Manzoor Humayun, Razi Foha, Rasheed Amina, Sarfraz Zouina, Sarfraz Azza, Robles-Velasco Karla, Felix Miguel, Cherrez-Ojeda Ivan
Department of Research, Bahria University Medical & Dental College, Karachi 75260, Pakistan.
Department of Research, Nishtar Medical University, Multan 60000, Pakistan.
Healthcare (Basel). 2022 Dec 19;10(12):2579. doi: 10.3390/healthcare10122579.
Chronic urticaria is a debilitating skin condition that is defined as itchy hives at least twice a week and lasting for six or more weeks, with or without angioedema. Chronic spontaneous urticaria (CSU) is a form of disease that is witnessed in two-thirds of those with chronic urticaria. This meta-analysis explores the efficacy of differential dosages of omalizumab for outcomes of weekly itching scores, weekly wheal scores, urticarial assessment score 7 (UAS7), and responder rates. Adhering to PRISMA Statement 2020 guidelines, a systematic search of PubMed/MEDLINE, Scopus, Embase, and Web of Science was conducted until 15 September 2022. A combination of the following keywords was used: omalizumab and chronic urticaria. Data comprising clinical trial ID, name, author/year, country, dosage and time of intervention, inclusion criteria, mean age, female gender, and racial grouping information were obtained. The meta-analytical outcomes were analyzed in RevMan 5.4. The risk-of-bias assessment was conducted using version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2). A total of 10 trials comprising 1705 patients with CSU were included. Notably, 1162 belonged to the intervention group, while 543 were controls. A total of 70.4% of the participants were female in the intervention group, while 65.6% of them were female in the control group. The overall mean age was 38.64 ± 10.66 years. Weekly itch score outcomes were most notable with 150 mg dosage (Cohen’s d = −2.6, 95% CI = −4.75, −0.46, p = 0.02). The weekly wheal score outcomes had the largest effect size with 300 mg dosage (Cohen’s d = −1.45, 95% CI = −2.2, −0.69, p = 0.0002). For UAS7 outcomes, the largest effect size was yielded with 150 mg dosage (Cohen’s d = −6.92, 95% CI: −10.38, −3.47, p < 0.0001). The response rate to omalizumab had a likelihood of being higher with 300 mg of intervention compared to placebo (OR = 8.65, 95% CI = 4.42, 16.93, p < 0.0001). Well-rounded urticarial symptom resolution was observed with 150 mg and 300 mg dosages of omalizumab. Improvement of UAS7 was more comparable with 150 mg dosage, whereas the chance of response to treatment was higher with 300 mg dosage. Our findings support omalizumab as an effective intervention for adult and pediatric populations that are resistant to many therapies, including high-dose H1-antihistamines.
慢性荨麻疹是一种使人衰弱的皮肤疾病，定义为每周至少出现两次瘙痒性风团，持续六周或更长时间，伴或不伴有血管性水肿。慢性自发性荨麻疹（CSU）是慢性荨麻疹患者中三分之二所患的一种疾病形式。本荟萃分析探讨了不同剂量奥马珠单抗对每周瘙痒评分、每周风团评分、荨麻疹评估评分7（UAS7）及缓解率等指标的疗效。遵循《2020年PRISMA声明》指南，截至2022年9月15日，对PubMed/MEDLINE、Scopus、Embase和Web of Science进行了系统检索。使用了以下关键词组合：奥马珠单抗和慢性荨麻疹。获取了包括临床试验ID、名称、作者/年份、国家、干预剂量和时间、纳入标准、平均年龄、女性性别及种族分组信息的数据。在RevMan 5.4中对荟萃分析结果进行了分析。使用Cochrane随机试验偏倚风险工具第2版（RoB 2）进行偏倚风险评估。共纳入10项试验，涉及1705例CSU患者。值得注意的是，1162例属于干预组，543例为对照组。干预组中70.4%的参与者为女性，对照组中65.6%为女性。总体平均年龄为38.64±10.66岁。150mg剂量时每周瘙痒评分结果最为显著（科恩d值=-2.6，95%置信区间=-4.75，-0.46，p=0.02）。300mg剂量时每周风团评分结果的效应量最大（科恩d值=-1.45，95%置信区间=-2.2，-0.69，p=0.0002）。对于UAS7结果，150mg剂量产生的效应量最大（科恩d值=-6.92，95%置信区间：-10.38，-3.47，p<0.0001）。与安慰剂相比，300mg干预剂量的奥马珠单抗缓解率更高（比值比=8.65，95%置信区间=4.42，16.93，p<0.0001）。150mg和300mg剂量的奥马珠单抗均观察到全面的荨麻疹症状缓解。150mg剂量时UAS7的改善更具可比性，而300mg剂量时治疗反应的可能性更高。我们的研究结果支持奥马珠单抗作为对包括高剂量H1抗组胺药在内的多种疗法耐药的成人和儿童群体的有效干预措施。
