Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine

Richard Macdonell; Guy Nagels; David-Axel Laplaud; Carlo Pozzilli; Brigit de Jong; Ana Martins da Silva; Richard Nicholas; Jeannette S Lechner-Scott; Julia A Gaebler; Sonalee Agarwal; Ping Wang; Michael Yeh; Maria Hovenden; Per Soelberg Sørensen

doi:10.1177/1352458515606809

Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine

Richard Macdonell, Guy Nagels, David-Axel Laplaud, Carlo Pozzilli, Brigit de Jong, Ana Martins da Silva, Richard Nicholas, Jeannette S Lechner-Scott, Julia A Gaebler, Sonalee Agarwal, Ping Wang, Michael Yeh, Maria Hovenden, Per Soelberg Sørensen

Department of Clinical Medicine

16 Citations (Scopus)

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.

Original language	English
Journal	Multiple Sclerosis
Volume	22
Issue number	7
Pages (from-to)	944-954
Number of pages	11
ISSN	1352-4585
DOIs	https://doi.org/10.1177/1352458515606809
Publication status	Published - 1 Jun 2016

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Journal Article

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10.1177/1352458515606809

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Macdonell, R., Nagels, G., Laplaud, D-A., Pozzilli, C., de Jong, B., Martins da Silva, A., Nicholas, R., Lechner-Scott, J. S., Gaebler, J. A., Agarwal, S., Wang, P., Yeh, M., Hovenden, M., & Soelberg Sørensen, P. (2016). Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine. Multiple Sclerosis, 22(7), 944-954. https://doi.org/10.1177/1352458515606809

Macdonell, R, Nagels, G, Laplaud, D-A, Pozzilli, C, de Jong, B, Martins da Silva, A, Nicholas, R, Lechner-Scott, JS, Gaebler, JA, Agarwal, S, Wang, P, Yeh, M, Hovenden, M & Soelberg Sørensen, P 2016, 'Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine', Multiple Sclerosis, vol. 22, no. 7, pp. 944-954. https://doi.org/10.1177/1352458515606809

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title = "Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine",

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.",

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author = "Richard Macdonell and Guy Nagels and David-Axel Laplaud and Carlo Pozzilli and {de Jong}, Brigit and {Martins da Silva}, Ana and Richard Nicholas and Lechner-Scott, {Jeannette S} and Gaebler, {Julia A} and Sonalee Agarwal and Ping Wang and Michael Yeh and Maria Hovenden and {Soelberg S{\o}rensen}, Per",

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year = "2016",

month = jun,

day = "1",

doi = "10.1177/1352458515606809",

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T1 - Improved patient-reported health impact of multiple sclerosis

T2 - The ENABLE study of PR-fampridine

AU - Macdonell, Richard

AU - Nagels, Guy

AU - Laplaud, David-Axel

AU - Pozzilli, Carlo

AU - de Jong, Brigit

AU - Martins da Silva, Ana

AU - Nicholas, Richard

AU - Lechner-Scott, Jeannette S

AU - Gaebler, Julia A

AU - Agarwal, Sonalee

AU - Wang, Ping

AU - Yeh, Michael

AU - Hovenden, Maria

AU - Soelberg Sørensen, Per

PY - 2016/6/1

Y1 - 2016/6/1

N2 - 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.

AB - 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.

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DO - 10.1177/1352458515606809

M3 - Journal article

C2 - 26447066

SN - 1352-4585

VL - 22

SP - 944

EP - 954

JO - Multiple Sclerosis Journal

JF - Multiple Sclerosis Journal

IS - 7

ER -

Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine

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