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

  • Ioana Agache
    Faculty of Medicine Transylvania University Brasov Romania
  • Jessica Beltran
    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
  • Carlos Canelo‐Aybar
    Iberoamerican Cochrane Centre Department of Clinical Epidemiology and Public Health Biomedical Research Institute Sant Pau (IIB Sant Pau) Barcelona Spain
  • Giorgio Walter 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 Cagliari Italy
  • 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 Cagliari Italy
  • 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 TX 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 and 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 Korea
  • Luis Pérez de Llano
    Department of Respiratory Medicine Hospital Lucus Augusti Lugo Spain
  • Margarita Posso
    Iberoamerican Cochrane Centre Department of Clinical Epidemiology and Public Health Biomedical Research Institute Sant Pau (IIB Sant Pau) Barcelona Spain
  • Claudio Rocha
    Iberoamerican Cochrane Centre Department of Clinical Epidemiology and Public Health Biomedical Research Institute Sant Pau (IIB Sant Pau) Barcelona 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
  • Yang Song
    Iberoamerican Cochrane Centre Department of Clinical Epidemiology and Public Health Biomedical Research Institute Sant Pau (IIB Sant Pau) Barcelona Spain
  • Corinna Steiner
    Iberoamerican Cochrane Centre Department of Clinical Epidemiology and Public Health Biomedical Research Institute Sant Pau (IIB Sant Pau) Barcelona Spain
  • Jurgen Schwarze
    Centre for Inflammation Research, Child Life and Health The University of Edinburgh Edinburgh UK
  • Pablo Alonso‐Coello
    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>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 FEV<jats:sub>1</jats:sub>, 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 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, FEV<jats:sub>1</jats:sub>. More data on long‐term safety are needed together with more efficacy data in the paediatric population.</jats:p>

収録刊行物

  • Allergy

    Allergy 75 (5), 1023-1042, 2020-02-24

    Wiley

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