Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma

Five biologicals have been approved for severe eosinophilic asthma, a well-recognized phenotype. Systematic reviews (SR) evaluated the efficacy and safety of benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab (alphabetical order) compared to standard of care for severe eosinophilic asth...

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Autores: Agache, I, Beltran, J, Akdis, C, Akdis, M, Canelo-Aybar, C, Canonica, GW, Casale, T, Chivato, T, Corren, J, Del Giacco, S, Eiwegger, T, Firinu, D, Gern, JE, Hamelmann, E, Hanania, N, Makela, M, Martin, IH, Nair, P, O'Mahony, L, Papadopoulos, NG, Papi, A, Park, HS, de Llano, LP, Posso, M, Rocha, C, Quirce, S, Sastre, J, Shamji, M, Song, Y, Steiner, C, Schwarze, J, Alonso-Coello, P, Palomares, O, Jutel, M
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Recursos:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositorio:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p1584
Acesso em linha:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=1584
Access Level:acceso abierto
Palavra-chave:biologicals
cost-effectiveness
efficacy
severe-eosinophilic-asthma
safety
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spelling Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthmaAgache, IBeltran, JAkdis, CAkdis, MCanelo-Aybar, CCanonica, GWCasale, TChivato, TCorren, JDel Giacco, SEiwegger, TFirinu, DGern, JEHamelmann, EHanania, NMakela, MMartin, IHNair, PO'Mahony, LPapadopoulos, NGPapi, APark, HSde Llano, LPPosso, MRocha, CQuirce, SSastre, JShamji, MSong, YSteiner, CSchwarze, JAlonso-Coello, PPalomares, OJutel, Mbiologicalscost-effectivenessefficacysevere-eosinophilic-asthmasafetyFive biologicals have been approved for severe eosinophilic asthma, a well-recognized phenotype. Systematic reviews (SR) evaluated the efficacy and safety of benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab (alphabetical order) compared to standard of care for severe eosinophilic asthma. PubMed, Embase and Cochrane Library were searched to identify RCTs and health economic evaluations, published in English. Critical and important asthma-related outcomes were evaluated for each of the biologicals. The risk of bias and the certainty of the evidence were assessed using GRADE. 19 RCTs (three RCTs for benralizumab, three RCTs for dupilumab, three RCTs for mepolizumab, five RCTs for omalizumab and five RCTs for reslizumab), including subjects 12 to 75 years old (except for omalizumab including also subjects 6-11 years old), ranging from 12 to 56 weeks were evaluated. All biologicals reduce exacerbation rates with high certainty of evidence: benralizumab incidence rate ratio (IRR) 0.53 (95% CI 0.39 to 0.72), dupilumab (IRR) 0.43 (95% CI 0.32 to 0.59), mepolizumab IRR 0.49 (95% CI 0.38 to 0.66), omalizumab (IRR) 0.56 (95% CI 0.40 to 0.77) and reslizumab (IRR) 0.46 (95% CI 0.37 to 0.58). Benralizumab, dupilumab and mepolizumab reduce the daily dose of oral corticosteroids (OCS) with high certainty of evidence. All evaluated biologicals probably improve asthma control, QoL and FEV1, without reaching the minimal important difference (moderate certainty). Benralizumab, mepolizumab and reslizumab slightly increase drug-related adverse events (AE) and drug-related serious AE (low to very low certainty of evidence). The incremental cost-effectiveness ratio per quality-adjusted life year value is above the willingness to pay threshold for all biologicals (moderate certainty). Potential savings are driven by decrease in hospitalizations, emergency and primary care visits. There is high certainty that all approved biologicals reduce the rate of severe asthma exacerbations and for benralizumab, dupilumab and mepolizumab for reducing OCS. There is moderate certainty for improving asthma control, QoL, FEV1. More data on long-term safety are needed together with more efficacy data in the paediatric population.WILEY2020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=1584ALLERGYISSN: 01054538ISSNe: 13989995reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p15842026-06-14T12:41:47Z
dc.title.none.fl_str_mv Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma
title Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma
spellingShingle Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma
Agache, I
biologicals
cost-effectiveness
efficacy
severe-eosinophilic-asthma
safety
title_short Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma
title_full Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma
