TY - JOUR
T1 - Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria
T2 - A systematic review for the EAACI Biologicals Guidelines
AU - Agache, Ioana
AU - Rocha, Claudio
AU - Pereira, Ana
AU - Song, Yang
AU - Alonso-Coello, Pablo
AU - Solà, Ivan
AU - Beltran, Jessica
AU - Posso, Margarita
AU - Akdis, Cezmi A.
AU - Akdis, Mubeccel
AU - Brockow, Knut
AU - Chivato, Tomas
AU - del Giacco, Stefano
AU - Eiwegger, Thomas
AU - Eyerich, Kilian
AU - Giménez-Arnau, Ana
AU - Gutermuth, Jan
AU - Guttman-Yassky, Emma
AU - Maurer, Marcus
AU - Ogg, Graham
AU - Ong, Peck
AU - O’Mahony, Liam
AU - Schwarze, Jürgen
AU - Werfel, Thomas
AU - Canelo-Aybar, Carlos
AU - Palomares, Oscar
AU - Jutel, Marek
N1 - Publisher Copyright:
© 2020 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.
PY - 2021/1
Y1 - 2021/1
N2 - 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).
AB - 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).
KW - chronic idiopathic urticaria
KW - chronic spontaneous urticaria
KW - itch severity score
KW - omalizumab
KW - urticaria activity score
UR - https://www.scopus.com/pages/publications/85090300070
U2 - 10.1111/all.14547
DO - 10.1111/all.14547
M3 - Article
C2 - 32767573
AN - SCOPUS:85090300070
SN - 0105-4538
VL - 76
SP - 59
EP - 70
JO - Allergy: European Journal of Allergy and Clinical Immunology
JF - Allergy: European Journal of Allergy and Clinical Immunology
IS - 1
ER -