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Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria- a systematic review for the EAACI Biologicals Guidelines
  • +23
  • Ioana Agache,
  • Claudio Rocha,
  • Yang Song,
  • Pablo Alonso-Coello,
  • Ivan Sola,
  • Jessica Beltran,
  • Margarita Posso,
  • Cezmi Akdis,
  • Mubeccel Akdis,
  • Knut Brockow,
  • T. Chivato,
  • Stefano R. Del Giacco,
  • Thomas Eiwegger,
  • Kilian Eyerich,
  • Ana Giménez Arnau,
  • Jan Gutermuth,
  • Emma Guttmann-Yassky,
  • Marcus MaurerOrcid,
  • Graham Ogg,
  • Peck Ong,
  • Liam O'Mahony,
  • Jürgen Schwarze,
  • Thomas Werfel,
  • Carlos Canelo-Aybar,
  • Oscar Palomares,
  • Marek Jutel
Ioana Agache
Transylvania University of Brasov
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Claudio Rocha
Biomedical Research Institute Sant Pau
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Yang Song
Biomedical Research Institute Sant Pau
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Pablo Alonso-Coello
Hospital Sant Pau
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Ivan Sola
Biomedical Research Institute
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Jessica Beltran
Biomedical Research Institute Sant Pau
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Margarita Posso
IMIM
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Cezmi Akdis
University of Zurich
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Mubeccel Akdis
University of Zürich
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Knut Brockow
Technical University of Munich
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T. Chivato
Univ CEU San Pablo
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Stefano R. Del Giacco
University of Cagliari Faculty of Medicine
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Thomas Eiwegger
The Hospital for Sick Children
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Kilian Eyerich
TUM
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Ana Giménez Arnau
Hospital del Mar. Institut Mar d´Investigacions Mediques
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Jan Gutermuth
Universitair Ziekenhuis Brussel
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Emma Guttmann-Yassky
Rockefeller University
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Marcus Maurer
Orcid
Charité Universitätsmedizin Berlin
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Graham Ogg
University of Oxford
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Peck Ong
Childrens Hospital Los Angeles, University of Southern California Keck School of Medicine
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Liam O'Mahony
University College Cork National University of Ireland
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Jürgen Schwarze
University of Edinburgh, Edinburgh
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Thomas Werfel
Hannover Medical School
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Carlos Canelo-Aybar
Biomedical Research Institute Sant Pau
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Oscar Palomares
Complutense University of Madrid
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Marek Jutel
Wroclaw Medical University
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Peer review status:ACCEPTED

08 Jul 2020Submitted to Allergy
08 Jul 2020Submission Checks Completed
08 Jul 2020Assigned to Editor
08 Jul 2020Reviewer(s) Assigned
20 Jul 2020Review(s) Completed, Editorial Evaluation Pending
30 Jul 20201st Revision Received
30 Jul 2020Submission Checks Completed
30 Jul 2020Assigned to Editor
30 Jul 2020Review(s) Completed, Editorial Evaluation Pending
30 Jul 2020Editorial Decision: Accept

Abstract

This systematic review evaluates the efficacyand 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); 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), theISS7 (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); 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).