continual patient education and support and management of treatment-related flushing and GI AEs, clinicians can help patients adhere to and persist with DMF therapy, thus maximizing treatment benefit.
RESUMEN
BACKGROUND: Multiple sclerosis (MS) can adversely affect gait, causing gait slowing, loss of balance, decreased functional mobility, and gait deficits, such as footdrop. Current treatments for gait dysfunction due to MS are pharmacologic, using dalfampridine, or orthotic, using an ankle-foot orthosis. Functional electrical stimulation (FES) to the fibular nerve stimulates active dorsiflexion and provides an alternative treatment for gait dysfunction caused by footdrop. The objective of this study was to determine the effect of FES on gait function and the impact of MS on walking and quality of life for people with MS taking a stable dalfampridine dose. METHODS: Participants demonstrating gait slowing and footdrop completed the Timed 25-Foot Walk (T25FW) test, 6-Minute Walk (6MW) test, GaitRite Functional Ambulation Profile, 12-item Multiple Sclerosis Walking Scale (MSWS-12), and 36-item Short Form Health Status Survey (SF-36) at screening without FES; the measures were repeated with FES at baseline, 1 month, and 3 months. RESULTS: Twenty participants (8 men and 12 women) completed this unblinded case series study. The mean age, duration of MS, and time taking dalfampridine were 51.7, 15.8, and 1.4 years, respectively. Changes from screening to baseline and screening to 3 months were analyzed. Significant improvement was noted from screening to baseline for the MSWS-12 (P = .024) and SF-36 Physical Function domain (P = .028) and from screening to 3 months for the T25FW (P = .015), MSWS-12 (P = .003), and SF-36 Physical Function (P = .032) and Role Limitation-Physical Health (P = .012) domains. CONCLUSIONS: Improvements above those induced pharmacologically suggest that FES can augment pharmacologic intervention and significantly improve gait function, decrease the impact of MS on walking, and improve quality of life for people with MS.
RESUMEN
INTRODUCTION: Delayed-release dimethyl fumarate (DMF, also known as gastro-resistant DMF) is indicated for the treatment of patients with relapsing multiple sclerosis. Gastrointestinal (GI) adverse events (AEs) occur with DMF therapy. METHODS: We used a Delphi process to reach consensus among North American clinicians on effective real-world management strategies for GI AEs associated with DMF. Clinicians were asked to complete two rounds of questionnaires developed by a steering committee; consensus in round 2 was attained if ≥70% of respondents agreed on a particular strategy. RESULTS: Consensus was reached on several strategies to manage GI AEs, including administering DMF with food, slow titration, dose reduction, and use of symptomatic therapies. CONCLUSION: These consensus strategies provide clinicians with information on real-world approaches used to address the tolerability of DMF in patients with multiple sclerosis. FUNDING: Biogen.