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Benralizumab in Patients With Severe Eosinophilic Asthma With and Without Chronic Rhinosinusitis With Nasal Polyps: An ANANKE Study post-hoc Analysis
BACKGROUND: Severe eosinophilic asthma (SEA) in the presence of chronic rhinosinusitis with nasal polyps (CRSwNP) indicates the presence of a more extensive eosinophilic inflammation. Post-hoc analyses from a pivotal clinical trial have demonstrated the enhanced efficacy of benralizumab on asthma ou...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Frontiers Media S.A.
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9234857/ https://www.ncbi.nlm.nih.gov/pubmed/35769575 http://dx.doi.org/10.3389/falgy.2022.881218 |
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author | D'Amato, Maria Menzella, Francesco Altieri, Elena Bargagli, Elena Bracciale, Pietro Brussino, Luisa Caiaffa, Maria Filomena Canonica, Giorgio Walter Caruso, Cristiano Centanni, Stefano De Michele, Fausto Di Marco, Fabiano Pastorello, Elide Anna Pelaia, Girolamo Rogliani, Paola Romagnoli, Micaela Schino, Pietro Senna, Gianenrico Vultaggio, Alessandra Ori, Alessandra Simoni, Lucia Boarino, Silvia Vitiello, Gianfranco Aliani, Maria Del Giacco, Stefano |
author_facet | D'Amato, Maria Menzella, Francesco Altieri, Elena Bargagli, Elena Bracciale, Pietro Brussino, Luisa Caiaffa, Maria Filomena Canonica, Giorgio Walter Caruso, Cristiano Centanni, Stefano De Michele, Fausto Di Marco, Fabiano Pastorello, Elide Anna Pelaia, Girolamo Rogliani, Paola Romagnoli, Micaela Schino, Pietro Senna, Gianenrico Vultaggio, Alessandra Ori, Alessandra Simoni, Lucia Boarino, Silvia Vitiello, Gianfranco Aliani, Maria Del Giacco, Stefano |
author_sort | D'Amato, Maria |
collection | PubMed |
description | BACKGROUND: Severe eosinophilic asthma (SEA) in the presence of chronic rhinosinusitis with nasal polyps (CRSwNP) indicates the presence of a more extensive eosinophilic inflammation. Post-hoc analyses from a pivotal clinical trial have demonstrated the enhanced efficacy of benralizumab on asthma outcomes in patients with CRSwNP as a comorbidity. METHODS: This is a post-hoc analysis from the Italian multi-center observational retrospective ANANKE study. Patients were divided into two groups based on self-reported CRSwNP. Baseline clinical and laboratory features in the 12 months prior to benralizumab prescription were collected. Data of change over time of blood eosinophils, annualized exacerbations rates (AER), asthma control, lung function, oral corticosteroids (OCS) use, and benralizumab discontinuation were collected during the observation period. RESULTS: At baseline, the 110 patients with CRSwNP were less frequently female (50.9% vs 74.2%) and obese (9.1% vs. 22.6%) with higher eosinophils (605 vs. 500 cells/mm(3)) and OCS use when compared to patients without CRSwNP. Similar reductions of AER were seen (-95.8% vs. −91.5% for any exacerbation and −99.1% vs. −92.2% for severe exacerbations in patients with and without CRSwNP, respectively). During benralizumab treatment, comorbid SEA+CRSwNP was associated with a lower risk of any exacerbation (p = 0.0017) and severe exacerbations (p = 0.025). After a mean ± SD exposure of 10.3 ± 5.0 months, half of the SEA+CRSwNP patients eliminated OCS use. No discontinuation for safety reasons was recorded. CONCLUSIONS: This study helped to confirm the baseline clinical features that distinguish patients with and without CRSwNP being prescribed benralizumab. Numerically enhanced OCS reduction and lower exacerbation risk were observed in patients with SEA and comorbid CRSwNP treated with benralizumab. |
format | Online Article Text |
