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NEDA-3 status including cortical lesions in the comparative evaluation of natalizumab versus fingolimod efficacy in multiple sclerosis

BACKGROUND: Cortical lesions (CLs) are typical of multiple sclerosis (MS) and have been recently incorporated in MS diagnostic criteria. Thus, the ‘no evidence of disease activity’ (NEDA) definition should now include CLs. The aim of this study was to evaluate the NEDA3 + CL status in natalizumab- o...

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Autores principales: Puthenparampil, Marco, Cazzola, Chiara, Zywicki, Sofia, Federle, Lisa, Stropparo, Erica, Anglani, Mariagiulia, Rinaldi, Francesca, Perini, Paola, Gallo, Paolo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6204617/
https://www.ncbi.nlm.nih.gov/pubmed/30386435
http://dx.doi.org/10.1177/1756286418805713
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author Puthenparampil, Marco
Cazzola, Chiara
Zywicki, Sofia
Federle, Lisa
Stropparo, Erica
Anglani, Mariagiulia
Rinaldi, Francesca
Perini, Paola
Gallo, Paolo
author_facet Puthenparampil, Marco
Cazzola, Chiara
Zywicki, Sofia
Federle, Lisa
Stropparo, Erica
Anglani, Mariagiulia
Rinaldi, Francesca
Perini, Paola
Gallo, Paolo
author_sort Puthenparampil, Marco
collection PubMed
description BACKGROUND: Cortical lesions (CLs) are typical of multiple sclerosis (MS) and have been recently incorporated in MS diagnostic criteria. Thus, the ‘no evidence of disease activity’ (NEDA) definition should now include CLs. The aim of this study was to evaluate the NEDA3 + CL status in natalizumab- or fingolimod-treated relapsing remitting MS (RMS) patients. METHODS: Natalizumab- or fingolimod-treated RMS patients were enrolled in a 2-year longitudinal study based on clinical and magnetic resonance imaging (MRI) evaluations performed respectively biannually and annually. CLs were detected by double inversion recovery. The NEDA3 + CL condition was evaluated at baseline (T0) and at the end of the first (T1) and second (T2) year. RESULTS: Of the 137 RMS patients included in the study, 86 were propensity-matched. At T2, the annualized relapse rate was lower on natalizumab (p = 0.021), but the effect on white matter lesions (p = 0.29) and the proportion of NEDA-3 patients (p = 0.14) were similar in the two treatment arms. At T2, 11.6% natalizumab- and 62.8% fingolimod-treated patients had new CLs (p < 0.001) and a higher proportion of natalizumab-treated patients (55.8% versus 11.6%, p < 0.001) achieved the NEDA3 + CL status (hazard ratio 5.2, p < 0.001). CONCLUSION: The incorporation of CLs in the NEDA-3 definition highlighted the higher efficacy of natalizumab versus fingolimod in suppressing disease activity in RMS patients.
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spelling pubmed-62046172018-10-31 NEDA-3 status including cortical lesions in the comparative evaluation of natalizumab versus fingolimod efficacy in multiple sclerosis Puthenparampil, Marco Cazzola, Chiara Zywicki, Sofia Federle, Lisa Stropparo, Erica Anglani, Mariagiulia Rinaldi, Francesca Perini, Paola Gallo, Paolo Ther Adv Neurol Disord Original Research BACKGROUND: Cortical lesions (CLs) are typical of multiple sclerosis (MS) and have been recently incorporated in MS diagnostic criteria. Thus, the ‘no evidence of disease activity’ (NEDA) definition should now include CLs. The aim of this study was to evaluate the NEDA3 + CL status in natalizumab- or fingolimod-treated relapsing remitting MS (RMS) patients. METHODS: Natalizumab- or fingolimod-treated RMS patients were enrolled in a 2-year longitudinal study based on clinical and magnetic resonance imaging (MRI) evaluations performed respectively biannually and annually. CLs were detected by double inversion recovery. The NEDA3 + CL condition was evaluated at baseline (T0) and at the end of the first (T1) and second (T2) year. RESULTS: Of the 137 RMS patients included in the study, 86 were propensity-matched. At T2, the annualized relapse rate was lower on natalizumab (p = 0.021), but the effect on white matter lesions (p = 0.29) and the proportion of NEDA-3 patients (p = 0.14) were similar in the two treatment arms. At T2, 11.6% natalizumab- and 62.8% fingolimod-treated patients had new CLs (p < 0.001) and a higher proportion of natalizumab-treated patients (55.8% versus 11.6%, p < 0.001) achieved the NEDA3 + CL status (hazard ratio 5.2, p < 0.001). CONCLUSION: The incorporation of CLs in the NEDA-3 definition highlighted the higher efficacy of natalizumab versus fingolimod in suppressing disease activity in RMS patients. SAGE Publications 2018-10-25 /pmc/articles/PMC6204617/ /pubmed/30386435 http://dx.doi.org/10.1177/1756286418805713 Text en © The Author(s), 2018 http://www.creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Research
Puthenparampil, Marco
Cazzola, Chiara
Zywicki, Sofia
Federle, Lisa
Stropparo, Erica
Anglani, Mariagiulia
Rinaldi, Francesca
Perini, Paola
Gallo, Paolo
NEDA-3 status including cortical lesions in the comparative evaluation of natalizumab versus fingolimod efficacy in multiple sclerosis
title NEDA-3 status including cortical lesions in the comparative evaluation of natalizumab versus fingolimod efficacy in multiple sclerosis
title_full NEDA-3 status including cortical lesions in the comparative evaluation of natalizumab versus fingolimod efficacy in multiple sclerosis
title_fullStr NEDA-3 status including cortical lesions in the comparative evaluation of natalizumab versus fingolimod efficacy in multiple sclerosis
title_full_unstemmed NEDA-3 status including cortical lesions in the comparative evaluation of natalizumab versus fingolimod efficacy in multiple sclerosis
title_short NEDA-3 status including cortical lesions in the comparative evaluation of natalizumab versus fingolimod efficacy in multiple sclerosis
title_sort neda-3 status including cortical lesions in the comparative evaluation of natalizumab versus fingolimod efficacy in multiple sclerosis
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6204617/
https://www.ncbi.nlm.nih.gov/pubmed/30386435
http://dx.doi.org/10.1177/1756286418805713
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