State Dermatology Department, Hippokratio General Hospital of Thessaloniki, Greece.
First Dermatology Department, Aristotle University of Thessaloniki, Greece.
Eur J Dermatol. 2020 Dec 1;30(6):716-722. doi: 10.1684/ejd.2020.3919.
Omalizumab is approved for the treatment of chronic spontaneous urticaria (CSU) not responding to antihistamines. Data on omalizumab use in real-world settings and in different populations are lacking.
To record our five-year experience of omalizumab use in patients with refractory CSU in a real-world setting.
MATERIALS & METHODS: A retrospective analysis of medical records of 80 patients with refractory CSU was performed. Demographic, and clinical characteristics, patterns of response, discontinuation strategies and rate of recurrence were analysed.
Eighty individuals were included. UAS7 and DLQI significantly decreased from baseline. Complete response was achieved in 86.3%. Late response was observed at 27.5% of the patients. After discontinuation, 21.7% of patients reinitiated omalizumab due to relapse. The mean number of omalizumab administrations up to first discontinuation was 6.8 (based on an approach to shorten the treatment interval). Only 15.0% of patients experienced adverse events during treatment.
Omalizumab, with long-term management, was highly effective and safe in achieving control of refractory CSU, with more favourable responses compared to Phase III clinical trials.
奥马珠单抗获批用于治疗抗组胺药物治疗无效的慢性自发性荨麻疹（CSU）。目前缺乏奥马珠单抗在真实世界环境和不同人群中的使用数据。
记录我们在真实环境中使用奥马珠单抗治疗难治性 CSU 患者的五年经验。
对 80 例难治性 CSU 患者的病历进行回顾性分析。分析了人口统计学和临床特征、反应模式、停药策略和复发率。
共纳入 80 人。UAS7 和 DLQI 自基线显著降低。86.3%的患者达到完全缓解。27.5%的患者出现迟发反应。停药后，21.7%的患者因复发重新开始奥马珠单抗治疗。首次停药前奥马珠单抗的平均给药次数为 6.8 次（基于缩短治疗间隔的方法）。治疗期间仅有 15.0%的患者出现不良反应。
奥马珠单抗长期管理在控制难治性 CSU 方面非常有效且安全，与 III 期临床试验相比，具有更有利的反应。
