title: Assessing the long-term clinical benefit of prolonged-release fampridine tablets in a real-world setting: a review of 67 cases.
abstract: OBJECTIVE
  To assess the long-term effects of prolonged-release (PR) fampridine tablets (dalfampridine extended release) in clinical practice in patients with multiple sclerosis (MS) with walking impairment.
  
  
  METHODS
  MS patients with walking impairment deemed candidates for treatment with PR-fampridine tablets were included in this case series. Clinical assessments included the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 12-item Multiple Sclerosis Walking Scale (MSWS-12), EuroQoL-5D, and the Fatigue Severity Scale (FSS). The T25FW was videotaped at each visit. Assessments were performed at baseline and after 4 weeks of treatment with PR-fampridine tablets 10 mg twice daily. Clinical benefit of treatment was defined as any improvement in T25FW or MSWS-12 score at 4 weeks. Patients who demonstrated clinical benefit continued treatment and were assessed at 3 and 6 months.
  
  
  RESULTS
  Among all patients (N = 67; mean MS duration, 16.5 years; mean EDSS score, 4.8; mean T25FW, 13.9 seconds), 65, 52, and 48 completed the 4-week, 3-month, and 6-month visits, respectively. After 4 weeks, 50.7% and 32.8% of patients walked ≥10% and ≥20% faster, respectively; and in 65.7% of patients, MSWS-12 scores improved. Three patients experienced adverse events (nausea, n = 2, insomnia, n = 1) that resulted in discontinuation of treatment. After 6 months, 38.8% and 16.4% of patients walked ≥10% and ≥20% faster versus baseline, respectively; and in 59.7% of patients, MSWS-12 scores improved. Among patients who demonstrated clinical benefit of treatment at 6 months, FSS scores improved on average by 1 point and MSWS-12 scores by 10 points. Three case studies showing different outcomes of PR-fampridine treatment are detailed with a visual depiction of the changes observed.
  
  
  CONCLUSIONS
  In this case series, a proportion of patients demonstrated a clinical benefit of PR-fampridine treatment on walking. Determining which patients derive benefit from PR-fampridine is an important aspect of treatment. A range of clinical and patient-reported factors should be considered when assessing the clinical benefit of PR-fampridine treatment in MS patients.
authors.affiliation: Neuroimmunology and Multiple Sclerosis Clinic and Research Unit, Clinical Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.
authors.forename: Michael
authors.initials: M
authors.lastname: Prugger
authors.forename: Thomas
authors.initials: T
authors.lastname: Berger
keywords: multiple sclerosis; treatment; video; walking