Introduction

Due to daily hives with itch, sleeplessness, and unforeseen development of angioedema, chronic spontaneous urticaria significantly impairs quality of life, often for years. Its management is challenging. In most cases, H1-antihistamines are not effective. Although the disease is not characterized by specific IgE antibodies against allergens, the last decade demonstrated that neutralizing IgE by using the monoclonal anti-IgE antibody Omalizumab is safe and effective. Nevertheless, symptoms are not controlled by Omalizumab in approximately one-fourth of patients.

Areas covered

This review is focused on Ligelizumab (QGE031), a next-generation non-triggering fully human monoclonal antibody, with higher affinity to IgE compared to Omalizumab.

Expert opinion

In chronic spontaneous urticaria, subcutaneous Ligelizumab once per month for five months has shown a clear dose–response relationship with respect to symptoms. Superiority over Omalizumab was noted whereas the safety profile was similar. Most common side effects were injection site reactions. In the near future, results from phase 3 trials, two of them including more than 1000 patients each, are awaited. Having a higher affinity to IgE and being more effective than Omalizumab, Ligelizumab has the potential to free chronic urticaria patients from year-long daily annoying symptoms that did not respond to standard therapy as recommended by current guidelines.

中文翻译：

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利格珠单抗用于治疗慢性自发性荨麻疹。

介绍

由于日常荨麻疹伴瘙痒，失眠和无法预料的血管性水肿发展，慢性自发性荨麻疹通常会持续数年，严重损害生活质量。其管理具有挑战性。在大多数情况下，H1-抗组胺药无效。尽管该疾病的特征不是针对过敏原的特异性IgE抗体，但最近十年证明，使用单克隆抗IgE抗体Omalizumab中和IgE是安全有效的。然而，大约四分之一的患者的症状不受奥马珠单抗的控制。

覆盖区域

这项综述的重点是与奥马珠单抗相比，对IgE具有更高亲和力的下一代非触发性全人类单克隆抗体Ligelizumab（QGE031）。

专家意见

在慢性自发性荨麻疹中，皮下注射利杰珠单抗每月一次，持续五个月，已显示出与症状明确的剂量反应关系。注意到比奥马利珠单抗优越，而安全性相似。最常见的副作用是注射部位反应。在不久的将来，我们正在等待3期试验的结果，其中两个试验各有1000多名患者。Ligelizumab对IgE具有更高的亲和力，并且比Omalizumab更有效，因此有可能使慢性荨麻疹患者摆脱一年来的每日烦人症状，这些症状对当前指南所建议的标准疗法无反应。