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

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Improved patient-reported health impact of multiple sclerosis : The ENABLE study of PR-fampridine. / Macdonell, Richard; Nagels, Guy; Laplaud, David-Axel; Pozzilli, Carlo; de Jong, Brigit; Martins da Silva, Ana; Nicholas, Richard; Lechner-Scott, Jeannette S; Gaebler, Julia A; Agarwal, Sonalee; Wang, Ping; Yeh, Michael; Hovenden, Maria; Soelberg Sørensen, Per.

I: Multiple Sclerosis, Bind 22, Nr. 7, 06.2016, s. 944-954.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Harvard

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, bind 22, nr. 7, s. 944-954. https://doi.org/10.1177/1352458515606809

APA

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

Vancouver

Macdonell R, Nagels G, Laplaud D-A, Pozzilli C, de Jong B, Martins da Silva A o.a. Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine. Multiple Sclerosis. 2016 jun.;22(7):944-954. https://doi.org/10.1177/1352458515606809

Author

Macdonell, Richard ; Nagels, Guy ; Laplaud, David-Axel ; Pozzilli, Carlo ; de Jong, Brigit ; Martins da Silva, Ana ; Nicholas, Richard ; Lechner-Scott, Jeannette S ; Gaebler, Julia A ; Agarwal, Sonalee ; Wang, Ping ; Yeh, Michael ; Hovenden, Maria ; Soelberg Sørensen, Per. / Improved patient-reported health impact of multiple sclerosis : The ENABLE study of PR-fampridine. I: Multiple Sclerosis. 2016 ; Bind 22, Nr. 7. s. 944-954.

Bibtex

@article{34cd159e80924409814adc89d755d02e,
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 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",
note = "{\textcopyright} The Author(s), 2015.",
year = "2016",
month = jun,
doi = "10.1177/1352458515606809",
language = "English",
volume = "22",
pages = "944--954",
journal = "Multiple Sclerosis Journal",
issn = "1352-4585",
publisher = "SAGE Publications",
number = "7",

}

RIS

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 S

AU - Gaebler, Julia A

AU - Agarwal, Sonalee

AU - Wang, Ping

AU - Yeh, Michael

AU - Hovenden, Maria

AU - Soelberg Sørensen, Per

N1 - © The Author(s), 2015.

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

VL - 22

SP - 944

EP - 954

JO - Multiple Sclerosis Journal

JF - Multiple Sclerosis Journal

SN - 1352-4585

IS - 7

ER -

ID: 179879341