BackgroundLimited information is available on the use of omalizumab (OMA) updosing since its introduction as a second‐line therapy in chronic spontaneous urticaria (CSU) in 2014. Practical guidelines from health authorities are lacking, and the specific characteristics of patients requiring higher doses remain unknown. Our objectives were to characterize the patterns of OMA updosing (defined as changes in dose and/or injection intervals), to identify the predictive factors associated with updosing, and to improve CSU management.MethodsWe conducted a prospective, multicentric, real‐life observational study, including patients diagnosed with CSU and starting OMA. The data were collected at 0, 3, 6, and 9 months. The primary endpoint was the frequency of OMA updosing at 3 months. The secondary endpoints included an analysis of updosed patients' profile, and an assessment of OMA efficacy and safety.ResultsWe included 153 patients. Twenty percent of patients were updosed at 3 months, and 27% in total during the 9‐month follow‐up. Practitioners mainly chose to increase the frequency of injections (66%). At baseline, the updosed patients were more likely to have more severe CSU (UCT < 4, p < 0.030), a lower lymphocyte count (<2000/mm3, p = 0.037), and low IgE levels (<70 UI/mL, p = 0.024). The side effects of OMA were not more frequent after updosing.ConclusionOne in five patient underwent updosing within just 3 months. OMA updosing is frequent in particular in cases of severe disease and low IgE blood levels.

中文翻译：

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慢性自发性荨麻疹奥马珠单抗剂量模式和预测因素的特征：一项前瞻性多中心观察研究


背景自 2014 年将奥马珠单抗 (OMA) 作为二线疗法引入慢性自发性荨麻疹 (CSU) 以来，有关使用奥马珠单抗 (OMA) 剂量的信息有限。卫生当局缺乏实用指南，并且需要更高剂量的患者的具体特征仍然存在未知。我们的目标是描述 OMA 剂量增加的模式（定义为剂量和/或注射间隔的变化），确定与剂量增加相关的预测因素，并改善 CSU 管理。方法我们进行了一项前瞻性、多中心、现实观察研究，包括诊断为 CSU 并开始 OMA 的患者。数据在 0、3、6 和 9 个月时收集。主要终点是 3 个月时 OMA 剂量增加的频率。次要终点包括对剂量增加患者概况的分析以及 OMA 疗效和安全性的评估。结果我们纳入了 153 名患者。 20% 的患者在 3 个月时增加了剂量，在 9 个月的随访期间总共有 27% 的患者增加了剂量。从业者主要选择增加注射频率（66%）。在基线时，增加剂量的患者更有可能出现更严重的 CSU（UCT < 4，p < 0.030）、较低的淋巴细胞计数（<2000/mm3，p = 0.037）和较低的 IgE 水平（<70 UI/毫升，p = 0.024）。增加剂量后，OMA 的副作用并没有更加频繁。结论 五分之一的患者在短短 3 个月内接受了增加剂量。 OMA 剂量增加很频繁，特别是在患有严重疾病和低 IgE 血液水平的情况下。