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

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dc.contributor.authorAgache, Ioana
dc.contributor.authorBeltran, Jessica
dc.contributor.authorAkdis, Cezmi
dc.contributor.authorAkdis, Mubeccel
dc.contributor.authorCanelo-Aybar, Carlos
dc.contributor.authorCanonica, Walter
dc.contributor.authorCasale, Thomas
dc.contributor.authorChivato, Tomas
dc.contributor.authorCorren, Jonathan
dc.contributor.authorDel Giacco, Stefano
dc.contributor.authorEiwegger, Thomas
dc.contributor.authorFirinu, Davide
dc.contributor.authorGern, James E.
dc.contributor.authorHamelmann, Eckard
dc.contributor.authorHanania, Nicola
dc.contributor.authorMäkelä, Mika
dc.contributor.authorMartín, Irene Hernández
dc.contributor.authorNair, Parameswaran
dc.contributor.authorO'Mahony, Liam
dc.contributor.authorPapadopoulos, Nikolaos G.
dc.contributor.authorPapi, Alberto
dc.contributor.authorPark, Hae-Sim
dc.contributor.authorPérez de Llano, Luis
dc.contributor.authorPosso, Margarita
dc.contributor.authorRocha, Claudio
dc.contributor.authorQuirce, Santiago
dc.contributor.authorSastre, Joaquin
dc.contributor.authorShamji, Mohamed
dc.contributor.authorSong, Yang
dc.contributor.authorSteiner, Corinna
dc.contributor.authorSchwarze, Jurgen
dc.contributor.authorAlonso-Coello, Pablo
dc.contributor.authorPalomares, Oscar
dc.contributor.authorJutel, Marek
dc.date.accessioned2020-03-10T12:34:45Z
dc.date.available2020-03-10T12:34:45Z
dc.date.issued2020-02-08
dc.date.updated2020-02-19T11:22:22Z
dc.description.abstractFive biologicals have been approved for severe eosinophilic asthma, a well-recognised 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 (3 RCTs for benralizumab, 3 RCTs for dupilumab, 3 RCTs for mepolizumab, 4 RCTs for omalizumab, and 5 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 rate ratio (RR) 0.53 (95% CI 0.39 to 0.72), dupilumab RR 0.43 (95% CI 0.32 to 0.59), mepolizumab RR 0.49 (95% CI 0.38 to 0.66), omalizumab RR 0.56 (95% CI 0.40 to 0.77), and reslizumab RR 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-years value is above the willingness to pay threshold for all biologicals (moderate certainty). Potential savings are driven by decrease in hospitalisations, 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 and cost-effectiveness. More data on long term safety are needed together with more efficacy data in the paediatric population.en
dc.description.statusPeer revieweden
dc.description.versionAccepted Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationAgache, I., Beltran, J., Akdis, C., Akdis, M., Canelo-Aybar, C., Canonica, W., Casale, T., Chivato, T., Corren, J., Del Giacco, S., Eiwegger, T., Firinu, D., Gern, J. E., Hamelmann, E., Hanania, N., Mäkelä, M., Martín, I. H., Nair, P., O'Mahony, L., Papadopoulos, N. G., Papi, A., Park, H.-S., Pérez de Llano, L., Posso, M., Rocha, C., Quirce, S., Sastre, J., Shamji, M., Song, Y., Steiner, C., Schwarze, J., Alonso-Coello, P., Palomares, O. and Jutel, M. (2020) 'Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma', Allergy. doi: 10.1111/all.14221en
dc.identifier.doi10.1111/all.14221en
dc.identifier.eissn1398-9995
dc.identifier.issn0105-4538
dc.identifier.journaltitleAllergyen
dc.identifier.urihttps://hdl.handle.net/10468/9742
dc.language.isoenen
dc.publisherJohn Wiley & Sons, Inc.en
dc.relation.urihttps://onlinelibrary.wiley.com/doi/abs/10.1111/all.14221
dc.rights© 2020, EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd. This is the peer reviewed version of the following article: Agache, I., Beltran, J., Akdis, C., Akdis, M., Canelo-Aybar, C., Canonica, W., Casale, T., Chivato, T., Corren, J., Del Giacco, S., Eiwegger, T., Firinu, D., Gern, J. E., Hamelmann, E., Hanania, N., Mäkelä, M., Martín, I. H., Nair, P., O'Mahony, L., Papadopoulos, N. G., Papi, A., Park, H.-S.. Pérez de Llano, L., Posso, M., Rocha, C., Quirce, S., Sastre, J., Shamji, M., Song, Y., Steiner, C., Schwarze, J., Alonso-Coello, P., Palomares, O. and Jutel, M. (2020) 'Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma', Allergy, doi: 10.1111/all.14221, which has been published in final form at https://doi.org/10.1111/all.14221. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions.en
dc.subjectSevere asthmaen
dc.subjectCost-effectivenessen
dc.subjectEosinophilic asthmaen
dc.subjectExacerbationsen
dc.subjectBenralizumaben
dc.subjectDupilumaben
dc.subjectMepolizumaben
dc.subjectOmalizumaben
dc.subjectReslizumaben
dc.titleEfficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthmaen
dc.typeArticle (peer-reviewed)en
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