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-...
Autores principales: | , , , , , , , , , , , , , |
---|---|
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 |