This is a retrospective review of the Winnipeg Regional Health Authority’s (WRHA) angioedema patients who were dispensed icatibant in hospital. Icatibant is a bradykinin B2 receptor antagonist indicated for Hereditary Angioedema (HAE) types I and II and is used off-label for HAE with normal C1INH (HAE-nC1INH) and ACE-inhibitor induced angioedema (ACEIIAE). The WRHA’s use of icatibant is regulated by the Allergist on call. We characterized icatibant's use and the timeline from patient presentation, compared the real-world experience with the FAST-3 trial and hypothesized the factors which may affect response to icatibant. Background data were collected on patients. Angioedema attack-related data included administered medications, performed investigations and the timeline to endpoints such as onset of symptom relief. Data was analyzed in R with the package “survival.” Time-to-event data was analyzed using the Peto–Peto Prentice method or Mann–Whitney U-test. Data was also compared with published clinical trial data using the Sign Test. Fisher’s Exact Test was used to produce descriptive statistics. Overall, 21 patients accounted for 23 angioedema attacks treated with icatibant. Approximately half the patients had a diagnosis of HAE-nC1IHN and half of ACEIIAE. Of those presenting with angioedema, 65% were first treated with conventional medication. Patients without a prior angioedema diagnosis were evaluated only 40–50% of the time for C4 levels or C1INH function or level. The median time from patients’ arrival to the emergency department until the Allergy consultant’s response was 1.77 h. Patients with HAE-nC1IHN had median times to onset of symptom relief and final clinical outcome (1.13 h, p = 0.34; 3.50 h, p = 0.11) similar to those reported in FAST-3 for HAE I/II. Patients with ACEIIAE had longer median times to onset of symptom relief (4.86 h, p = 0.01) than predicted. HAE-nC1INH may be an appropriate indication for treatment with icatibant. Conversely, the results of this study do not support the use of icatibant for the treatment of ACEIIAE, concordant with a growing body of literature. Patients should be stratified into groups of more- or less-likely icatibant-responders through history and laboratory investigations in order to prevent potential delays.

中文翻译：

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温尼伯地区卫生局对艾替替班使用情况的审查


这是对温尼伯地区卫生局 (WRHA) 在医院配发艾替替班的血管性水肿患者的回顾性评价。 Icatibant 是一种缓激肽 B2 受体拮抗剂，适用于 I 型和 II 型遗传性血管性水肿 (HAE)，并且用于超说明书治疗 C1INH 正常 (HAE-nC1INH) 和 ACE 抑制剂诱发的血管性水肿 (ACEIIAE) 的 HAE。 WRHA 对艾替班特的使用受到值班过敏症专家的监管。我们描述了艾替班特的使用和患者就诊的时间线，将现实世界的经验与 FAST-3 试验进行了比较，并假设了可能影响艾替班特反应的因素。收集患者的背景数据。血管性水肿发作相关数据包括服用的药物、进行的调查以及症状缓解等终点的时间表。使用 R 包“survival”对数据进行分析。使用 Peto-Peto Prentice 方法或 Mann-Whitney U 检验分析事件发生时间数据。还使用符号测试将数据与已发表的临床试验数据进行了比较。费希尔精确检验用于生成描述性统计数据。总体而言，21 名患者发生了 23 次接受艾替替班治疗的血管性水肿发作。大约一半的患者诊断为 HAE-nC1IHN，一半的患者诊断为 ACEIIAE。在出现血管性水肿的患者中，65% 首先接受常规药物治疗。先前没有血管性水肿诊断的患者仅在 40-50% 的情况下评估 C4 水平或 C1INH 功能或水平。从患者到达急诊室到过敏顾问做出反应的中位时间为 1.77 小时。 HAE-nC1IHN 患者的症状缓解和最终临床结果的中位时间（1.13 小时，p = 0.34；3.50 小时，p = 0.11）与 FAST-3 中报告的 HAE I/II 相似。 ACEIIAE 患者出现症状缓解的中位时间（4.86 小时，p = 0.01）比预期更长。 HAE-nC1INH 可能是艾替班特治疗的合适指征。相反，本研究的结果不支持使用艾替班特治疗 ACEIIAE，这与越来越多的文献一致。应通过病史和实验室检查将患者分为或多或少可能出现艾替替班反应的组，以防止潜在的延误。