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).