PMID- 32064642 OWN - NLM STAT- MEDLINE DCOM- 20210514 LR - 20210514 IS - 1398-9995 (Electronic) IS - 0105-4538 (Linking) VI - 75 IP - 5 DP - 2020 May TI - 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. PG - 1043-1057 LID - 10.1111/all.14235 [doi] AB - 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)]. CI - (c) 2020 John Wiley and Sons A/S. Published by John Wiley and Sons Ltd. FAU - Agache, Ioana AU - Agache I AUID- ORCID: 0000-0001-7994-364X AD - Faculty of Medicine, Transylvania University, Brasov, Romania. FAU - Rocha, Claudio AU - Rocha C AD - Iberoamerican Cochrane Centre , Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain. FAU - Beltran, Jessica AU - Beltran J AD - Iberoamerican Cochrane Centre , Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain. FAU - Song, Yang AU - Song Y AD - Iberoamerican Cochrane Centre , Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain. FAU - Posso, Margarita AU - Posso M AD - Iberoamerican Cochrane Centre , Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain. AD - Department of Epidemiology and Evaluation, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain. FAU - Sola, Ivan AU - Sola I AD - Iberoamerican Cochrane Centre , Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain. FAU - Alonso-Coello, Pablo AU - Alonso-Coello P AD - Iberoamerican Cochrane Centre , Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain. AD - CIBER de Epidemiologia y Salud Publica (CIBERESP), Barcelona, Spain. FAU - Akdis, Cezmi AU - Akdis C AUID- ORCID: 0000-0001-8020-019X AD - Swiss Institute of Allergy and Asthma Research (SIAF), University of Zurich, Davos, Switzerland. FAU - Akdis, Mubeccel AU - Akdis M AUID- ORCID: 0000-0003-0554-9943 AD - Swiss Institute of Allergy and Asthma Research (SIAF), University of Zurich, Davos, Switzerland. FAU - Canonica, Giorgio W AU - Canonica GW AD - Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy. FAU - Casale, Thomas AU - Casale T AUID- ORCID: 0000-0002-3149-7377 AD - Division of Allergy and Immunology, University of South Florida Morsani College of Medicine, Tampa, FL, USA. FAU - Chivato, Tomas AU - Chivato T AD - School of Medicine, University CEU San Pablo, Madrid, Spain. FAU - Corren, Jonathan AU - Corren J AD - David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. FAU - Del Giacco, Stefano AU - Del Giacco S AD - Department of Medical Sciences and Public Health, University of Cagliari, Italy, Monserrato. FAU - Eiwegger, Thomas AU - Eiwegger T AUID- ORCID: 0000-0002-2914-7829 AD - Translational Medicine Program, Research Institute, Hospital for Sick Children, Toronto, ON, Canada. AD - Department of Immunology, University of Toronto, Toronto, ON, Canada. AD - Division of Immunology and Allergy, Food Allergy and Anaphylaxis Program, The Hospital for Sick Children, Departments of Paediatrics and Immunology, University of Toronto, Toronto, ON, Canada. FAU - Firinu, Davide AU - Firinu D AUID- ORCID: 0000-0002-5768-391X AD - Department of Medical Sciences and Public Health, University of Cagliari, Italy, Monserrato. FAU - Gern, James E AU - Gern JE AD - Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. FAU - Hamelmann, Eckard AU - Hamelmann E AUID- ORCID: 0000-0002-2996-8248 AD - Klinik fur Kinder- und Jugendmedizin Kinderzentrum Bethel, Bielefeld, Germany. FAU - Hanania, Nicola AU - Hanania N AD - Section of Pulmonary, Critical Care and Sleep Medicine, Baylor College of Medicine, Houston, Texas, USA. FAU - Makela, Mika AU - Makela M AD - Skin and Allergy Hospital, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. FAU - Martin, Irene Hernandez AU - Martin IH AD - Department of