Cargando…

Sub-analysis of geographical variations in the 2-year observational COPTIMIZE trial of patients with relapsing–remitting multiple sclerosis converting to glatiramer acetate

BACKGROUND: Studies suggest that patients with relapsing–remitting multiple sclerosis (RRMS) who fail to benefit from a disease-modifying treatment (DMT) may benefit from converting to another DMT class. COPTIMIZE was a 24-month observational study designed to assess the disease course of patients c...

Descripción completa

Detalles Bibliográficos
Autores principales: Ziemssen, Tjalf, Gilgun-Sherki, Yossi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4599648/
https://www.ncbi.nlm.nih.gov/pubmed/26450155
http://dx.doi.org/10.1186/s12883-015-0448-4
_version_ 1782394293425537024
author Ziemssen, Tjalf
Gilgun-Sherki, Yossi
author_facet Ziemssen, Tjalf
Gilgun-Sherki, Yossi
author_sort Ziemssen, Tjalf
collection PubMed
description BACKGROUND: Studies suggest that patients with relapsing–remitting multiple sclerosis (RRMS) who fail to benefit from a disease-modifying treatment (DMT) may benefit from converting to another DMT class. COPTIMIZE was a 24-month observational study designed to assess the disease course of patients converting to glatiramer acetate (GA) 20 mg daily from another DMT and the association of disease characteristics and reasons for converting. This sub-analysis was to determine if any findings varied by three geographic locations: Latin America (LA), Canada and Western Europe (CWE), and Eastern Europe (EE). METHODS: A total of 668 patients were included (263 LA, 248 CWE, 157 EE) in an analysis of annualized relapse rate (ARR) and annualized rate of deterioration (ARD), as well as secondary endpoints including reason for DMT switch and changes in disability and fatigue scores. Repeated-measures analysis of variance and log transformation were used to analyze ARR and ARD, whereas the Wilcoxon signed rank test was used for secondary endpoints. RESULTS: The sub-analysis of treatment outcomes stratified by region showed that Latin American patients had higher ARR before conversion to GA compared with patients from the other two areas and subsequently experienced the largest reduction in ARR. Latin American patients also had higher baseline rates of comorbidities and relapses with incomplete remissions and improved more than those in the other two regions based on measures of fatigue, quality of life, depression, and cognition scores. Latin American patients also generally had a better perception of the benefits associated with their conversion to GA in terms of efficacy and adverse events. CONCLUSIONS: These findings indicate that, in RRMS patients, converting to GA is associated with positive treatment outcomes regardless of geographic location. However, the reasons for converting and the type and degree of any associated benefits appear to vary depending on various factors, including patients’ geographical location. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12883-015-0448-4) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-4599648
institution National Center for Biotechnology Information
language English
publishDate 2015
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-45996482015-10-10 Sub-analysis of geographical variations in the 2-year observational COPTIMIZE trial of patients with relapsing–remitting multiple sclerosis converting to glatiramer acetate Ziemssen, Tjalf Gilgun-Sherki, Yossi BMC Neurol Research Article BACKGROUND: Studies suggest that patients with relapsing–remitting multiple sclerosis (RRMS) who fail to benefit from a disease-modifying treatment (DMT) may benefit from converting to another DMT class. COPTIMIZE was a 24-month observational study designed to assess the disease course of patients converting to glatiramer acetate (GA) 20 mg daily from another DMT and the association of disease characteristics and reasons for converting. This sub-analysis was to determine if any findings varied by three geographic locations: Latin America (LA), Canada and Western Europe (CWE), and Eastern Europe (EE). METHODS: A total of 668 patients were included (263 LA, 248 CWE, 157 EE) in an analysis of annualized relapse rate (ARR) and annualized rate of deterioration (ARD), as well as secondary endpoints including reason for DMT switch and changes in disability and fatigue scores. Repeated-measures analysis of variance and log transformation were used to analyze ARR and ARD, whereas the Wilcoxon signed rank test was used for secondary endpoints. RESULTS: The sub-analysis of treatment outcomes stratified by region showed that Latin American patients had higher ARR before conversion to GA compared with patients from the other two areas and subsequently experienced the largest reduction in ARR. Latin American patients also had higher baseline rates of comorbidities and relapses with incomplete remissions and improved more than those in the other two regions based on measures of fatigue, quality of life, depression, and cognition scores. Latin American patients also generally had a better perception of the benefits associated with their conversion to GA in terms of efficacy and adverse events. CONCLUSIONS: These findings indicate that, in RRMS patients, converting to GA is associated with positive treatment outcomes regardless of geographic location. However, the reasons for converting and the type and degree of any associated benefits appear to vary depending on various factors, including patients’ geographical location. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12883-015-0448-4) contains supplementary material, which is available to authorized users. BioMed Central 2015-10-08 /pmc/articles/PMC4599648/ /pubmed/26450155 http://dx.doi.org/10.1186/s12883-015-0448-4 Text en © Ziemssen and Gilgun-Sherki. 2015 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Ziemssen, Tjalf
Gilgun-Sherki, Yossi
Sub-analysis of geographical variations in the 2-year observational COPTIMIZE trial of patients with relapsing–remitting multiple sclerosis converting to glatiramer acetate
title Sub-analysis of geographical variations in the 2-year observational COPTIMIZE trial of patients with relapsing–remitting multiple sclerosis converting to glatiramer acetate
title_full Sub-analysis of geographical variations in the 2-year observational COPTIMIZE trial of patients with relapsing–remitting multiple sclerosis converting to glatiramer acetate
title_fullStr Sub-analysis of geographical variations in the 2-year observational COPTIMIZE trial of patients with relapsing–remitting multiple sclerosis converting to glatiramer acetate
title_full_unstemmed Sub-analysis of geographical variations in the 2-year observational COPTIMIZE trial of patients with relapsing–remitting multiple sclerosis converting to glatiramer acetate
title_short Sub-analysis of geographical variations in the 2-year observational COPTIMIZE trial of patients with relapsing–remitting multiple sclerosis converting to glatiramer acetate
title_sort sub-analysis of geographical variations in the 2-year observational coptimize trial of patients with relapsing–remitting multiple sclerosis converting to glatiramer acetate
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4599648/
https://www.ncbi.nlm.nih.gov/pubmed/26450155
http://dx.doi.org/10.1186/s12883-015-0448-4
work_keys_str_mv AT ziemssentjalf subanalysisofgeographicalvariationsinthe2yearobservationalcoptimizetrialofpatientswithrelapsingremittingmultiplesclerosisconvertingtoglatirameracetate
AT gilgunsherkiyossi subanalysisofgeographicalvariationsinthe2yearobservationalcoptimizetrialofpatientswithrelapsingremittingmultiplesclerosisconvertingtoglatirameracetate