Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma
Loading...
Files
Accepted Version
Supplementary Information
Date
2020-02-08
Authors
Agache, Ioana
Beltran, Jessica
Akdis, Cezmi
Akdis, Mubeccel
Canelo-Aybar, Carlos
Canonica, Walter
Casale, Thomas
Chivato, Tomas
Corren, Jonathan
Del Giacco, Stefano
Journal Title
Journal ISSN
Volume Title
Publisher
John Wiley & Sons, Inc.
Published Version
Abstract
Five 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.
Description
Keywords
Severe asthma , Cost-effectiveness , Eosinophilic asthma , Exacerbations , Benralizumab , Dupilumab , Mepolizumab , Omalizumab , Reslizumab
Citation
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
Link to publisher’s version
Copyright
© 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.