Agache Ioana, Rocha Claudio, Pereira Ana, Song Yang, Alonso-Coello Pablo, Solà Ivan, Beltran Jessica, Posso Margarita, Akdis Cezmi A, Akdis Mubeccel, Brockow Knut, Chivato Tomas, Del Giacco Stefano, Eiwegger Thomas, Eyerich Kilian, Giménez-Arnau Ana, Gutermuth Jan, Guttman-Yassky Emma, Maurer Marcus, Ogg Graham, Ong Peck, O'Mahony Liam, Schwarze Jürgen, Werfel Thomas, Canelo-Aybar Carlos, Palomares Oscar, Jutel Marek
Faculty of Medicine, Transylvania University, Brasov, Romania.
Iberoamerican Cochrane Centre - Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain.
Allergy. 2021 Jan;76(1):59-70. doi: 10.1111/all.14547. Epub 2020 Sep 7.
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).
本系统评价评估了奥马珠单抗治疗慢性自发性荨麻疹（CSU）的疗效和安全性。检索了PubMed、Embase和Cochrane图书馆中的随机对照试验（RCT）。考虑了与CSU相关的关键和重要结局。使用GRADE评估偏倚风险和证据的确定性。评估了10项RCT，包括1620名年龄在12至75岁的受试者，他们接受奥马珠单抗治疗16至40周。150mg奥马珠单抗不会使荨麻疹活动评分（UAS）7产生临床意义上的改善（高确定性）（平均差（MD）-5；95%置信区间（CI）-7.75至-2.25），瘙痒严重程度评分（ISS）7（MD -2.15；95%CI -3.2至-1.1）也不会增加（中度确定性）生活质量（QoL）（皮肤病生活质量指数（DLQI）；MD -2.01；95%CI -3.22至-0.81），但会减少（中度确定性）急救药物的使用（MD -1.68；95%CI -2.95至-0.4）。300mg奥马珠单抗会使UAS7产生临床意义上的改善（中度确定性）（MD -11.05；95%CI -12.87至-9.24）、ISS7（MD -4.45；95%CI -5.39至-3.51）和QoL（高确定性）（DLQI；MD -4.03；95%CI -5.56至-2.5），并减少（中度确定性）急救药物的使用（MD -2.04；95%CI -3.19至-0.88）以及与药物相关的严重不良事件（风险比（RR）0.77；95%CI 0.20至2.91）。
