Cargando…

Early versus delayed treatment with glatiramer acetate: Analysis of up to 27 years of continuous follow-up in a US open-label extension study

BACKGROUND: Glatiramer acetate (GA) is US-approved for relapsing multiple sclerosis. OBJECTIVES: To describe GA long-term clinical profile. To compare effectiveness of early start (ES) versus delayed start (DS; up to 3 years) with GA. METHODS: Phase 3 trial participants entered a randomized placebo-...

Descripción completa

Detalles Bibliográficos
Autores principales: Ford, Corey C, Cohen, Jeffrey A, Goodman, Andrew D, Lindsey, John W, Lisak, Robert P, Luzzio, Christopher, Pruitt, Amy, Rose, John, Rus, Horea, Wolinsky, Jerry S, Kadosh, Shaul E, Bernstein-Hanlon, Emily, Stark, Yafit, Alexander, Jessica K
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9442630/
https://www.ncbi.nlm.nih.gov/pubmed/35768939
http://dx.doi.org/10.1177/13524585221094239
_version_ 1784782858304356352
author Ford, Corey C
Cohen, Jeffrey A
Goodman, Andrew D
Lindsey, John W
Lisak, Robert P
Luzzio, Christopher
Pruitt, Amy
Rose, John
Rus, Horea
Wolinsky, Jerry S
Kadosh, Shaul E
Bernstein-Hanlon, Emily
Stark, Yafit
Alexander, Jessica K
author_facet Ford, Corey C
Cohen, Jeffrey A
Goodman, Andrew D
Lindsey, John W
Lisak, Robert P
Luzzio, Christopher
Pruitt, Amy
Rose, John
Rus, Horea
Wolinsky, Jerry S
Kadosh, Shaul E
Bernstein-Hanlon, Emily
Stark, Yafit
Alexander, Jessica K
author_sort Ford, Corey C
collection PubMed
description BACKGROUND: Glatiramer acetate (GA) is US-approved for relapsing multiple sclerosis. OBJECTIVES: To describe GA long-term clinical profile. To compare effectiveness of early start (ES) versus delayed start (DS; up to 3 years) with GA. METHODS: Phase 3 trial participants entered a randomized placebo-controlled period then an open-label extension (OLE) with GA. RESULTS: Overall, 208 out of 251 (82.9%) randomized participants entered the OLE; 24 out of 101 (23.8%, ES) and 28 out of 107 (26.2%, DS) participants completed the OLE. Median GA treatment was 9.8 (0.1–26.3) years. Annualized change in Expanded Disability Status Scale (EDSS) score was lower with ES versus DS (p = 0.0858: full study; p = 0.002; Year 5). Participants with improved/stable EDSS was consistently higher with ES versus DS: 40.3% versus 31.6% (p = 0.1590; full study); 70.8% versus 55.6% (p = 0.015; Year 5). ES prolonged time-to-6-month confirmed disease worsening (CDW) versus DS (9.8 vs 6.7 years), time-to-12-month CDW (18.9 vs 11.6 years), and significantly reduced time-to-second-6-month CDW (p = 0.0441). No new safety concerns arose. CONCLUSION: GA long-term treatment maintained clinical benefit with a similar safety profile to phase 3 results; a key limitation was that only 25% of participants completed the OLE. Early initiation of GA had sustained benefits versus delayed treatment.
format Online
Article
Text
id pubmed-9442630
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher SAGE Publications
record_format MEDLINE/PubMed
spelling pubmed-94426302022-09-06 Early versus delayed treatment with glatiramer acetate: Analysis of up to 27 years of continuous follow-up in a US open-label extension study Ford, Corey C Cohen, Jeffrey A Goodman, Andrew D Lindsey, John W Lisak, Robert P Luzzio, Christopher Pruitt, Amy Rose, John Rus, Horea Wolinsky, Jerry S Kadosh, Shaul E Bernstein-Hanlon, Emily Stark, Yafit Alexander, Jessica K Mult Scler Original Research Papers BACKGROUND: Glatiramer acetate (GA) is US-approved for relapsing multiple sclerosis. OBJECTIVES: To describe GA long-term clinical profile. To compare effectiveness of early start (ES) versus delayed start (DS; up to 3 years) with GA. METHODS: Phase 3 trial participants entered a randomized placebo-controlled period then an open-label extension (OLE) with GA. RESULTS: Overall, 208 out of 251 (82.9%) randomized participants entered the OLE; 24 out of 101 (23.8%, ES) and 28 out of 107 (26.2%, DS) participants completed the OLE. Median GA treatment was 9.8 (0.1–26.3) years. Annualized change in Expanded Disability Status Scale (EDSS) score was lower with ES versus DS (p = 0.0858: full study; p = 0.002; Year 5). Participants with improved/stable EDSS was consistently higher with ES