PMID- 32154939 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 dupilumab for severe asthma: A systematic review of the EAACI guidelines-Recommendations on the use of biologicals in severe asthma. PG - 1058-1068 LID - 10.1111/all.14268 [doi] AB - Dupilumab, a fully human monoclonal antibody against interleukin-4 receptor alpha, is approved as add-on maintenance treatment for inadequately controlled type 2 severe asthma. This systematic review evaluated the efficacy, safety and economic impact of dupilumab compared to standard of care for uncontrolled severe asthma. PubMed, EMBASE and Cochrane Library were searched for RCTs and health economic evaluations. Critical and important asthma-related outcomes were evaluated. The risk of bias and the certainty of the evidence were assessed using GRADE. Three RCTs including 2735 subjects >12 years old and 24-52 weeks of follow-up were included. Dupilumab reduced with high certainty severe asthma exacerbations (Incidence rate ratio 0.51; 95% CI 0.45-0.59) and the percentage use of oral corticosteroid use (mean difference (MD) -28.2 mg/d; 95% CI -40.7 to -15.7). Asthma control (ACQ-5), quality of life (AQLQ) and rescue medication use [puffs/d] improved, without reaching the minimal important clinical difference: ACQ-5 MD -0.28 (95% CI -0.39 to -0.17); AQLQ MD +0.28 (95% CI 0.20-0.37); and rescue medication MD -0.35 (95% CI -0.73 to +0.02). FEV(1) increased (MD +0.15; 95% CI +0.11 to +0.18) (moderate certainty). There was an increased rate of dupilumab-related adverse events (AEs) (moderate certainty) and of drug-related serious AEs (low certainty). The incremental cost-effectiveness ratio of dupilumab versus standard therapy was 464 000$/QALY (moderate certainty). More data on long-term safety are needed both for children and for adults, together with more efficacy data in the paediatric population. CI - (c) 2020 EAACI and 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 - 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 - 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 - 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 - Steiner, Corinna AU - Steiner C 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. AD - Christine Kuhne-Center for Allergy Research and Education, 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. AD - Christine Kuhne-Center for Allergy Research and Education, Davos, Switzerland. FAU - Canonica, Giorgio Walter 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 AUID- ORCID: 0000-0002-4517-1749 AD - Department of Medical Sciences and Public Health, University of Cagliari, Monserrato, Italy. 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, Departments of Paediatrics and Immunology, The Hospital for Sick Children, 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, Monserrato, Italy. FAU - Gern, James E AU - Gern JE AUID- ORCID: 0000-0002-6667-4708 AD - Department of Pediatrics, School of Medicine and Public Health, University of Wisconsin, 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, TX, 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 - Department of Medical Sciences, Research Center on Asthma and COPD, 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 - Facultad de Medicina, Universidad Autonoma de Madrid, Madrid, Spain. FAU - Shamji, Mohamed AU - Shamji M AUID- ORCID: 0000-0003-3425-3463 AD - Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation, National Heart and Lung Institute, London, UK. AD - Imperial College NIHR Biomedical Research Centre, Asthma 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 - CIBER de Epidemiologia y Salud Publica (CIBERESP), Barcelona, Spain. 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 - Department of Clinical Immunology, University of Wroclaw, 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 DEP - 20200401 PL - Denmark TA - Allergy JT - Allergy JID - 7804028 RN - 0 (Anti-Asthmatic Agents) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Biological Products) RN - 420K487FSG (dupilumab) SB - IM MH - Adult MH - *Anti-Asthmatic Agents/adverse effects MH - Antibodies, Monoclonal, Humanized MH - *Asthma/drug therapy MH - *Biological Products/therapeutic use MH - Child MH - Humans MH - Quality of Life OTO - NOTNLM OT - cost-effectiveness OT - dupilumab OT - exacerbations OT - oral corticosteroids OT - severe asthma EDAT- 2020/03/11 06:00 MHDA- 2021/05/15 06:00 CRDT- 2020/03/11 06:00 PHST- 2020/02/18 00:00 [received] PHST- 2020/02/24 00:00 [accepted] PHST- 2020/03/11 06:00 [pubmed] PHST- 2021/05/15 06:00 [medline] PHST- 2020/03/11 06:00 [entrez] AID - 10.1111/all.14268 [doi] PST - ppublish SO - Allergy. 2020 May;75(5):1058-1068. doi: 10.1111/all.14268. Epub 2020 Apr 1.