与变应原特异性免疫疗法、奥马珠单抗和度普利尤单抗相关的过敏反应：一项基于美国食品药品监督管理局不良事件报告系统的真实世界研究。
Anaphylaxis Associated With Allergen Specific Immunotherapy, Omalizumab, and Dupilumab: A Real World Study Based on the US Food and Drug Administration Adverse Event Reporting System.
作者信息
Bian Sainan, Zhang Pingping, Li Lisha, Wang Zixi, Cui Le, Xu Yingyang, Guan Kai, Zhao Bin, Chen Zhuanggui
机构信息
Department of Allergy, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.
Beijing Key Laboratory of Precision Medicine for Diagnosis and Treatment of Allergic Disease, Peking Union Medical College, Beijing, China.
出版信息
Front Pharmacol. 2021 Oct 22;12:767999. doi: 10.3389/fphar.2021.767999. eCollection 2021.
Real-world studies on the allergen specific immunotherapy (AIT), omalizumab, and dupilumab associated anaphylactic events are limited. We aimed to analyze the characteristics of drug associated anaphylaxis, and to compare the differences among different drugs. A disproportionality analysis and Bayesian analysis were used in data mining to identify suspected anaphylaxis associated with AIT, omalizumab, and dupilumab based on the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from January 2004 to March 2021. Demographic information, time interval to onset, and death rates of AIT, omalizumab, and dupilumab associated anaphylaxis were also analyzed. Totally 9,969 anaphylactic events were identified. Reports of AIT, omalizumab, and dupilumab associated anaphylactic events were 64, 7,784, and 2,121, respectively. AIT had a high reporting odds ratio (ROR) of 5.03 [95%confidental interval (CI) 3.69-6.85], followed by omalizumab (ROR 2.24, 95% CI 2.18-2.29), and dupilumab had a negative signal for anaphylaxis. In children, most anaphylactic reactions (68%) were reported in the 12-17-year-old group. More reports of anaphylaxis related to AIT were in boys (73%), while more reports of anaphylaxis related to omalizumab (63%) and dupilumab (58%) were in girls. Most symptoms occurred on the day of drug initiation. The death rate of AIT related anaphylaxis was the lowest (0%), the death rate of omalizumab was 0.87%, while the death rate of dupilumab was 4.76%. No significant differences were observed among these drugs. AIT and omalizumab had a positive signal for anaphylaxis, while dupilumab had a negative signal for anaphylaxis. Patients should be strictly monitored after administration of AIT and also biologics. It also gives us a suggestion for choosing a combined biologics with AIT when the risk of anaphylaxis was considered.
关于过敏原特异性免疫疗法（AIT）、奥马珠单抗和度普利尤单抗相关过敏反应事件的真实世界研究有限。我们旨在分析药物相关过敏反应的特征，并比较不同药物之间的差异。在数据挖掘中，我们使用了不成比例分析和贝叶斯分析，基于美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）中2004年1月至2021年3月的数据，识别与AIT、奥马珠单抗和度普利尤单抗相关的疑似过敏反应。我们还分析了AIT、奥马珠单抗和度普利尤单抗相关过敏反应的人口统计学信息、发病时间间隔和死亡率。共识别出9969起过敏反应事件。与AIT、奥马珠单抗和度普利尤单抗相关过敏反应事件的报告分别为64例、7784例和2121例。AIT的报告比值比（ROR）较高，为5.03[95%置信区间（CI）3.69 - 6.85]，其次是奥马珠单抗（ROR 2.24，95% CI 2.18 - 2.29），度普利尤单抗在过敏反应方面呈阴性信号。在儿童中，大多数过敏反应（68%）报告发生在12 - 17岁组。与AIT相关的过敏反应报告中男孩较多（73%），而与奥马珠单抗（63%）和度普利尤单抗（58%）相关的过敏反应报告中女孩较多。大多数症状在开始用药当天出现。AIT相关过敏反应的死亡率最低（0%），奥马珠单抗的死亡率为0.87%，而度普利尤单抗的死亡率为4.76%。这些药物之间未观察到显著差异。AIT和奥马珠单抗在过敏反应方面呈阳性信号，而度普利尤单抗在过敏反应方面呈阴性信号。在使用AIT以及生物制剂后，应对患者进行严格监测。在考虑过敏反应风险时，这也为选择与AIT联合使用的生物制剂提供了建议。
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