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Efficacy of fingolimod and interferon beta-1b on cognitive, MRI, and clinical outcomes in relapsing–remitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the GOLDEN study)
Cognitive impairment (CI) affects 40–65% of multiple sclerosis (MS) patients. This study attempted evaluating the effects of fingolimod and interferon beta-1b (IFN β-1b) on CI progression, magnetic resonance imaging (MRI) and clinical outcomes in relapsing–remitting MS (RRMS) patients over 18 months...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Berlin Heidelberg
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5688215/ https://www.ncbi.nlm.nih.gov/pubmed/29063244 http://dx.doi.org/10.1007/s00415-017-8642-5 |
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author | Comi, Giancarlo Patti, Francesco Rocca, Maria Assunta Mattioli, Flavia Caterina Amato, Maria Pia Gallo, Paolo Centonze, Diego Pozzilli, Carlo Saccà, Francesco Bergh, Florian Then Bartezaghi, Marta Turrini, Renato Filippi, Massimo |
author_facet | Comi, Giancarlo Patti, Francesco Rocca, Maria Assunta Mattioli, Flavia Caterina Amato, Maria Pia Gallo, Paolo Centonze, Diego Pozzilli, Carlo Saccà, Francesco Bergh, Florian Then Bartezaghi, Marta Turrini, Renato Filippi, Massimo |
author_sort | Comi, Giancarlo |
collection | PubMed |
description | Cognitive impairment (CI) affects 40–65% of multiple sclerosis (MS) patients. This study attempted evaluating the effects of fingolimod and interferon beta-1b (IFN β-1b) on CI progression, magnetic resonance imaging (MRI) and clinical outcomes in relapsing–remitting MS (RRMS) patients over 18 months. The GOLDEN study was a pilot study including RRMS patients with CI randomised (2:1) to fingolimod (0.5 mg daily)/IFN β-1b (250 µg every other day). CI was assessed via Rao’s Brief Repeatable Battery and Delis–Kaplan Executive Function System test. MRI parameters, Expanded Disability Status Scale scores and relapses were measured. Overall, 157 patients were randomised, of whom 30 discontinued the study (fingolimod, 8.49%; IFN β-1b, 41.18%; p ≤ 0.0001). Patients randomised to fingolimod had more severe clinical and MRI disease characteristics at baseline compared with IFN β-1b. At Month (M) 18, both treatment groups showed improvements in all cognitive parameters. At M18, relapse rate, total number and volume of T2/T1 gadolinium-enhancing lesions were higher with IFN β-1b, as well as the percentage brain volume change during the study. Safety and tolerability of both treatments were similar to previous studies. Both treatments showed improvements in cognitive parameters. Fingolimod demonstrated significantly better effects on MRI parameters and relapse rate. Imbalance in baseline characteristics and the drop-out pattern may have favoured IFN β-1b. A longer duration trial may be needed to observe the complete expression of differential effects on CI scales reflecting the between-groups differences on MRI. Although limited in size, the GOLDEN study confirms the favourable benefit–risk profile of fingolimod reported in previous studies. |
format | Online Article Text |
id | pubmed-5688215 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Springer Berlin Heidelberg |
record_format | MEDLINE/PubMed |
spelling | pubmed-56882152017-11-30 Efficacy of fingolimod and interferon beta-1b on cognitive, MRI, and clinical outcomes in relapsing–remitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the GOLDEN study) Comi, Giancarlo Patti, Francesco Rocca, Maria Assunta Mattioli, Flavia Caterina Amato, Maria Pia Gallo, Paolo Centonze, Diego Pozzilli, Carlo Saccà, Francesco Bergh, Florian Then Bartezaghi, Marta Turrini, Renato Filippi, Massimo J Neurol Original Communication Cognitive impairment (CI) affects 40–65% of multiple sclerosis (MS) patients. This study attempted evaluating the effects of fingolimod and interferon beta-1b (IFN β-1b) on CI progression, magnetic resonance imaging (MRI) and clinical outcomes in relapsing–remitting MS (RRMS) patients over 18 months. The GOLDEN study was a pilot study including RRMS patients with CI randomised (2:1) to fingolimod (0.5 mg daily)/IFN β-1b (250 µg every other day). CI was assessed via Rao’s Brief Repeatable Battery and Delis–Kaplan Executive Function System test. MRI parameters, Expanded Disability Status Scale scores and relapses were measured. Overall, 157 patients were randomised, of whom 30 discontinued the study (fingolimod, 8.49%; IFN β-1b, 41.18%; p ≤ 0.0001). Patients randomised to fingolimod had more severe clinical and MRI disease characteristics at baseline compared with IFN β-1b. At Month (M) 18, both treatment groups showed improvements in all cognitive parameters. At M18, relapse rate, total number and volume of T2/T1 gadolinium-enhancing lesions were higher with IFN β-1b, as well as the percentage brain volume change during the study. Safety and tolerability of both treatments were similar to previous studies. Both treatments showed improvements in cognitive parameters. Fingolimod demonstrated significantly better effects on MRI parameters and relapse rate. Imbalance in baseline characteristics and the drop-out pattern may have favoured IFN β-1b. A longer duration trial may be needed to observe the complete expression of differential effects on CI scales reflecting the between-groups differences on MRI. Although limited in size, the GOLDEN study confirms the favourable benefit–risk profile of fingolimod reported in previous studies. Springer Berlin Heidelberg 2017-10-23 2017 /pmc/articles/PMC5688215/ /pubmed/29063244 http://dx.doi.org/10.1007/s00415-017-8642-5 Text en © The Author(s) 2017 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. |
spellingShingle | Original Communication Comi, Giancarlo Patti, Francesco Rocca, Maria Assunta Mattioli, Flavia Caterina Amato, Maria Pia Gallo, Paolo Centonze, Diego Pozzilli, Carlo Saccà, Francesco Bergh, Florian Then Bartezaghi, Marta Turrini, Renato Filippi, Massimo Efficacy of fingolimod and interferon beta-1b on cognitive, MRI, and clinical outcomes in relapsing–remitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the GOLDEN study) |
title | Efficacy of fingolimod and interferon beta-1b on cognitive, MRI, and clinical outcomes in relapsing–remitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the GOLDEN study) |
title_full | Efficacy of fingolimod and interferon beta-1b on cognitive, MRI, and clinical outcomes in relapsing–remitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the GOLDEN study) |
title_fullStr | Efficacy of fingolimod and interferon beta-1b on cognitive, MRI, and clinical outcomes in relapsing–remitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the GOLDEN study) |
title_full_unstemmed | Efficacy of fingolimod and interferon beta-1b on cognitive, MRI, and clinical outcomes in relapsing–remitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the GOLDEN study) |
title_short | Efficacy of fingolimod and interferon beta-1b on cognitive, MRI, and clinical outcomes in relapsing–remitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the GOLDEN study) |
title_sort | efficacy of fingolimod and interferon beta-1b on cognitive, mri, and clinical outcomes in relapsing–remitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the golden study) |
topic | Original Communication |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5688215/ https://www.ncbi.nlm.nih.gov/pubmed/29063244 http://dx.doi.org/10.1007/s00415-017-8642-5 |
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