Allergy, Hospital Universitario La Paz, Madrid, Spain. FAU - Nair, Parameswaran AU - Nair P AUID- ORCID: 0000-0002-1041-9492 AD - Division of Respirology, Department of Medicine, McMaster University, Hamilton, ON, Canada. AD - Firestone Institute for Respiratory Health, St Joseph's Healthcare, Hamilton, ON, Canada. FAU - O'Mahony, Liam AU - O'Mahony L AUID- ORCID: 0000-0003-4705-3583 AD - Departments of Medicine and Microbiology, APC Microbiome Ireland, University College Cork, Cork, Ireland. FAU - Papadopoulos, Nikolaos G AU - Papadopoulos NG AUID- ORCID: 0000-0002-4448-3468 AD - Division of Infection, Immunity & Respiratory Medicine, University of Manchester, Manchester, UK. AD - Allergy Department, 2nd Pediatric Clinic, National Kapodistrian University of Athens, Athens, Greece. FAU - Papi, Alberto AU - Papi A AD - Research Center on Asthma and COPD, Department of Medical Sciences, University of Ferrara, Ferrara, Italy. FAU - Park, Hae-Sim AU - Park HS AUID- ORCID: 0000-0003-2614-0303 AD - Department of Allergy and Clinical Immunology, Ajou University, Suwon, South Korea. FAU - Perez de Llano, Luis AU - Perez de Llano L AUID- ORCID: 0000-0003-2652-6847 AD - Department of Respiratory Medicine, Hospital Lucus Augusti, Lugo, Spain. FAU - Quirce, Santiago AU - Quirce S AD - Department of Allergy, La Paz University Hospital, IdiPAZ, CIBER of Respiratory Diseases (CIBERES), Universidad Autonoma de Madrid, Madrid, Spain. FAU - Sastre, Joaquin AU - Sastre J AUID- ORCID: 0000-0003-4689-6837 AD - Universidad Autonoma de Madrid Facultad de Medicina, Madrid, Spain. FAU - Shamji, Mohamed AU - Shamji M AUID- ORCID: 0000-0003-3425-3463 AD - Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation, Repair, Development, National Heart and Lung Institute, London, UK. AD - Imperial College NIHR Biomedical Research Centre, UK Centre in Allergic Mechanisms of Asthma, London, UK. FAU - Schwarze, Jurgen AU - Schwarze J AD - Centre for Inflammation Research, Child Life and Health, The University of Edinburgh, Edinburgh, UK. FAU - Canelo-Aybar, Carlos AU - Canelo-Aybar C AD - Iberoamerican Cochrane Centre , Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain. AD - Swiss Institute of Allergy and Asthma Research (SIAF), University of Zurich, Davos, Switzerland. FAU - Palomares, Oscar AU - Palomares O AUID- ORCID: 0000-0003-4516-0369 AD - Department of Biochemistry and Molecular Biology, Chemistry School, Complutense University of Madrid, Madrid, Spain. FAU - Jutel, Marek AU - Jutel M AD - University of Wroclaw, Department of Clinical Immunology, Wroclaw, Poland. AD - "ALL-MED" Medical Research Institute, Wroclaw, Poland. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Systematic Review PL - Denmark TA - Allergy JT - Allergy JID - 7804028 RN - 0 (Anti-Asthmatic Agents) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Biological Products) RN - 2P471X1Z11 (Omalizumab) RN - 420K487FSG (dupilumab) RN - 71492GE1FX (benralizumab) SB - IM MH - *Anti-Asthmatic Agents/therapeutic use MH - Antibodies, Monoclonal, Humanized MH - *Asthma/drug therapy MH - *Biological Products/adverse effects MH - Child MH - Humans MH - Omalizumab/adverse effects MH - Quality of Life OTO - NOTNLM OT - benralizumab OT - dupilumab OT - exacerbations OT - omalizumab OT - severe allergic asthma EDAT- 2020/02/18 06:00 MHDA- 2021/05/15 06:00 CRDT- 2020/02/18 06:00 PHST- 2020/02/04 00:00 [received] PHST- 2020/02/11 00:00 [accepted] PHST- 2020/02/18 06:00 [pubmed] PHST- 2021/05/15 06:00 [medline] PHST- 2020/02/18 06:00 [entrez] AID - 10.1111/all.14235 [doi] PST - ppublish SO - Allergy. 2020 May;75(5):1043-1057. doi: 10.1111/all.14235.