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Published on: June 30, 2014
Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine
Richard Macdonell1, Guy Nagels2, David-Axel Laplaud3
1Department of Neurology, Austin Health, University of Melbourne, Australia Richard.Macdonell@austin.org.au.
Background:
Multiple sclerosis (MS) is a debilitating disease that negatively impacts patients' lives.
Objective:
ENABLE assessed the effect of long-term prolonged-release (PR) fampridine (dalfampridine extended release in the United States) treatment on patient-perceived health impact in patients with MS with walking impairment.
Methods:
ENABLE was a 48-week, open-label, Phase 4 study of PR-fampridine 10 mg twice daily. Patients who showed any improvement in Timed 25-Foot Walk walking speed at weeks 2 and 4 and any improvement in 12-item MS Walking Scale score at week 4 remained on treatment. The primary endpoint was change from baseline in 36-Item Short-Form Health Survey (SF-36) physical component summary (PCS) score.
Results:
At week 4, 707/901 (78.5%) patients met the criteria to remain on treatment. Patients on treatment demonstrated significant and clinically meaningful improvements in SF-36 PCS scores from baseline (mean change (95% confidence interval)) to week 12 (4.30 (3.83, 4.78); p < 0.0001), week 24 (3.75 (3.23, 4.27); p < 0.0001), week 36 (3.46 (2.95, 3.97); p < 0.0001), and week 48 (3.24 (2.72, 3.77); p < 0.0001). Significant improvements from baseline were also demonstrated in secondary health measures in patients on treatment.
Conclusion:
PR-fampridine improved patient-perceived physical and psychological health impact of MS measured in a real-life setting.
