Department of Dermatology and Venereology, First Hospital, Peking University, Beijing, China; Department of Dermatology and Allergy, Allergie-Centrum-Charité, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Research Division of Clinical Pharmacology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
J Allergy Clin Immunol. 2016 Jun;137(6):1742-1750.e4. doi: 10.1016/j.jaci.2015.12.1342. Epub 2016 Mar 31.
Chronic spontaneous urticaria (CSU) is defined by itchy hives, angioedema, or both for at least 6 weeks. Omalizumab, an anti-IgE antibody that affects mast cell and basophil function, is a promising new treatment option. As of now, however, the efficacy and safety of different doses of omalizumab used in clinical trials for CSU have not been systematically analyzed and summarized.
We sought to assess the efficacy and safety of different doses of omalizumab for the treatment of CSU in a meta-analysis of clinical trial results.
Suitable trials were identified by searching PubMed, Medline, Embase, and Web of Science databases and with the help of omalizumab's manufacturers. Only double-blind, randomized, placebo-controlled studies with omalizumab-treated versus placebo-treated patients with CSU were included in this analysis.
We identified 7 randomized, placebo-controlled studies with 1312 patients with CSU. Patients treated with omalizumab (75-600 mg every 4 weeks) had significantly reduced weekly itch and weekly wheal scores compared with the placebo group. Omalizumab's effects were dose dependent, with the strongest reduction in weekly itch and weekly wheal scores observed with 300 mg. Rates of complete response were significantly higher in the omalizumab group (relative risk, 4.55; P < .00001) and dose dependent, with the highest rates in the 300-mg group. Rates of patients with adverse events were similar in the omalizumab and placebo groups.
This meta-analysis provides high-quality evidence for the efficacy and safety of omalizumab in patients with CSU and for treating these patients with 300 mg of omalizumab every 4 weeks.
慢性自发性荨麻疹（CSU）的定义为至少 6 周出现瘙痒性风团、血管性水肿或两者兼有。奥马珠单抗是一种抗 IgE 抗体，可影响肥大细胞和嗜碱性粒细胞的功能，是一种有前途的新治疗选择。然而，到目前为止，用于 CSU 临床试验的不同剂量奥马珠单抗的疗效和安全性尚未得到系统分析和总结。
我们旨在通过对临床试验结果的荟萃分析，评估不同剂量奥马珠单抗治疗 CSU 的疗效和安全性。
通过检索 PubMed、Medline、Embase 和 Web of Science 数据库，并在奥马珠单抗制造商的帮助下，确定合适的试验。只有接受奥马珠单抗（75-600mg 每 4 周）治疗的 CSU 患者与安慰剂治疗的患者进行的双盲、随机、安慰剂对照研究才纳入本分析。
我们确定了 7 项随机、安慰剂对照研究，共纳入 1312 例 CSU 患者。与安慰剂组相比，接受奥马珠单抗治疗的患者每周瘙痒和每周风团评分显著降低。奥马珠单抗的疗效呈剂量依赖性，300mg 组的每周瘙痒和每周风团评分降低最为显著。奥马珠单抗组的完全缓解率显著高于安慰剂组（相对风险，4.55；P<.00001），且呈剂量依赖性，300mg 组的缓解率最高。奥马珠单抗组和安慰剂组的不良反应发生率相似。
本荟萃分析为奥马珠单抗治疗 CSU 患者的疗效和安全性提供了高质量证据，建议以每 4 周 300mg 的剂量治疗这些患者。
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