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Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines |
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| Authors: | Ioana Agache Claudio Rocha Ana Pereira Yang Song Pablo Alonso-Coello Ivan Solà Jessica Beltran Margarita Posso Cezmi A. Akdis Mubeccel Akdis Knut Brockow Tomas Chivato Stefano del Giacco Thomas Eiwegger Kilian Eyerich Ana Giménez-Arnau Jan Gutermuth Emma Guttman-Yassky Marcus Maurer Graham Ogg Peck Ong Liam O’Mahony Jürgen Schwarze Thomas Werfel Carlos Canelo-Aybar Oscar Palomares Marek Jutel |
| Affiliation: | 1. Faculty of Medicine, Transylvania University, Brasov, Romania;2. Iberoamerican Cochrane Centre - Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain;3. Iberoamerican Cochrane Centre - Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain CIBER de Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain;4. Department of Epidemiology and Evaluation, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain;5. Swiss Institute of Allergy and Asthma Research (SIAF), University of Zurich, 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, Cagliari, Italy;9. Translational Medicine Program, Research Institute, Hospital for Sick Children, Toronto, ON, Canada;10. Department of Dermatology and Allergy Biederstein, Technical University of Munich, Munich, Germany;11. Department of Dermatology, Hospital del Mar- Institut Mar d'Investigacions Mèdiques, Universitat Autònoma de Barcelona, Barcelona, Spain;12. Department of Dermatology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel (VUB), Brussels, Belgium;13. Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA;14. Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany;15. MRC Human Immunology Unit, Department of Medicine, Weatherall Institute of Molecular Medicine, University of Oxford, Radcliffe, Oxford, UK;16. Keck School of Medicine, University of Southern California, Los Angeles, CA, USA;17. Departments of Medicine and Microbiology, APC Microbiome Ireland, University College Cork, Cork, Ireland;18. Centre for Inflammation Research, Child Life and Health, The University of Edinburgh, Edinburgh, UK;19. Division of Immunodermatology and Allergy Research, Department of Dermatology and Allergy, Hannover Medical School, Hannover, Germany;20. Department of Biochemistry and Molecular Biology, Chemistry School, Complutense University of Madrid, Madrid, Spain;21. Department of Clinical Immunology, Wroclaw Medical University, Wroclaw, Poland All-MED Medical Research Institute, Wroclaw, Poland |
| Abstract: | This systematic review evaluates the efficacy and safety of omalizumab for chronic spontaneous urticaria (CSU). PubMed, Embase, and Cochrane Library were searched for RCTs. Critical and important CSU-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE. Ten RCTs including 1620 subjects aged 12 to 75 years old treated with omalizumab for 16 to 40 weeks were evaluated. Omalizumab 150 mg does not result in clinically meaningful improvement (high certainty) of the urticaria activity score (UAS)7 (mean difference (MD) −5; 95%CI −7.75 to −2.25), and the itch severity score (ISS)7 (MD −2.15; 95% CI −3.2 to −1.1) does not increase (moderate certainty) quality of life (QoL) (Dermatology Life Quality Index (DLQI); MD −2.01; 95%CI −3.22 to −0.81) and decreases (moderate certainty) rescue medication use (MD −1.68; 95%CI −2.95 to −0.4). Omalizumab 300 mg results in clinically meaningful improvements (moderate certainty) of the UAS7 (MD −11.05; 95%CI −12.87 to −9.24), the ISS7 (MD −4.45; 95%CI −5.39 to −3.51), and QoL (high certainty) (DLQI; MD −4.03; 95% CI −5.56 to −2.5) and decreases (moderate certainty) rescue medication use (MD −2.04; 95%CI −3.19 to −0.88) and drug-related serious AEs (RR 0.77; 95%CI 0.20 to 2.91). |
| Keywords: | chronic idiopathic urticaria chronic spontaneous urticaria itch severity score omalizumab urticaria activity score |