Huang Jing, Su Anping, Yang Jing, Zhuang Wei, Li Zhihui
Division of Thyroid Surgery, Department of General Surgery, West China Hospital, Sichuan University, Chengdu 610041, China.
Department of Pharmacy, Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen 361005, China.
J Clin Endocrinol Metab. 2024 Dec 18;110(1):159-165. doi: 10.1210/clinem/dgae417.
Teprotumumab, which targets the insulin-like growth factor-1 receptor, is the only drug approved by the US Food and Drug Administration (FDA) for the treatment of thyroid eye disease (TED).
This study aimed to identify potential safety signals of teprotumumab by analyzing postmarketing safety data from the FDA Adverse Event Reporting System (FAERS) database in 2023.
The case/noncase approach was used to estimate the reporting odds ratio (ROR) and information component (IC) with relevant 95% CI for adverse events (AEs) that numbered 3 or more.
A total of 2158 cases were included in the analysis. Main safety signals identified were ear and labyrinth disorders, reproductive system and breast disorders, metabolism and nutrition disorders, and gastrointestinal disorders. Specifically, autophony (ROR [95% CI] = 4188.34 [1403.29-12500.8]), eyelid retraction (ROR [95% CI] = 2094.17 [850.69-5155.29]), permanent deafness (ROR [95% CI] = 1552.35 [789.07-3053.98]), bilateral deafness (ROR [95% CI] = 73.12 [41.14-129.97]), inflammatory bowel disease (ROR [95% CI] = 23.26 [13.46-40.19]), hyperglycemic hyperosmolar nonketotic syndrome (ROR [95% CI] = 17.75 [5.70-55.28]), and amenorrhea (ROR [95% CI] = 47.98 [36.22-63.54]) showed significant safety signals with teprotumumab.
This study identified ear and labyrinth disorders, and reproductive system and breast disorders, as specific safety signals of teprotumumab. Clinicians and pharmacists should be vigilant regarding these AEs. However, available data are currently insufficient, and further pharmacovigilance and surveillance are needed to fully understand this issue.
靶向胰岛素样生长因子-1受体的替普罗珠单抗是美国食品药品监督管理局（FDA）批准的唯一用于治疗甲状腺眼病（TED）的药物。
本研究旨在通过分析2023年FDA不良事件报告系统（FAERS）数据库的上市后安全数据，识别替普罗珠单抗潜在的安全信号。
采用病例/非病例方法，对数量为3例或更多的不良事件（AE）估计报告比值比（ROR）和信息成分（IC）以及相关的95%置信区间（CI）。
分析共纳入2158例病例。识别出的主要安全信号包括耳和迷路疾病、生殖系统和乳腺疾病、代谢和营养疾病以及胃肠道疾病。具体而言，自听过强（ROR [95% CI] = 4188.34 [1403.29 - 12500.8]）、眼睑退缩（ROR [95% CI] = 2094.17 [850.69 - 5155.29]）、永久性耳聋（ROR [95% CI] = 1552.35 [789.07 - 3053.98]）、双侧耳聋（ROR [95% CI] = 73.12 [41.14 - 129.97]）、炎症性肠病（ROR [95% CI] = 23.26 [13.46 - 40.19]）、高血糖高渗非酮症综合征（ROR [95% CI] = 17.75 [5.70 - 55.28]）以及闭经（ROR [95% CI] = 47.98 [36.22 - 63.54]）显示出与替普罗珠单抗相关的显著安全信号。
本研究识别出耳和迷路疾病以及生殖系统和乳腺疾病是替普罗珠单抗的特定安全信号。临床医生和药剂师应对这些不良事件保持警惕。然而，目前可用数据不足，需要进一步的药物警戒和监测以充分了解这一问题。
