Affiliations
1Transylvania University, Faculty of Medicine, Brasov, Romania
2Iberoamerican Cochrane Centre - Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain
3 Department of Epidemiology and Evaluation, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.
4CIBER de Epidemiología y Salud Pública (CIBERESP), Spain.
5 Swiss Institute of Allergy and Asthma Research (SIAF), University of Zurich, Davos, Switzerland; Christine Kühne-Center for Allergy Research and Education, Davos Switzerland
6 Department of Dermatology and Allergology Biederstein, Technical University of Munich, Munich, Germany
7 School of Medicine University CEU San Pablo, Madrid, Spain
8 Department of Medical Sciences and Public Health, University of Cagliari, Italy
9 Translational Medicine Program, Research Institute, Hospital for Sick Children, Toronto, ON, Canada
10 Department of Immunology, University of Toronto, Toronto, ON, Canada
11 Division of Immunology and Allergy, Food Allergy and Anaphylaxis Program, The Hospital for Sick Children, Departments of Paediatrics and Immunology, University of Toronto, Toronto, Canada
12 Department of Dermatology and Allergy Biederstein, Technical University of Munich, Munich, Germany
13 Department of Dermatology, Hospital del Mar- Institut Mar d’Investigacions Mèdiques, Universitat Autònoma de Barcelona, Spain
14 Department of Dermatology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel (VUB), Brussels, Belgium
15 Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, USA
16 Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Germany
17 MRC Human Immunology Unit, MRC Weatherall Institute of Molecular Medicine, Oxford NIHR Biomedical Research Centre, Radcliffe Department of Medicine, University of Oxford,UK
18 Division of Clinical Immunology & Allergy, Children’s Hospital Los Angeles, Keck School of Medicine, University of Southern California, USA
19 Departments of Medicine and Microbiology, APC Microbiome Ireland, University College Cork, Cork, Ireland
20 Centre for Inflammation Research, Child Life and Health, The University of Edinburgh, Edinburgh, United Kingdom
21Division of Immunodermatology and Allergy Research, Department of Dermatology and Allergy, Hannover Medical School, Hannover, Germany
22 Department of Biochemistry and Molecular Biology, Chemistry School, Complutense University of Madrid, Spain
23University of Wroclaw, Department of Clinical Immunology, Wroclaw, Poland
24“ALL-MED” Medical Research Institute, Wroclaw, Poland

Abstract (200 words)

This systematic review evaluates the efficacy, safety and economic impact of dupilumab compared to standard of care for uncontrolled moderate-to-severe atopic dermatitis (AD).
Pubmed, EMBASE and Cochrane Library were searched for RCTs and health economic evaluations. Critical and important AD-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE.
Seven RCTs including 1845 subjects > 12 years treated with dupilumab 16 to 52 weeks were evaluated. For adults there is high certainty that dupilumab decreases SCORAD (MD -30,72; 95%CI -34,65% to -26,79%) and EASI-75 (RR 3.09; 95%CI 2.45 to 3.89), pruritus (RR 2.96; 95%CI 2.37 to 3.70), rescue medication (RR 3.46; 95%CI 2.79 to 4.30), sleep disturbance (MD -7.29; 95%CI -8.23 to -6.35), anxiety/depression (MD -3.08; 95% CI -4.41 to -1.75) and improves quality of life (MD -4.80; 95% CI -5.55 to -4.06). The efficacy for adolescents is similar. Dupilumab-related adverse events (AEs) slightly increase (low certainty). The evidence for dupilumab-related serious AE is uncertain. The incremental cost-effectiveness ratio ranged from 28,500 £ (low certainty) to 124,541 US$ (moderate certainty). More data on long term safety are needed both for children and adults, together with more efficacy data in the paediatric population.
Registration : PROSPERO (CRD42020153645).