Zhao Zuotao, Zheng Yaqi, Song Xiaoting, Peng Chengyue, Liao Shuanglu, Zhang Peixin, Tan Yen, Huang Xiaojie, Zhang Litao
Department of Dermatology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China.
Tianjin Institute of Integrative Dermatology, Tianjin, China.
Clin Transl Allergy. 2025 May;15(5):e70052. doi: 10.1002/clt2.70052.
Most biological and synthetic target-specific drugs for antihistamine-refractory chronic spontaneous urticaria (CSU) have not been compared head-to-head. This systematic review and network meta-analysis evaluated their relative efficacy and safety.
Searches were conducted on PubMed, Embase, Web of Science and Cochrane library databases to March 25, 2024 for randomized trials. A random-effects model was used to calculate the network estimates reported as mean differences (MD) and odds ratios (OR) with corresponding 95% CIs. Main outcomes included the weekly urticaria activity score (UAS7), adverse events (AEs) and serious adverse events (SAEs).
23 randomized clinical trials with 6933 participants that compared 26 different interventions or dosages and placebos were included. Omalizumab 300 mg [MD -10.07, 95% CI (-11.35; -8.82)] continues to demonstrate superior efficacy compared with placebo. Remibrutinib, at doses of 35 mg once daily [MD -7.80, 95% CI (-12.76; -2.51)], 25 mg twice daily [MD -7.69, 95% CI (-9.85; -5.76)], and 10 mg twice daily [MD -7.61, 95% CI (-12.59; -2.47)], had the best overall performance for efficacy and safety. Dupilumab, fenebrutinib, and rilzabrutinib also showed greater efficacy than placebo. The results were similar for the proportion of patients who achieved UAS7 ≤ 6 or UAS7 = 0. No significant differences were found among all treatment comparisons for AEs and SAEs.
The findings of this study indicate that the biological agent omalizumab 300 mg and the oral small molecule remibrutinib at doses of 35 mg, 25 mg, or 10 mg are recommended for patients with antihistamine-refractory CSU.
PROSPERO: CRD42024516289.
大多数用于治疗抗组胺药难治性慢性自发性荨麻疹（CSU）的生物和合成靶向特异性药物尚未进行直接比较。本系统评价和网状Meta分析评估了它们的相对疗效和安全性。
检索了截至2024年3月25日的PubMed、Embase、Web of Science和Cochrane图书馆数据库中的随机试验。采用随机效应模型计算以均数差（MD）和比值比（OR）表示的网状估计值及相应的95%置信区间。主要结局包括每周荨麻疹活动评分（UAS7）、不良事件（AE）和严重不良事件（SAE）。
纳入了23项随机临床试验，共6933名参与者，比较了26种不同的干预措施、剂量或安慰剂。与安慰剂相比，300mg奥马珠单抗[MD -10.07，95%置信区间（-11.35；-8.82）]继续显示出卓越的疗效。瑞帕芦丁，每日一次35mg[MD -7.80，95%置信区间（-12.76；-2.51）]、每日两次25mg[MD -7.69，95%置信区间（-9.85；-5.76）]和每日两次10mg[MD -7.61，95%置信区间（-12.59；-2.47）]剂量组在疗效和安全性方面总体表现最佳。度普利尤单抗、非奈布替尼和利扎芦丁也显示出比安慰剂更显著的疗效。对于UAS7≤6或UAS7 = 0的患者比例，结果相似。在所有治疗组间的AE和SAE比较中未发现显著差异。
本研究结果表明，对于抗组胺药难治性CSU患者，推荐使用300mg生物制剂奥马珠单抗以及35mg、25mg或10mg剂量的口服小分子瑞帕芦丁。
PROSPERO：CRD42024516289。
