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 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 Lechner-Scott, Julia A Gaebler, Sonalee Agarwal, Ping Wang, Michael Yeh, Maria Hovenden, Per Soelberg Sørensen

Afdeling for Hjerne- og Nervesygdomme

21 Citationer (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.

Originalsprog	Engelsk
Tidsskrift	Multiple sclerosis
Vol/bind	22
Udgave nummer	7
Sider (fra-til)	944-54
Antal sider	11
ISSN	1352-4585
DOI	https://doi.org/10.1177/1352458515606809
Status	Udgivet - jun. 2016

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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., 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), 944-54. 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, J, 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, bind 22, nr. 7, s. 944-54. https://doi.org/10.1177/1352458515606809

@article{4878a16328714771b4d5cf8a5b244711,

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.",

keywords = "Journal Article",

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 Jeannette Lechner-Scott and Gaebler, {Julia A} and Sonalee Agarwal and Ping Wang and Michael Yeh and Maria Hovenden and {Soelberg S{\o}rensen}, Per",

note = "{\textcopyright} The Author(s), 2015.",

year = "2016",

month = jun,

doi = "10.1177/1352458515606809",

language = "English",

volume = "22",

pages = "944--54",

journal = "Multiple sclerosis",

issn = "1352-4585",

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TY - JOUR

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

AU - Gaebler, Julia A

AU - Agarwal, Sonalee

AU - Wang, Ping

AU - Yeh, Michael

AU - Hovenden, Maria

AU - Soelberg Sørensen, Per

PY - 2016/6

Y1 - 2016/6

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.

KW - Journal Article

U2 - 10.1177/1352458515606809

DO - 10.1177/1352458515606809

M3 - Journal article

C2 - 26447066

SN - 1352-4585

VL - 22

SP - 944

EP - 954

JO - Multiple sclerosis

JF - Multiple sclerosis

IS - 7

ER -

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

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