@article{272446caa0824002b0cfd4bf3abfe8ec,
title = "Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines",
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 = "Adolescent, Adult, Aged, Anti-Allergic Agents/adverse effects, Biological Products/therapeutic use, Child, Chronic Urticaria, Humans, Middle Aged, Omalizumab/adverse effects, Quality of Life, Urticaria/drug therapy, Young Adult",
author = "Ioana Agache and Claudio Rocha and Ana Pereira and Yang Song and Pablo Alonso-Coello and Ivan Sol{\`a} and Jessica Beltran and Margarita Posso and Akdis, {Cezmi A} and Mubeccel Akdis and Knut Brockow and Tomas Chivato and {Del Giacco}, Stefano and Thomas Eiwegger and Kilian Eyerich and Ana Gim{\'e}nez-Arnau and Jan Gutermuth and Emma Guttman-Yassky and Marcus Maurer and Graham Ogg and Peck Ong and Liam O'Mahony and J{\"u}rgen Schwarze and Thomas Werfel and Carlos Canelo-Aybar and Oscar Palomares and Marek Jutel",
note = "Funding Information: IA serves as associate editor of Allergy. YS, MP, PA‐C, CR, IS, JB, and CCA declare funding from EAACI. CA reports grants from Allergopharma, Idorsia, Swiss National Science Foundation, Christine K{\"u}hne‐Center for Allergy Research and Education, European Commission Horizon 2020 Framework Programme, Cure, Novartis Research Institutes, Astra Zeneca, Scibase, and is on the Sanofi/Regeneron advisory board. MA declares grants from Allergopharma, Idorsia, Swiss National Science Foundation, Christine K{\"u}hne‐Center for Allergy Research and Education, European Commission's Horizon's 2020 Framework Programme, Cure, Novartis Research Institutes, AstraZeneca, Scibase, and other from Sanofi/Regeneron. KB has received personal fees from Novartis. SG reports personal fees from AstraZeneca, GSK and Novartis. TE has received grants or other from DBV, Innovation Fund Denmark, Regeneron, the Allergy and Anaphylaxis Program SickKids; serves as associate editor for Allergy and in the local advisory board of ALK. KE reports grants and/or personal fees from AbbVie, BMS, Boehringer Ingelheim, Lilly, LEO, Janssen, grants from Galapagos, UCB, Novartis, and Sanofi. AG‐A declares grants and/or personal fees from Novartis, Uriach Pharma, GSK, Regeneron Sanofi, Instituto Carlos III FEDER, Leo Pharma, Almirall, Amgen, Menarini, MSD. JG declares grants and/or personal fees from Sanofi‐Regeneron, Novartis, AbbVie, Janssen, LEO Pharma, L{\textquoteright}{\`O}real, Mylan, and has been issued a patent. MM reports grants and/or personal fees from Sanofi/Regeneron, Allakos, Alnylam, Amgen, Aralez, ArgenX, AstraZeneca, BioCryst, Blueprint, Celldex, Centogene, CSL Behring, Dyax, FAES, Genentech, GINNOVATION, Innate Pharma, Kalvista, Kyowa Kirin, Leo Pharma, Lilly, Menarini, Moxie, Novartis, Pharming, Pharvaris, Roche, Shire/Takeda, Third HarmonicBio, UCB, and Uriach. GO reports personal fees, grants and/or nonfinancial support from the University of Oxford, Sanofi, Celgene, Novartis, Janssen, Orbit, UCB, AnaptysBio, Eli Lilly, and Orbit Discovery. O. Peck reports grants and others from Regeneron, Pfizer, AbbVie, and Incyte. LOM has received grants from GSK and personal fees from AHL. O. Palomares received research grants from Inmunotek SL and Novartis; received fees for giving scientific lectures from: Allergy Therapeutics, Amgen, AstraZeneca, Diater, GSK, Inmunotek S.L, Novartis, Sanofi‐Genzyme and Stallergenes; participated in advisory boards from Novartis and Sanofi‐Genzyme. MJ reports personal fees from ALK‐Abello, Allergopharma, Stallergenes, Anergis, Allergy Therapeutics, Circassia, Leti, Biomay, HAL, AstraZeneca, GSK, Novartis, Teva, Vectura, UCB, Takeda, Roche, Janssen, MedImmune, and Chiesi. All other authors have no conflict of interest within the scope of the submitted work. Publisher Copyright: {\textcopyright} 2020 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.",
year = "2021",
month = jan,
doi = "10.1111/all.14547",
language = "English",
volume = "76",
pages = "59--70",
journal = "Allergy: European Journal of Allergy and Clinical Immunology",
issn = "0105-4538",
publisher = "Wiley-Blackwell Publishing Ltd",
number = "1",
}