id | pubmed-9234857 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-92348572022-06-28 Benralizumab in Patients With Severe Eosinophilic Asthma With and Without Chronic Rhinosinusitis With Nasal Polyps: An ANANKE Study post-hoc Analysis D'Amato, Maria Menzella, Francesco Altieri, Elena Bargagli, Elena Bracciale, Pietro Brussino, Luisa Caiaffa, Maria Filomena Canonica, Giorgio Walter Caruso, Cristiano Centanni, Stefano De Michele, Fausto Di Marco, Fabiano Pastorello, Elide Anna Pelaia, Girolamo Rogliani, Paola Romagnoli, Micaela Schino, Pietro Senna, Gianenrico Vultaggio, Alessandra Ori, Alessandra Simoni, Lucia Boarino, Silvia Vitiello, Gianfranco Aliani, Maria Del Giacco, Stefano Front Allergy Allergy BACKGROUND: Severe eosinophilic asthma (SEA) in the presence of chronic rhinosinusitis with nasal polyps (CRSwNP) indicates the presence of a more extensive eosinophilic inflammation. Post-hoc analyses from a pivotal clinical trial have demonstrated the enhanced efficacy of benralizumab on asthma outcomes in patients with CRSwNP as a comorbidity. METHODS: This is a post-hoc analysis from the Italian multi-center observational retrospective ANANKE study. Patients were divided into two groups based on self-reported CRSwNP. Baseline clinical and laboratory features in the 12 months prior to benralizumab prescription were collected. Data of change over time of blood eosinophils, annualized exacerbations rates (AER), asthma control, lung function, oral corticosteroids (OCS) use, and benralizumab discontinuation were collected during the observation period. RESULTS: At baseline, the 110 patients with CRSwNP were less frequently female (50.9% vs 74.2%) and obese (9.1% vs. 22.6%) with higher eosinophils (605 vs. 500 cells/mm(3)) and OCS use when compared to patients without CRSwNP. Similar reductions of AER were seen (-95.8% vs. −91.5% for any exacerbation and −99.1% vs. −92.2% for severe exacerbations in patients with and without CRSwNP, respectively). During benralizumab treatment, comorbid SEA+CRSwNP was associated with a lower risk of any exacerbation (p = 0.0017) and severe exacerbations (p = 0.025). After a mean ± SD exposure of 10.3 ± 5.0 months, half of the SEA+CRSwNP patients eliminated OCS use. No discontinuation for safety reasons was recorded. CONCLUSIONS: This study helped to confirm the baseline clinical features that distinguish patients with and without CRSwNP being prescribed benralizumab. Numerically enhanced OCS reduction and lower exacerbation risk were observed in patients with SEA and comorbid CRSwNP treated with benralizumab. Frontiers Media S.A. 2022-05-18 /pmc/articles/PMC9234857/ /pubmed/35769575 http://dx.doi.org/10.3389/falgy.2022.881218 Text en Copyright © 2022 D'Amato, Menzella, Altieri, Bargagli, Bracciale, Brussino, Caiaffa, Canonica, Caruso, Centanni, De Michele, Di Marco, Pastorello, Pelaia, Rogliani, Romagnoli, Schino, Senna, Vultaggio, Ori, Simoni, Boarino, Vitiello, Aliani and Del Giacco. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Allergy D'Amato, Maria Menzella, Francesco Altieri, Elena Bargagli, Elena Bracciale, Pietro Brussino, Luisa Caiaffa, Maria Filomena Canonica, Giorgio Walter Caruso, Cristiano Centanni, Stefano De Michele, Fausto Di Marco, Fabiano Pastorello, Elide Anna Pelaia, Girolamo Rogliani, Paola Romagnoli, Micaela Schino, Pietro Senna, Gianenrico Vultaggio, Alessandra Ori, Alessandra Simoni, Lucia Boarino, Silvia Vitiello, Gianfranco Aliani, Maria Del Giacco, Stefano Benralizumab in Patients With Severe Eosinophilic Asthma With and Without Chronic Rhinosinusitis With Nasal Polyps: An ANANKE Study post-hoc Analysis |
title | Benralizumab in Patients With Severe Eosinophilic Asthma With and Without Chronic Rhinosinusitis With Nasal Polyps: An ANANKE Study post-hoc Analysis |
title_full | Benralizumab in Patients With Severe Eosinophilic Asthma With and Without Chronic Rhinosinusitis With Nasal Polyps: An ANANKE Study post-hoc Analysis |
title_fullStr | Benralizumab in Patients With Severe Eosinophilic Asthma With and Without Chronic Rhinosinusitis With Nasal Polyps: An ANANKE Study post-hoc Analysis |
title_full_unstemmed | Benralizumab in Patients With Severe Eosinophilic Asthma With and Without Chronic Rhinosinusitis With Nasal Polyps: An ANANKE Study post-hoc Analysis |
title_short | Benralizumab in Patients With Severe Eosinophilic Asthma With and Without Chronic Rhinosinusitis With Nasal Polyps: An ANANKE Study post-hoc Analysis |
title_sort | benralizumab in patients with severe eosinophilic asthma with and without chronic rhinosinusitis with nasal polyps: an ananke study post-hoc analysis |
topic | Allergy |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9234857/ https://www.ncbi.nlm.nih.gov/pubmed/35769575 http://dx.doi.org/10.3389/falgy.2022.881218 |
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