title_fullStr Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma
title_full_unstemmed Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma
title_sort Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma
dc.creator.none.fl_str_mv Agache, I
Beltran, J
Akdis, C
Akdis, M
Canelo-Aybar, C
Canonica, GW
Casale, T
Chivato, T
Corren, J
Del Giacco, S
Eiwegger, T
Firinu, D
Gern, JE
Hamelmann, E
Hanania, N
Makela, M
Martin, IH
Nair, P
O'Mahony, L
Papadopoulos, NG
Papi, A
Park, HS
de Llano, LP
Posso, M
Rocha, C
Quirce, S
Sastre, J
Shamji, M
Song, Y
Steiner, C
Schwarze, J
Alonso-Coello, P
Palomares, O
Jutel, M
author Agache, I
author_facet Agache, I
Beltran, J
Akdis, C
Akdis, M
Canelo-Aybar, C
Canonica, GW
Casale, T
Chivato, T
Corren, J
Del Giacco, S
Eiwegger, T
Firinu, D
Gern, JE
Hamelmann, E
Hanania, N
Makela, M
Martin, IH
Nair, P
O'Mahony, L
Papadopoulos, NG
Papi, A
Park, HS
de Llano, LP
Posso, M
Rocha, C
Quirce, S
Sastre, J
Shamji, M
Song, Y
Steiner, C
Schwarze, J
Alonso-Coello, P
Palomares, O
Jutel, M
author_role author
author2 Beltran, J
Akdis, C
Akdis, M
Canelo-Aybar, C
Canonica, GW
Casale, T
Chivato, T
Corren, J
Del Giacco, S
Eiwegger, T
Firinu, D
Gern, JE
Hamelmann, E
Hanania, N
Makela, M
Martin, IH
Nair, P
O'Mahony, L
Papadopoulos, NG
Papi, A
Park, HS
de Llano, LP
Posso, M
Rocha, C
Quirce, S
Sastre, J
Shamji, M
Song, Y
Steiner, C
Schwarze, J
Alonso-Coello, P
Palomares, O
Jutel, M
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv biologicals
cost-effectiveness
efficacy
severe-eosinophilic-asthma
safety
topic biologicals
cost-effectiveness
efficacy
severe-eosinophilic-asthma
safety
description Five biologicals have been approved for severe eosinophilic asthma, a well-recognized phenotype. Systematic reviews (SR) evaluated the efficacy and safety of benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab (alphabetical order) compared to standard of care for severe eosinophilic asthma. PubMed, Embase and Cochrane Library were searched to identify RCTs and health economic evaluations, published in English. Critical and important asthma-related outcomes were evaluated for each of the biologicals. The risk of bias and the certainty of the evidence were assessed using GRADE. 19 RCTs (three RCTs for benralizumab, three RCTs for dupilumab, three RCTs for mepolizumab, five RCTs for omalizumab and five RCTs for reslizumab), including subjects 12 to 75 years old (except for omalizumab including also subjects 6-11 years old), ranging from 12 to 56 weeks were evaluated. All biologicals reduce exacerbation rates with high certainty of evidence: benralizumab incidence rate ratio (IRR) 0.53 (95% CI 0.39 to 0.72), dupilumab (IRR) 0.43 (95% CI 0.32 to 0.59), mepolizumab IRR 0.49 (95% CI 0.38 to 0.66), omalizumab (IRR) 0.56 (95% CI 0.40 to 0.77) and reslizumab (IRR) 0.46 (95% CI 0.37 to 0.58). Benralizumab, dupilumab and mepolizumab reduce the daily dose of oral corticosteroids (OCS) with high certainty of evidence. All evaluated biologicals probably improve asthma control, QoL and FEV1, without reaching the minimal important difference (moderate certainty). Benralizumab, mepolizumab and reslizumab slightly increase drug-related adverse events (AE) and drug-related serious AE (low to very low certainty of evidence). The incremental cost-effectiveness ratio per quality-adjusted life year value is above the willingness to pay threshold for all biologicals (moderate certainty). Potential savings are driven by decrease in hospitalizations, emergency and primary care visits. There is high certainty that all approved biologicals reduce the rate of severe asthma exacerbations and for benralizumab, dupilumab and mepolizumab for reducing OCS. There is moderate certainty for improving asthma control, QoL, FEV1. More data on long-term safety are needed together with more efficacy data in the paediatric population.
publishDate 2020
dc.date.none.fl_str_mv 2020
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=1584
url https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=1584
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv WILEY
publisher.none.fl_str_mv WILEY
dc.source.none.fl_str_mv ALLERGY
ISSN: 01054538
ISSNe: 13989995
reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
instname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
instname_str Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
reponame_str r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
collection r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
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repository.mail.fl_str_mv
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