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Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing–Remitting Multiple Sclerosis: STRIVE Data Analysis

INTRODUCTION: In STRIVE, natalizumab treatment demonstrated effectiveness in clinical, magnetic resonance imaging (MRI), and patient-reported outcomes (PROs) in patients with early relapsing–remitting multiple sclerosis (RRMS). This post hoc analysis examined the effectiveness and safety of natalizu...

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Autores principales: Perumal, Jai, Balabanov, Roumen, Balcer, Laura, Galetta, Steven, Sun, Zhaonan, Li, Hanyue, Rutledge, Danette, Avila, Robin L., Fox, Robert J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10195921/
https://www.ncbi.nlm.nih.gov/pubmed/36966440
http://dx.doi.org/10.1007/s40120-023-00461-0
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author Perumal, Jai
Balabanov, Roumen
Balcer, Laura
Galetta, Steven
Sun, Zhaonan
Li, Hanyue
Rutledge, Danette
Avila, Robin L.
Fox, Robert J.
author_facet Perumal, Jai
Balabanov, Roumen
Balcer, Laura
Galetta, Steven
Sun, Zhaonan
Li, Hanyue
Rutledge, Danette
Avila, Robin L.
Fox, Robert J.
author_sort Perumal, Jai
collection PubMed
description INTRODUCTION: In STRIVE, natalizumab treatment demonstrated effectiveness in clinical, magnetic resonance imaging (MRI), and patient-reported outcomes (PROs) in patients with early relapsing–remitting multiple sclerosis (RRMS). This post hoc analysis examined the effectiveness and safety of natalizumab in patients who self-identified as either Black/African American (AA) or Hispanic/Latino. METHODS: Clinical, MRI, and PROs were assessed for the Black/AA subgroup (n = 40) and compared with the non-Hispanic White subgroup (n = 158). As a result of the very small sample size, outcomes for the Hispanic/Latino subgroup (n = 18) were assessed separately, including a sensitivity analysis with Hispanic/Latino patients who completed the 4-year study on natalizumab. RESULTS: Clinical, MRI, and PROs were comparable between the Black/AA and non-Hispanic White subgroups except for MRI outcomes at year 1. A higher proportion of non-Hispanic White than Black/AA patients achieved MRI no evidence of disease activity (NEDA; 75.4% vs. 50.0%, p = 0.0121) and no new or newly enlarging T2 lesions (77.6% vs. 50.0%, p = 0.0031) at year 1; these differences were not observed in years 2–4 of the study. For the Hispanic/Latino subgroup in the intent-to-treat population, 46.2% and 55.6% achieved NEDA at years 1 and 2; 66.7% and 90.0% achieved clinical NEDA at years 3 and 4. Annualized relapse rate was reduced by 93.0% at year 1 versus the year before natalizumab initiation; this reduction was maintained throughout the study. Over 4 years, 37.5–50.0% of patients had a clinically meaningful improvement in their Symbol Digit Modalities Test score, and 81.8–100.0% and 90.9–100.0% had stable/improved Multiple Sclerosis Impact Scale-29 physical and psychological scores, respectively. Similar results were observed in the sensitivity analysis with Hispanic/Latino subgroup of the 4-year natalizumab completers. CONCLUSION: These results highlight the effectiveness and safety of natalizumab in patients with early RRMS who self-identified as Black/AA or Hispanic/Latino. CLINICALTRIALS.GOV: NCT01485003. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40120-023-00461-0.
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spelling pubmed-101959212023-05-20 Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing–Remitting Multiple Sclerosis: STRIVE Data Analysis Perumal, Jai Balabanov, Roumen Balcer, Laura Galetta, Steven Sun, Zhaonan Li, Hanyue Rutledge, Danette Avila, Robin L. Fox, Robert J. Neurol Ther Original Research INTRODUCTION: In STRIVE, natalizumab treatment demonstrated effectiveness in clinical, magnetic resonance imaging (MRI), and patient-reported outcomes (PROs) in patients with early relapsing–remitting multiple sclerosis (RRMS). This post hoc analysis examined the effectiveness and safety of natalizumab in patients who self-identified as either Black/African American (AA) or Hispanic/Latino. METHODS: Clinical, MRI, and PROs were assessed for the Black/AA subgroup (n = 40) and compared with the non-Hispanic White subgroup (n = 158). As a result of the very small sample size, outcomes for the Hispanic/Latino subgroup (n = 18) were assessed separately, including a sensitivity analysis with Hispanic/Latino patients who completed the 4-year study on natalizumab. RESULTS: Clinical, MRI, and PROs were comparable between the Black/AA and non-Hispanic White subgroups except for MRI outcomes at year 1. A higher proportion of non-Hispanic White than Black/AA patients achieved MRI no evidence of disease activity (NEDA; 75.4% vs. 50.0%, p = 0.0121) and no new or newly enlarging T2 lesions (77.6% vs. 50.0%, p = 0.0031) at year 1; these differences were not observed in years 2–4 of the study. For the Hispanic/Latino subgroup in the intent-to-treat population, 46.2% and 55.6% achieved NEDA at years 1 and 2; 66.7% and 90.0% achieved clinical NEDA at years 3 and 4. Annualized relapse rate was reduced by 93.0% at year 1 versus the year before natalizumab initiation; this reduction was maintained throughout the study. Over 4 years, 37.5–50.0% of patients had a clinically meaningful improvement in their Symbol Digit Modalities Test score, and 81.8–100.0% and 90.9–100.0% had stable/improved Multiple Sclerosis Impact Scale-29 physical and psychological scores, respectively. Similar results were observed in the sensitivity analysis with Hispanic/Latino subgroup of the 4-year natalizumab completers. CONCLUSION: These results highlight the effectiveness and safety of natalizumab in patients with early RRMS who self-identified as Black/AA or Hispanic/Latino. CLINICALTRIALS.GOV: NCT01485003. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40120-023-00461-0. Springer Healthcare 2023-03-26 /pmc/articles/PMC10195921/ /pubmed/36966440 http://dx.doi.org/10.1007/s40120-023-00461-0 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Perumal, Jai
Balabanov, Roumen
Balcer, Laura
Galetta, Steven
Sun, Zhaonan
Li, Hanyue
Rutledge, Danette
Avila, Robin L.
Fox, Robert J.
Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing–Remitting Multiple Sclerosis: STRIVE Data Analysis
title Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing–Remitting Multiple Sclerosis: STRIVE Data Analysis
title_full Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing–Remitting Multiple Sclerosis: STRIVE Data Analysis
title_fullStr Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing–Remitting Multiple Sclerosis: STRIVE Data Analysis
title_full_unstemmed Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing–Remitting Multiple Sclerosis: STRIVE Data Analysis
title_short Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing–Remitting Multiple Sclerosis: STRIVE Data Analysis
title_sort long-term effectiveness and safety of natalizumab in african american and hispanic/latino patients with early relapsing–remitting multiple sclerosis: strive data analysis
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10195921/
https://www.ncbi.nlm.nih.gov/pubmed/36966440
http://dx.doi.org/10.1007/s40120-023-00461-0
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