Cargando…

Differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon

BACKGROUND: In the treatment of multiple sclerosis, a change of therapy is considered after treatment failure or adverse events. Although disease modifying drugs’ (DMD) efficacy and side effects have been fully analysed in clinical trials, the effects of previous therapy use are less well studied. W...

Descripción completa

Detalles Bibliográficos
Autores principales: Fernández-Fournier, Mireya, Tallón-Barranco, Antonio, Chamorro, Beatriz, Martínez-Sánchez, Patricia, Puertas, Inmaculada
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4545781/
https://www.ncbi.nlm.nih.gov/pubmed/26286576
http://dx.doi.org/10.1186/s12883-015-0399-9
_version_ 1782386783006228480
author Fernández-Fournier, Mireya
Tallón-Barranco, Antonio
Chamorro, Beatriz
Martínez-Sánchez, Patricia
Puertas, Inmaculada
author_facet Fernández-Fournier, Mireya
Tallón-Barranco, Antonio
Chamorro, Beatriz
Martínez-Sánchez, Patricia
Puertas, Inmaculada
author_sort Fernández-Fournier, Mireya
collection PubMed
description BACKGROUND: In the treatment of multiple sclerosis, a change of therapy is considered after treatment failure or adverse events. Although disease modifying drugs’ (DMD) efficacy and side effects have been fully analysed in clinical trials, the effects of previous therapy use are less well studied. We aimed to study medication persistence with glatiramer acetate in treatment-naive patients and in patients previously treated with interferon. METHODS: A retrospective study of relapsing-remitting multiple sclerosis patients treated with glatiramer acetate in an MS Unit of a Spanish University Hospital (January 2004 – September 2013). Treatment time on glatiramer acetate was studied. Reasons for treatment discontinuation were considered as follows: lack of efficacy, serious adverse event, injection-related side effect, pregnancy and lost to follow-up. Use of prior DMD was registered and analysed. Homogeneity of groups was analysed using Fisher's and Mann-Whitney’s tests. The Kaplan Meier method and Cox regression model were used to estimate time to and risk of treatment discontinuation. RESULTS: In total, 155 relapsing-remitting multiple sclerosis patients were treated with glatiramer acetate: 100 treatment-naive patients and 55 treated previously with interferon. At the end of the study, 76 patients (49.0 %) continued on glatiramer acetate (with an average treatment time (ATT) of 50.4 months, s.d.32.8) and 50 patients (32.3 %) had switched therapy: 27 patients (17.4 %) for inefficacy (ATT 29.2 months, s.d.17.5), 20 patients (12.9 %) for injection site reactions (ATT 16.5 months, s.d.20.3) and 3 patients (1.9 %) after serious adverse events (ATT 15.7 months, s.d.15.1). ATT in our cohort was 39 months (s.d.30.0), median follow-up 34 months. Six months after glatiramer acetate initiation, probability of persisting on GA was 91.4 %, 82.5 % after 12 months and 72.5 % after 2 years. The risk of glatiramer acetate treatment discontinuation was 2.8 [1.7 – 4.8] times greater for treatment-naive patients than for patients treated previously with interferon and this was hardly modified after adjusting for sex and age. CONCLUSIONS: Glatiramer acetate was safe and useful with low rates of serious adverse events and low rates of break-through disease. Injection intolerance proved a major limitation to glatiramer acetate use. Patients who had been previously treated with interferons presented a lower probability of glatiramer acetate discontinuation than treatment-naive patients.
format Online
Article
Text
id pubmed-4545781
institution National Center for Biotechnology Information
language English
publishDate 2015
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-45457812015-08-23 Differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon Fernández-Fournier, Mireya Tallón-Barranco, Antonio Chamorro, Beatriz Martínez-Sánchez, Patricia Puertas, Inmaculada BMC Neurol Research Article BACKGROUND: In the treatment of multiple sclerosis, a change of therapy is considered after treatment failure or adverse events. Although disease modifying drugs’ (DMD) efficacy and side effects have been fully analysed in clinical trials, the effects of previous therapy use are less well studied. We aimed to study medication persistence with glatiramer acetate in treatment-naive patients and in patients previously treated with interferon. METHODS: A retrospective study of relapsing-remitting multiple sclerosis patients treated with glatiramer acetate in an MS Unit of a Spanish University Hospital (January 2004 – September 2013). Treatment time on glatiramer acetate was studied. Reasons for treatment discontinuation were considered as follows: lack of efficacy, serious adverse event, injection-related side effect, pregnancy and lost to follow-up. Use of prior DMD was registered and analysed. Homogeneity of groups was analysed using Fisher's and Mann-Whitney’s tests. The Kaplan Meier method and Cox regression model were used to estimate time to and risk of treatment discontinuation. RESULTS: In total, 155 relapsing-remitting multiple sclerosis patients were treated with glatiramer acetate: 100 treatment-naive patients and 55 treated previously with interferon. At the end of the study, 76 patients (49.0 %) continued on glatiramer acetate (with an average treatment time (ATT) of 50.4 months, s.d.32.8) and 50 patients (32.3 %) had switched therapy: 27 patients (17.4 %) for inefficacy (ATT 29.2 months, s.d.17.5), 20 patients (12.9 %) for injection site reactions (ATT 16.5 months, s.d.20.3) and 3 patients (1.9 %) after serious adverse events (ATT 15.7 months, s.d.15.1). ATT in our cohort was 39 months (s.d.30.0), median follow-up 34 months. Six months after glatiramer acetate initiation, probability of persisting on GA was 91.4 %, 82.5 % after 12 months and 72.5 % after 2 years. The risk of glatiramer acetate treatment discontinuation was 2.8 [1.7 – 4.8] times greater for treatment-naive patients than for patients treated previously with interferon and this was hardly modified after adjusting for sex and age. CONCLUSIONS: Glatiramer acetate was safe and useful with low rates of serious adverse events and low rates of break-through disease. Injection intolerance proved a major limitation to glatiramer acetate use. Patients who had been previously treated with interferons presented a lower probability of glatiramer acetate discontinuation than treatment-naive patients. BioMed Central 2015-08-19 /pmc/articles/PMC4545781/ /pubmed/26286576 http://dx.doi.org/10.1186/s12883-015-0399-9 Text en © Fernández-Fournier et al. 2015 Open Access This 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
Fernández-Fournier, Mireya
Tallón-Barranco, Antonio
Chamorro, Beatriz
Martínez-Sánchez, Patricia
Puertas, Inmaculada
Differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon
title Differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon
title_full Differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon
title_fullStr Differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon
title_full_unstemmed Differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon
title_short Differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon
title_sort differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4545781/
https://www.ncbi.nlm.nih.gov/pubmed/26286576
http://dx.doi.org/10.1186/s12883-015-0399-9
work_keys_str_mv AT fernandezfourniermireya differentialglatirameracetatetreatmentpersistenceintreatmentnaivepatientscomparedtopatientspreviouslytreatedwithinterferon
AT tallonbarrancoantonio differentialglatirameracetatetreatmentpersistenceintreatmentnaivepatientscomparedtopatientspreviouslytreatedwithinterferon
AT chamorrobeatriz differentialglatirameracetatetreatmentpersistenceintreatmentnaivepatientscomparedtopatientspreviouslytreatedwithinterferon
AT martinezsanchezpatricia differentialglatirameracetatetreatmentpersistenceintreatmentnaivepatientscomparedtopatientspreviouslytreatedwithinterferon
AT puertasinmaculada differentialglatirameracetatetreatmentpersistenceintreatmentnaivepatientscomparedtopatientspreviouslytreatedwithinterferon