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

  • Ioana Agache
    Faculty of Medicine Transylvania University Brasov Romania
  • Claudio Rocha
    Iberoamerican Cochrane Centre Department of Clinical Epidemiology and Public Health Biomedical Research Institute Sant Pau (IIB Sant Pau) Barcelona Spain
  • Jessica Beltran
    Iberoamerican Cochrane Centre Department of Clinical Epidemiology and Public Health Biomedical Research Institute Sant Pau (IIB Sant Pau) Barcelona Spain
  • Yang Song
    Iberoamerican Cochrane Centre Department of Clinical Epidemiology and Public Health Biomedical Research Institute Sant Pau (IIB Sant Pau) Barcelona Spain
  • Margarita Posso
    Iberoamerican Cochrane Centre Department of Clinical Epidemiology and Public Health Biomedical Research Institute Sant Pau (IIB Sant Pau) Barcelona Spain
  • Ivan Solà
    Iberoamerican Cochrane Centre Department of Clinical Epidemiology and Public Health Biomedical Research Institute Sant Pau (IIB Sant Pau) Barcelona Spain
  • Pablo Alonso‐Coello
    Iberoamerican Cochrane Centre Department of Clinical Epidemiology and Public Health Biomedical Research Institute Sant Pau (IIB Sant Pau) Barcelona Spain
  • Cezmi Akdis
    Swiss Institute of Allergy and Asthma Research (SIAF) University of Zurich Davos Switzerland
  • Mubeccel Akdis
    Swiss Institute of Allergy and Asthma Research (SIAF) University of Zurich Davos Switzerland
  • Giorgio W. Canonica
    Personalized Medicine, Asthma and Allergy Humanitas Clinical and Research Center IRCCS Rozzano Italy
  • Thomas Casale
    Division of Allergy and Immunology University of South Florida Morsani College of Medicine Tampa FL USA
  • Tomas Chivato
    School of Medicine University CEU San Pablo Madrid Spain
  • Jonathan Corren
    David Geffen School of Medicine at UCLA Los Angeles CA USA
  • Stefano Del Giacco
    Department of Medical Sciences and Public Health University of Cagliari Italy Monserrato
  • Thomas Eiwegger
    Translational Medicine Program, Research Institute Hospital for Sick Children Toronto ON Canada
  • Davide Firinu
    Department of Medical Sciences and Public Health University of Cagliari Italy Monserrato
  • James E. Gern
    Department of Pediatrics University of Wisconsin School of Medicine and Public Health Madison WI USA
  • Eckard Hamelmann
    Klinik für Kinder‐ und Jugendmedizin Kinderzentrum Bethel Bielefeld Germany
  • Nicola Hanania
    Section of Pulmonary, Critical Care and Sleep Medicine Baylor College of Medicine Houston Texas USA
  • Mika Mäkelä
    Skin and Allergy Hospital Helsinki University Hospital and University of Helsinki Helsinki Finland
  • Irene Hernández Martín
    Department of Allergy Hospital Universitario La Paz Madrid Spain
  • Parameswaran Nair
    Division of Respirology Department of Medicine McMaster University Hamilton ON Canada
  • Liam O'Mahony
    Departments of Medicine and Microbiology APC Microbiome Ireland University College Cork Cork Ireland
  • Nikolaos G. Papadopoulos
    Division of Infection Immunity & Respiratory Medicine University of Manchester Manchester UK
  • Alberto Papi
    Research Center on Asthma and COPD Department of Medical Sciences University of Ferrara Ferrara Italy
  • Hae‐Sim Park
    Department of Allergy and Clinical Immunology Ajou University Suwon South Korea
  • Luis Pérez de Llano
    Department of Respiratory Medicine Hospital Lucus Augusti Lugo Spain
  • Santiago Quirce
    Department of Allergy La Paz University Hospital IdiPAZ CIBER of Respiratory Diseases (CIBERES) Universidad Autónoma de Madrid Madrid Spain
  • Joaquin Sastre
    Universidad Autónoma de Madrid Facultad de Medicina Madrid Spain
  • Mohamed Shamji
    Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation Repair, Development National Heart and Lung Institute London UK
  • Jurgen Schwarze
    Centre for Inflammation Research Child Life and Health The University of Edinburgh Edinburgh UK
  • Carlos Canelo‐Aybar
    Iberoamerican Cochrane Centre Department of Clinical Epidemiology and Public Health Biomedical Research Institute Sant Pau (IIB Sant Pau) Barcelona Spain
  • Oscar Palomares
    Department of Biochemistry and Molecular Biology Chemistry School Complutense University of Madrid Madrid Spain
  • Marek Jutel
    Department of Clinical Immunology Wroclaw Medical University Wroclaw Poland

抄録

<jats:title>Abstract</jats:title><jats:p>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)].</jats:p>

収録刊行物

  • Allergy

    Allergy 75 (5), 1043-1057, 2020-05

    Wiley

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