The EDSS-Plus, an improved endpoint for disability progression in secondary progressive multiple sclerosis

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

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The EDSS-Plus, an improved endpoint for disability progression in secondary progressive multiple sclerosis. / Cadavid, Diego; Cohen, Jeffrey A.; Freedman, Mark S.; Goldman, Myla D.; Hartung, Hans Peter; Havrdova, Eva; Jeffery, Douglas; Kapoor, Raj; Miller, Aaron; Sellebjerg, Finn; Kinch, Deborah; Lee, Sophia; Shang, Shulian; Mikol, Daniel.

I: Multiple Sclerosis, Bind 23, Nr. 1, 2017, s. 94-105.

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

Harvard

Cadavid, D, Cohen, JA, Freedman, MS, Goldman, MD, Hartung, HP, Havrdova, E, Jeffery, D, Kapoor, R, Miller, A, Sellebjerg, F, Kinch, D, Lee, S, Shang, S & Mikol, D 2017, 'The EDSS-Plus, an improved endpoint for disability progression in secondary progressive multiple sclerosis', Multiple Sclerosis, bind 23, nr. 1, s. 94-105. https://doi.org/10.1177/1352458516638941

APA

Cadavid, D., Cohen, J. A., Freedman, M. S., Goldman, M. D., Hartung, H. P., Havrdova, E., Jeffery, D., Kapoor, R., Miller, A., Sellebjerg, F., Kinch, D., Lee, S., Shang, S., & Mikol, D. (2017). The EDSS-Plus, an improved endpoint for disability progression in secondary progressive multiple sclerosis. Multiple Sclerosis, 23(1), 94-105. https://doi.org/10.1177/1352458516638941

Vancouver

Cadavid D, Cohen JA, Freedman MS, Goldman MD, Hartung HP, Havrdova E o.a. The EDSS-Plus, an improved endpoint for disability progression in secondary progressive multiple sclerosis. Multiple Sclerosis. 2017;23(1):94-105. https://doi.org/10.1177/1352458516638941

Author

Cadavid, Diego ; Cohen, Jeffrey A. ; Freedman, Mark S. ; Goldman, Myla D. ; Hartung, Hans Peter ; Havrdova, Eva ; Jeffery, Douglas ; Kapoor, Raj ; Miller, Aaron ; Sellebjerg, Finn ; Kinch, Deborah ; Lee, Sophia ; Shang, Shulian ; Mikol, Daniel. / The EDSS-Plus, an improved endpoint for disability progression in secondary progressive multiple sclerosis. I: Multiple Sclerosis. 2017 ; Bind 23, Nr. 1. s. 94-105.

Bibtex

@article{eb4aba25549748bfa9e0437881821eec,
title = "The EDSS-Plus, an improved endpoint for disability progression in secondary progressive multiple sclerosis",
abstract = "Background: The Expanded Disability Status Scale (EDSS) has wide scientific and regulatory precedent but limited ability to detect clinically relevant disability progression in secondary progressive multiple sclerosis (SPMS) patients, partly due to a lack of meaningful measurement of short-distance ambulatory and upper-extremity function. Objective: To present a rationale for a composite endpoint adding the timed 25-foot walk (T25FW) and 9-Hole Peg Test (9HPT) to EDSS for SPMS disability progression assessment. Methods: Using the International Multiple Sclerosis Secondary Progressive Avonex Clinical Trial (IMPACT) placebo arm (n = 215) data, we analyzed disability progression using a novel progression endpoint, {"}EDSS-Plus,{"} defined as progression on ≥1 of 3 components (EDSS, T25FW, and/or 9HPT) confirmed ≥24 weeks apart and with a ≥20% minimum threshold change for T25FW and 9HPT. Results: Over 2 years, subjects classified as T25FW, 9HPT (dominant hand), or 9HPT (non-dominant hand) progressors worsened on average by 103.4%, 69.0%, and 59.2%, respectively, while non-progressors' times remained largely unchanged. Using EDSS-Plus, 59.5% of the patients had 24-week confirmed disability progression versus 24.7% (EDSS), 41.9% (T25FW), and 34.4% (9HPT (either hand)) on each component alone. Conclusion: The 24-week confirmed minimum worsening of ≥20% for T25FW and 9HPT clearly separates SPMS progressors from non-progressors. We propose that EDSS-Plus may represent an improved endpoint to identify SPMS disability progression.",
keywords = "Disability evaluation, disease progression, endpoint determination, secondary progressive multiple sclerosis",
author = "Diego Cadavid and Cohen, {Jeffrey A.} and Freedman, {Mark S.} and Goldman, {Myla D.} and Hartung, {Hans Peter} and Eva Havrdova and Douglas Jeffery and Raj Kapoor and Aaron Miller and Finn Sellebjerg and Deborah Kinch and Sophia Lee and Shulian Shang and Daniel Mikol",
year = "2017",
doi = "10.1177/1352458516638941",
language = "English",
volume = "23",
pages = "94--105",
journal = "Multiple Sclerosis Journal",
issn = "1352-4585",
publisher = "SAGE Publications",
number = "1",

}

RIS

TY - JOUR

T1 - The EDSS-Plus, an improved endpoint for disability progression in secondary progressive multiple sclerosis

AU - Cadavid, Diego

AU - Cohen, Jeffrey A.

