Abstract

Prolonged-release (PR) fampridine (dalfampridine extended release in the United States) is approved for the improvement of walking in adult patients with multiple sclerosis (MS). It has been suggested that PR-fampridine could be associated with beneficial effects beyond walking. We investigated if an improvement in fatigue could be detected in patients who received PR-fampridine, among participants in a cross-sectional study of people with MS (PwMS) from 16 countries in Europe. Fatigue scores on a 10 point visual analogue scale (VAS) in PwMS and Expanded Disability Status Scale (EDSS) 4-7 from the study were analysed. A multiple regression analysis assessed the impact of PR-fampridine on fatigue improvement, with adjustment for categorical variables (gender, current treatment, relapse during last month, physical therapy use, and country) and continuously distributed variables such as disease duration, age, and EDSS. Two-tailed Student’s t-tests were used to test for differences in fatigue scores. In total, 934 patients on PR-fampridine and 4,171 who were not receiving PR-fampridine were analysed. The on-PR-fampridine group was slightly younger than the off-PR-fampridine group (mean age 53.3 vs 54.5 years; p=0.0024), had more male patients (20% vs 17%; p=0.0103), higher EDSS score (median EDSS 6 vs 5), and used more physical therapy (24% vs 14%; p<0.0001). The on-PR-fampridine group had lower fatigue score compared with the off-PR-fampridine group (mean value 5.54 vs 5.96; p<0.001). Adjusted multiple regression analysis demonstrated that PR-fampridine treatment was associated with significant fatigue score improvement – lowering fatigue score by 0.38 points on the VAS (p<0.0001). The effects of DMTs and age on fatigue score were not statistically significant. PwMS treated with PR-fampridine demonstrated a significantly lower fatigue score when compared to non-PR-fampridine patients in this cohort. Results from this study should be integrated with findings from other sources.

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