versus DS: 40.3% versus 31.6% (p = 0.1590; full study); 70.8% versus 55.6% (p = 0.015; Year 5). ES prolonged time-to-6-month confirmed disease worsening (CDW) versus DS (9.8 vs 6.7 years), time-to-12-month CDW (18.9 vs 11.6 years), and significantly reduced time-to-second-6-month CDW (p = 0.0441). No new safety concerns arose. CONCLUSION: GA long-term treatment maintained clinical benefit with a similar safety profile to phase 3 results; a key limitation was that only 25% of participants completed the OLE. Early initiation of GA had sustained benefits versus delayed treatment. SAGE Publications 2022-06-29 2022-10 /pmc/articles/PMC9442630/ /pubmed/35768939 http://dx.doi.org/10.1177/13524585221094239 Text en © The Author(s), 2022 https://creativecommons.org/licenses/by/4.0/This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Research Papers
Ford, Corey C
Cohen, Jeffrey A
Goodman, Andrew D
Lindsey, John W
Lisak, Robert P
Luzzio, Christopher
Pruitt, Amy
Rose, John
Rus, Horea
Wolinsky, Jerry S
Kadosh, Shaul E
Bernstein-Hanlon, Emily
Stark, Yafit
Alexander, Jessica K
Early versus delayed treatment with glatiramer acetate: Analysis of up to 27 years of continuous follow-up in a US open-label extension study
title Early versus delayed treatment with glatiramer acetate: Analysis of up to 27 years of continuous follow-up in a US open-label extension study
title_full Early versus delayed treatment with glatiramer acetate: Analysis of up to 27 years of continuous follow-up in a US open-label extension study
title_fullStr Early versus delayed treatment with glatiramer acetate: Analysis of up to 27 years of continuous follow-up in a US open-label extension study
title_full_unstemmed Early versus delayed treatment with glatiramer acetate: Analysis of up to 27 years of continuous follow-up in a US open-label extension study
title_short Early versus delayed treatment with glatiramer acetate: Analysis of up to 27 years of continuous follow-up in a US open-label extension study
title_sort early versus delayed treatment with glatiramer acetate: analysis of up to 27 years of continuous follow-up in a us open-label extension study
topic Original Research Papers
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9442630/
https://www.ncbi.nlm.nih.gov/pubmed/35768939
http://dx.doi.org/10.1177/13524585221094239
work_keys_str_mv AT fordcoreyc earlyversusdelayedtreatmentwithglatirameracetateanalysisofupto27yearsofcontinuousfollowupinausopenlabelextensionstudy
AT cohenjeffreya earlyversusdelayedtreatmentwithglatirameracetateanalysisofupto27yearsofcontinuousfollowupinausopenlabelextensionstudy
AT goodmanandrewd earlyversusdelayedtreatmentwithglatirameracetateanalysisofupto27yearsofcontinuousfollowupinausopenlabelextensionstudy
AT lindseyjohnw earlyversusdelayedtreatmentwithglatirameracetateanalysisofupto27yearsofcontinuousfollowupinausopenlabelextensionstudy
AT lisakrobertp earlyversusdelayedtreatmentwithglatirameracetateanalysisofupto27yearsofcontinuousfollowupinausopenlabelextensionstudy
AT luzziochristopher earlyversusdelayedtreatmentwithglatirameracetateanalysisofupto27yearsofcontinuousfollowupinausopenlabelextensionstudy
AT pruittamy earlyversusdelayedtreatmentwithglatirameracetateanalysisofupto27yearsofcontinuousfollowupinausopenlabelextensionstudy
AT rosejohn earlyversusdelayedtreatmentwithglatirameracetateanalysisofupto27yearsofcontinuousfollowupinausopenlabelextensionstudy
AT rushorea earlyversusdelayedtreatmentwithglatirameracetateanalysisofupto27yearsofcontinuousfollowupinausopenlabelextensionstudy
AT wolinskyjerrys earlyversusdelayedtreatmentwithglatirameracetateanalysisofupto27yearsofcontinuousfollowupinausopenlabelextensionstudy
AT kadoshshaule earlyversusdelayedtreatmentwithglatirameracetateanalysisofupto27yearsofcontinuousfollowupinausopenlabelextensionstudy
AT bernsteinhanlonemily earlyversusdelayedtreatmentwithglatirameracetateanalysisofupto27yearsofcontinuousfollowupinausopenlabelextensionstudy
AT starkyafit earlyversusdelayedtreatmentwithglatirameracetateanalysisofupto27yearsofcontinuousfollowupinausopenlabelextensionstudy
AT alexanderjessicak earlyversusdelayedtreatmentwithglatirameracetateanalysisofupto27yearsofcontinuousfollowupinausopenlabelextensionstudy