Effectiveness of omalizumab in adolescent and adult patients with chronic idiopathic/spontaneous urticaria: a systematic review of ‘real-world’ evidence

<b>Introduction</b>: Chronic idiopathic/spontaneous urticaria (CIU/CSU) is a dermatological condition characterized by itchy wheals and/or angioedema of continuous or intermittent duration of ≥6 weeks with a high burden of disease and impact on quality of life. Omalizumab is a recombinant humanized monoclonal antibody that inhibits the binding of IgE to high affinity receptors, and is approved for the CIU/CSU indication. The objective of this systematic review was to evaluate and synthesize the evidence on the real-world effectiveness of omalizumab in CIU/CSU in daily clinical practice. <b>Areas covered</b>: This review of 84 observational effectiveness studies covers treatments (dosing, medication use), clinical outcomes (treatment response, disease activity, quality of life), and safety. <b>Expert opinion</b>: The clinical outcomes observed across studies underscore the real-world effectiveness of omalizumab in the management of CIU/CSU. Continued treatment may assist patients showing an initial response to achieve a complete treatment response. Response rates are aligned with observed changes in disease activity, symptom experience, and quality of life, and this across subtypes of CIU/CSU. The positive therapeutic profile is complemented by a positive safety profile. The real-world evidence summarized here points convincingly at the high degree of effectiveness of omalizumab in the treatment of CIU/CSU in daily clinical practice.

**引言**：慢性特发性/自发性荨麻疹（Chronic idiopathic/spontaneous urticaria, CIU/CSU）是一种皮肤科病症，以持续或间歇发作≥6周的瘙痒性风团和/或血管性水肿为特征，疾病负担沉重且对患者生活质量造成显著负面影响。奥马珠单抗（omalizumab）是一种重组人源化单克隆抗体（recombinant humanized monoclonal antibody），可抑制免疫球蛋白E（Immunoglobulin E, IgE）与高亲和力受体（high affinity receptors）的结合，已获批用于CIU/CSU的适应症治疗。本系统评价旨在评估并综合日常临床实践中奥马珠单抗治疗CIU/CSU的真实世界有效性证据。
**涵盖范围**：本综述纳入84项观察性有效性研究，内容涵盖治疗相关信息（给药方案、药物使用情况）、临床结局（治疗应答、疾病活动度、生活质量）以及安全性。
**专家观点**：各项研究中观察到的临床结局证实了奥马珠单抗在CIU/CSU管理中的真实世界有效性。对于初始治疗产生应答的患者，持续用药可帮助其实现完全治疗应答。应答率与疾病活动度、症状体验及生活质量的改善相契合，且这一效果在CIU/CSU的所有亚型中均有体现。优良的治疗获益特征辅以良好的安全性特征。本文总结的真实世界证据有力地表明，奥马珠单抗在日常临床实践中治疗CIU/CSU的有效性极高。