loading page

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 Maurer,
  • Graham Ogg,
  • Peck Ong,
  • Liam O'Mahony,
  • Jürgen Schwarze,
  • Thomas Werfel,
  • Carlos Canelo-Aybar,
  • Oscar Palomares,
  • Marek Jutel
Ioana Agache
Transylvania University of Brasov

Corresponding Author:ibrumaru@unitbv.ro

Author Profile
Claudio Rocha
Biomedical Research Institute Sant Pau
Author Profile
Yang Song
Biomedical Research Institute Sant Pau
Author Profile
Pablo Alonso-Coello
Hospital Sant Pau
Author Profile
Ivan Sola
Biomedical Research Institute
Author Profile
Jessica Beltran
Biomedical Research Institute Sant Pau
Author Profile
Margarita Posso
Author Profile
Cezmi Akdis
University of Zurich
Author Profile
Mubeccel Akdis
University of Zürich
Author Profile
Knut Brockow
Technical University of Munich
Author Profile
T. Chivato
Univ CEU San Pablo
Author Profile
Stefano R. Del Giacco
University of Cagliari Faculty of Medicine
Author Profile
Thomas Eiwegger
The Hospital for Sick Children
Author Profile
Kilian Eyerich
Author Profile
Ana Giménez Arnau
Hospital del Mar. Institut Mar d´Investigacions Mediques
Author Profile
Jan Gutermuth
Universitair Ziekenhuis Brussel
Author Profile
Emma Guttmann-Yassky
Rockefeller University
Author Profile
Marcus Maurer
Charité Universitätsmedizin Berlin
Author Profile
Graham Ogg
University of Oxford
Author Profile
Peck Ong
Childrens Hospital Los Angeles, University of Southern California Keck School of Medicine
Author Profile
Liam O'Mahony
University College Cork National University of Ireland
Author Profile
Jürgen Schwarze
University of Edinburgh, Edinburgh
Author Profile
Thomas Werfel
Hannover Medical School
Author Profile
Carlos Canelo-Aybar
Biomedical Research Institute Sant Pau
Author Profile
Oscar Palomares
Complutense University of Madrid
Author Profile
Marek Jutel
Wroclaw Medical University
Author Profile


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).
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
Jan 2021Published in Allergy volume 76 issue 1 on pages 59-70. 10.1111/all.14547