Title
Efficacy and safety of treatment with biologicals (benralizumab, dupilumab and omalizumab) for severe allergic asthma: A systematic review for the EAACI Guidelines - recommendations on the use of biologicals in severe asthma
Date Issued
01 May 2020
Access level
open access
Resource Type
journal article
Author(s)
Agache I.
Rocha C.
Beltran J.
Song Y.
Posso M.
Solà I.
Alonso-Coello P.
Akdis C.
Akdis M.
Canonica G.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.
Quirce S.
Sastre J.
Shamji M.
Schwarze J.
Palomares O.
Jutel M.
Instituto de Investigación Biomédica Sant Pau
Publisher(s)
Blackwell Publishing Ltd
Abstract
Allergic asthma is a frequent asthma phenotype. Both IgE and type 2 cytokines are increased, with some degree of overlap with other phenotypes. Systematic reviews assessed the efficacy and safety of benralizumab, dupilumab and omalizumab (alphabetical order) vs standard of care for patients with uncontrolled severe allergic 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. The risk of bias and the certainty of the evidence were assessed using GRADE. All three biologicals reduced with high certainty the annualized asthma exacerbation rate: benralizumab incidence rate ratios (IRR) 0.63 (95% CI 0.50 − 0.81); dupilumab IRR 0.58 (95%CI 0.47 − 0.73); and omalizumab IRR 0.56 (95%CI 0.42 − 0.73). Benralizumab and dupilumab improved asthma control with high certainty and omalizumab with moderate certainty; however, none reached the minimal important difference (MID). Both benralizumab and omalizumab improved QoL with high certainty, but only omalizumab reached the MID. Omalizumab enabled ICS dose reduction with high certainty. Benralizumab and omalizumab showed an increase in drug-related adverse events (AEs) with low to moderate certainty. All three biologicals had moderate certainty for an ICER/QALY value above the willingness to pay threshold. There was high certainty that in children 6-12 years old omalizumab decreased the annualized exacerbation rate [IRR 0.57 (95%CI 0.45-0.72)], improved QoL [relative risk 1.43 (95%CI 1.12 −1.83)], reduced ICS [mean difference (MD) −0.45 (95% CI −0.58 to −0.32)] and rescue medication use [MD −0.41 (95%CI −0.66 to −0.15)].
Start page
1043
End page
1057
Volume
75
Issue
5
Language
English
OCDE Knowledge area
Inmunología
Subjects
Scopus EID
2-s2.0-85084441070
PubMed ID
Source
Allergy: European Journal of Allergy and Clinical Immunology
ISSN of the container
01054538
Source funding
Amgen
Sponsor(s)
IA serves as associate editor of Allergy. CR, JB, YS, MP, IS and PA‐C have received funding from EAACI. CA and MA report grants from Allergopharma, Idorsia, Swiss National Science Foundation, Christine Kühne‐Center for Allergy Research and Education, European Commission Horizon 2020 Framework Programme, Cure, Novartis Research Institutes, AstraZeneca, Scibase, and CA is also on the Sanofi/Regeneron advisory board. T Casale reports grants and/or personal fees from Genentech, Novartis, Sanofi Regeneron, GSK and Amgen. JC declares grants or personal fees from AZ, Genentech/Roche, Novartis, Optinose, Sanofi, Stallergenes and TEVA. SG reports personal fees from AstraZeneca, GSK and Novartis. TE has received grants or other from DBV, Innovation Fund Denmark, Regeneron, the Allergy and Anaphylaxis Program SickKids; serves as associate editor for Allergy and in the local advisory board of ALK. JG reports personal fees from Regeneron, Ena Therapeutics and MedImmune/AstraZeneca, and stock options from Meissa Vaccines Inc In addition, JG has a pending patents on Methods of Propagating Rhinovirus C in Previously Unsusceptible Cell Lines and on Adapted Rhinovirus C. NH reports funding, honoraria or personal fees from GSK, AstraZeneca, Boehringer Ingelheim, Novartis and Sanofi Genzyme, Regeneron, Genentech, Sunovion and Mylan. PN reports grants and/or personal fees from AZ, Novartis, Teva, Sanofi, Roche, Novartis, Merck and Equillium. LOM reports grants from GSK and personal fees from AHL. NGP reports personal fees from Novartis, Nutricia, HAL, Menarini/Faes Farma, Sanofi, Mylan/Meda, Biomay, AstraZeneca, GSK, MSD, Asit Biotech, Boehringer Ingelheim, and grants from Gerolymatos International SA and Capricare. AP has received grants, personal fees, nonfinancial support or other from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, TEVA, Mundipharma, Zambon, Novartis, Menarini, Sanofi/Regeneron, Roche, Fondazione Maugeri, Fondazione Chiesi and Edmond Pharma. LP reports grants, personal fees or nonfinancial support from Novartis, AstraZeneca, GSK, TEVA, Boehringer Ingelheim, Chiesi, Sanofi, Menarini, Mundipharma, Esteve and ROVI. SQ reports personal fees and nonfinancial support from GSK, AZ, Sanofi, Novartis, Mundipharma, Teva and Allergy Therapeutics. JSastre declares personal fees and nonfinancial support from Novartis, GSK, AstraZeneca, Sanofi and Mundipharma. MS reports personal fees or research funding from ASIT Biotech.sa, Allergy Therapeutics, ALK, Regeneron, Merck, Immune Tolerance Network, Leti Laboratorios and Allergopharma. CC‐A reports funding from EAACI. OP received research grants from Inmunotek SL and Novartis; received fees for giving scientific lectures from Allergy Therapeutics, Amgen, AstraZeneca, Diater, GSK, Inmunotek S.L, Novartis, Sanofi Genzyme and Stallergenes; and participated in advisory boards from Novartis and Sanofi Genzyme. MJ reports personal fees from ALK‐Abello, Allergopharma, Stallergenes, Anergis, Allergy Therapeutics, Circassia, Leti, Biomay, HAL, AstraZeneca, GSK, Novartis, Teva, Vectura, UCB, Takeda, Roche, Janssen, MedImmune and Chiesi. All other authors have no conflict of interest within the scope of the submitted work.
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