Richard Macdonell1, Guy Nagels2, David-Axel Laplaud3, Carlo Pozzilli4, Brigit de Jong5, Ana Martins da Silva6, Richard Nicholas7, Jeannette Lechner-Scott8, Julia A Gaebler9, Sonalee Agarwal9, Ping Wang9, Michael Yeh9, Maria Hovenden10, Per Soelberg Sørensen11. 1. Department of Neurology, Austin Health, University of Melbourne, Australia Richard.Macdonell@austin.org.au. 2. National Multiple Sclerosis Center Melsbroek and Center for Neurosciences, Vrije Universiteit Brussel, Belgium. 3. Centre Hospitalier Universitaire de Nantes, Hôpital G. et R. Laennec, France. 4. The Department of Neurology and Psychiatry, Sapienza University, Italy. 5. Radboud University Medical Center, Nijmegen and the Neurology Department of Jeroen Bosch Hospital, The Netherlands. 6. Neurosciences Department, Hospital Santo António-Centro Hospitalar do Porto, Portugal. 7. Imperial College, UK. 8. Hunter Medical Research Institute, The University of Newcastle, Australia. 9. Biogen, Cambridge, MA, USA. 10. Excel Scientific Solutions, Southport, CT, USA. 11. Danish Multiple Sclerosis Center, Copenhagen University Hospital Rigshospitalet, Denmark.
Abstract
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.
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.
Authors: Filipa Ladeira; Marcelo Mendonça; André Caetano; Manuel Salavisa; Henrique Delgado; Ana Sofia Correia; Miguel Viana-Baptista Journal: Neurol Sci Date: 2018-10-29 Impact factor: 3.307
Authors: Jeremy Hobart; Tjalf Ziemssen; Peter Feys; Michael Linnebank; Andrew D Goodman; Rachel Farrell; Raymond Hupperts; Andrew R Blight; Veronica Englishby; Manjit McNeill; Ih Chang; Gabriel Lima; Jacob Elkins Journal: CNS Drugs Date: 2019-01 Impact factor: 5.749