Please use this identifier to cite or link to this item: http://hdl.handle.net/10637/15129

Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI Guidelines - recommendations on the use of biologicals in severe asthma.

Title: Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI Guidelines - recommendations on the use of biologicals in severe asthma.
Authors : Agache, Ioana
Beltran, Jessica
Akdis, Cezmi A.
Akdis, Mubeccel
Canelo Aybar, C.
Canonica, Giorgio Walter
Casale, Thomas
Chivato Pérez, Tomás
Corren, Jonathan
Giacco, Stefano del
Eiwegger, Thomas
Firinu, Davide
Gern, James E.
Hamelmann, Eckard
Hanania, Nicola
Mäkelä, Mika
Hernández Martín, Irene
O'Mahony, Liam
Papi, Alberto
Park, Hae-Sim
Pérez de Llano, Luis
Rocha, Claudio
Quirce, Santiago
Sastre, Joaquín
Shamji, Mohamed
Song, Yang
Steiner, Corinna
Schwarze, Jürgen
Alonso Coello, Pablo
Palomares, Oscar
Jutel, Marek
Keywords: BiologicalsCost-effectivenessEfficacySevere-eosinophilic-asthmaSafety
Publisher: Wiley
Citation: Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI Guidelines - recommendations on the use of biologicals in severe asthma. Allergy. 2020;75:1023– 1042. https ://doi.org/10.1111/all.14221
Abstract: 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 drugrelated 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.
URI: http://hdl.handle.net/10637/15129
Rights : http://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
ISSN: 1398-9995
Issue Date: 2020
Center : Universidad San Pablo-CEU
Appears in Collections:Medicina





Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.