Abstract：
OBJECTIVE: Teprotumumab plays an important role in thyroid eye disease pathogenesis and progression. We intend to mine the adverse event (AE) signals from a relevant database, thereby contributing to the safe use of teprotumumab.
METHODS: The data obtained from the ASCII data packages in the FAERS database from January 2020 to the second quarter of 2023 were imported into the SAS software (version 9.4) for data cleaning and analysis. Disproportionality analysis was performed using the reporting odds ratio (ROR) in conjunction with the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) omnibus standard method to detect positive signals.
METHODS: This retrospective observational study relied on adverse drug reactions reported to the FDA through FAERS, which is a standard public system for spontaneous reporting.
RESULTS: Collectively, 2171 AE reports for teprotumumab were collected, among which 108 significant signals were identified involving 17 system organ classes. The SOC of ear and labyrinth disorders included the most AE signals and reports. Muscle spasms, fatigue, headache, nausea, diarrhea, alopecia, blood glucose increased, hypoacusis, tinnitus, and diabetes mellitus were the top ten PTs ranked by the frequency of reporting, meanwhile, the two high-strength signals of thyroid-stimulating immunoglobulin increase (ROR 662.89, 95% CI 182.40-2409.19) and gingival recession (ROR 125.13, 95% CI 79.70-196.45) were not documented in the drug instruction. Meanwhile, we found a higher risk of increased blood glucose, deafness, and decreased appetite for male patients, and headache for female patients.
CONCLUSIONS: Clinical application of teprotumumab should be closely monitored for ototoxicity, nail abnormalities, and menstrual changes, as well as for AEs not mentioned in the drug instruction, including gingival recession, thyroid-stimulating immunoglobulin increase, and so on.
METHODS: The data obtained from the ASCII data packages in the FAERS database from January 2020 to the second quarter of 2023 were imported into the SAS software (version 9.4) for data cleaning and analysis. Disproportionality analysis was performed using the reporting odds ratio (ROR) in conjunction with the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) omnibus standard method to detect positive signals.
METHODS: This retrospective observational study relied on adverse drug reactions reported to the FDA through FAERS, which is a standard public system for spontaneous reporting.
RESULTS: Collectively, 2171 AE reports for teprotumumab were collected, among which 108 significant signals were identified involving 17 system organ classes. The SOC of ear and labyrinth disorders included the most AE signals and reports. Muscle spasms, fatigue, headache, nausea, diarrhea, alopecia, blood glucose increased, hypoacusis, tinnitus, and diabetes mellitus were the top ten PTs ranked by the frequency of reporting, meanwhile, the two high-strength signals of thyroid-stimulating immunoglobulin increase (ROR 662.89, 95% CI 182.40-2409.19) and gingival recession (ROR 125.13, 95% CI 79.70-196.45) were not documented in the drug instruction. Meanwhile, we found a higher risk of increased blood glucose, deafness, and decreased appetite for male patients, and headache for female patients.
CONCLUSIONS: Clinical application of teprotumumab should be closely monitored for ototoxicity, nail abnormalities, and menstrual changes, as well as for AEs not mentioned in the drug instruction, including gingival recession, thyroid-stimulating immunoglobulin increase, and so on.
摘要：
目的：Teprotumumab在甲状腺眼病的发病机制和进展中起重要作用。我们打算从相关数据库中挖掘不良事件（AE）信号，从而有助于teprotumumab的安全使用。
方法：将2020年1月至2023年第二季度从FAERS数据库中的ASCII数据包获得的数据导入到SAS软件（9.4版）中进行数据清理和分析。使用报告比值比（ROR）与英国药品和医疗保健产品监管机构（MHRA）综合标准方法进行比例分析，以检测阳性信号。
方法：这项回顾性观察研究依赖于通过FAERS向FDA报告的药物不良反应，这是自发报告的标准公共系统。
结果：总的来说，收集了2171份teprotumumab的不良事件报告，其中发现了108个重要信号，涉及17个系统器官类别。耳朵和迷宫障碍的SOC包括大多数AE信号和报告。肌肉痉挛,疲劳,头痛,恶心,腹泻,脱发,血糖升高,hypoacusis,耳鸣,和糖尿病是按报告频率排名的前十名PT，同时,药物说明书中没有记录甲状腺刺激免疫球蛋白增加(ROR662.89,95%CI182.40-2409.19)和牙龈萎缩(ROR125.13,95%CI79.70-196.45)的两个高强度信号.同时,我们发现血糖升高的风险更高，耳聋,男性患者的食欲下降，女性患者头痛。
结论：应密切监测teprotumumab的耳毒性，指甲异常,和月经的变化，以及药物说明书中未提及的不良事件，包括牙龈衰退，甲状腺刺激免疫球蛋白增加，等等。
方法：将2020年1月至2023年第二季度从FAERS数据库中的ASCII数据包获得的数据导入到SAS软件（9.4版）中进行数据清理和分析。使用报告比值比（ROR）与英国药品和医疗保健产品监管机构（MHRA）综合标准方法进行比例分析，以检测阳性信号。
方法：这项回顾性观察研究依赖于通过FAERS向FDA报告的药物不良反应，这是自发报告的标准公共系统。
结果：总的来说，收集了2171份teprotumumab的不良事件报告，其中发现了108个重要信号，涉及17个系统器官类别。耳朵和迷宫障碍的SOC包括大多数AE信号和报告。肌肉痉挛,疲劳,头痛,恶心,腹泻,脱发,血糖升高,hypoacusis,耳鸣,和糖尿病是按报告频率排名的前十名PT，同时,药物说明书中没有记录甲状腺刺激免疫球蛋白增加(ROR662.89,95%CI182.40-2409.19)和牙龈萎缩(ROR125.13,95%CI79.70-196.45)的两个高强度信号.同时,我们发现血糖升高的风险更高，耳聋,男性患者的食欲下降，女性患者头痛。
结论：应密切监测teprotumumab的耳毒性，指甲异常,和月经的变化，以及药物说明书中未提及的不良事件，包括牙龈衰退，甲状腺刺激免疫球蛋白增加，等等。