AU - Freedman, Mark S.

AU - Goldman, Myla D.

AU - Hartung, Hans Peter

AU - Havrdova, Eva

AU - Jeffery, Douglas

AU - Kapoor, Raj

AU - Miller, Aaron

AU - Sellebjerg, Finn

AU - Kinch, Deborah

AU - Lee, Sophia

AU - Shang, Shulian

AU - Mikol, Daniel

PY - 2017

Y1 - 2017

N2 - Background: The Expanded Disability Status Scale (EDSS) has wide scientific and regulatory precedent but limited ability to detect clinically relevant disability progression in secondary progressive multiple sclerosis (SPMS) patients, partly due to a lack of meaningful measurement of short-distance ambulatory and upper-extremity function. Objective: To present a rationale for a composite endpoint adding the timed 25-foot walk (T25FW) and 9-Hole Peg Test (9HPT) to EDSS for SPMS disability progression assessment. Methods: Using the International Multiple Sclerosis Secondary Progressive Avonex Clinical Trial (IMPACT) placebo arm (n = 215) data, we analyzed disability progression using a novel progression endpoint, "EDSS-Plus," defined as progression on ≥1 of 3 components (EDSS, T25FW, and/or 9HPT) confirmed ≥24 weeks apart and with a ≥20% minimum threshold change for T25FW and 9HPT. Results: Over 2 years, subjects classified as T25FW, 9HPT (dominant hand), or 9HPT (non-dominant hand) progressors worsened on average by 103.4%, 69.0%, and 59.2%, respectively, while non-progressors' times remained largely unchanged. Using EDSS-Plus, 59.5% of the patients had 24-week confirmed disability progression versus 24.7% (EDSS), 41.9% (T25FW), and 34.4% (9HPT (either hand)) on each component alone. Conclusion: The 24-week confirmed minimum worsening of ≥20% for T25FW and 9HPT clearly separates SPMS progressors from non-progressors. We propose that EDSS-Plus may represent an improved endpoint to identify SPMS disability progression.

AB - Background: The Expanded Disability Status Scale (EDSS) has wide scientific and regulatory precedent but limited ability to detect clinically relevant disability progression in secondary progressive multiple sclerosis (SPMS) patients, partly due to a lack of meaningful measurement of short-distance ambulatory and upper-extremity function. Objective: To present a rationale for a composite endpoint adding the timed 25-foot walk (T25FW) and 9-Hole Peg Test (9HPT) to EDSS for SPMS disability progression assessment. Methods: Using the International Multiple Sclerosis Secondary Progressive Avonex Clinical Trial (IMPACT) placebo arm (n = 215) data, we analyzed disability progression using a novel progression endpoint, "EDSS-Plus," defined as progression on ≥1 of 3 components (EDSS, T25FW, and/or 9HPT) confirmed ≥24 weeks apart and with a ≥20% minimum threshold change for T25FW and 9HPT. Results: Over 2 years, subjects classified as T25FW, 9HPT (dominant hand), or 9HPT (non-dominant hand) progressors worsened on average by 103.4%, 69.0%, and 59.2%, respectively, while non-progressors' times remained largely unchanged. Using EDSS-Plus, 59.5% of the patients had 24-week confirmed disability progression versus 24.7% (EDSS), 41.9% (T25FW), and 34.4% (9HPT (either hand)) on each component alone. Conclusion: The 24-week confirmed minimum worsening of ≥20% for T25FW and 9HPT clearly separates SPMS progressors from non-progressors. We propose that EDSS-Plus may represent an improved endpoint to identify SPMS disability progression.

KW - Disability evaluation

KW - disease progression

KW - endpoint determination

KW - secondary progressive multiple sclerosis

U2 - 10.1177/1352458516638941

DO - 10.1177/1352458516638941

M3 - Journal article

C2 - 27003945

AN - SCOPUS:85011347312

VL - 23

SP - 94

EP - 105

JO - Multiple Sclerosis Journal

JF - Multiple Sclerosis Journal

SN - 1352-4585

IS - 1

ER -

ID: 196919008