Markle Jonathan C, Johanis Anil, Shaia Jacqueline K, Benito Daniel, Talcott Katherine E, Singh Rishi P
Center for Ophthalmic Bioinformatics, Cleveland Clinic, Cole Eye Institute, Cleveland, OH, USA.
Case Western Reserve School of Medicine, Cleveland, OH, USA.
Eye (Lond). 2025 Apr;39(6):1107-1114. doi: 10.1038/s41433-024-03531-1. Epub 2024 Dec 12.
BACKGROUND/OBJECTIVES: Patients with thyroid eye disease (TED) taking teprotumumab have reported audiologic symptoms as a side effect; however, limited real world data and large sample sizes have been utilized to evaluate this relationship.
A retrospective cohort study was created in TriNetX to identify patients with TED utilizing ICD-10, CPT, and Healthcare Common Procedure coding systems. TED patients with and without teprotumumab treatment were analysed with greedy one-to-one propensity matching. Appearance of one or more new ICD-10 codes corresponding to audiologic outcomes of interest (tinnitus, sensorineural hearing loss, hypoacusis, hyperacusis, autophony, Eustachian tube dysfunction) served as the outcome of interest. Patients with a history of hearing impairment were also evaluated for worsening hearing loss after initiation of teprotumumab.
Within the entire TriNetX cohort, 88 out of 441 patients with a diagnosis code for TED treated with teprotumumab had new appearance of an audiologic outcome within TriNetX. After matching, the relative risk for TED patients who were exposed to teprotumumab for new audiologic symptoms was increased with a risk ratio (RR) of 2.85 [95% CI 1.94, 4.20] compared to TED patients not exposed to teprotumumab. Of 51 patients with a history of hearing impairment and TED, 14 had record of new audiologic testing after teprotumumab administration (RR = 1.90 [0.96, 3.78]) compared to unexposed patients.
This study affirms previous research stating that TED patients receiving teprotumumab are at an increased risk of new audiologic side effects when compared to TED patients not using teprotumumab.
背景/目的:接受替普罗单抗治疗的甲状腺眼病(TED)患者报告出现听力症状作为副作用;然而,用于评估这种关系的真实世界数据有限且样本量较大。
在TriNetX中开展一项回顾性队列研究,利用国际疾病分类第十版(ICD - 10)、现行程序编码系统(CPT)和医疗通用程序编码系统识别TED患者。对接受和未接受替普罗单抗治疗的TED患者进行贪婪一对一倾向匹配分析。出现一个或多个与感兴趣的听力结果(耳鸣、感音神经性听力损失、听力减退、听觉过敏、自听增强、咽鼓管功能障碍)相对应的新ICD - 10编码作为感兴趣的结果。对有听力障碍病史的患者也评估了开始使用替普罗单抗后听力损失的恶化情况。
在整个TriNetX队列中,441例诊断为TED并接受替普罗单抗治疗的患者中有88例在TriNetX中出现了新的听力结果。匹配后,与未接受替普罗单抗治疗的TED患者相比,接受替普罗单抗治疗的TED患者出现新听力症状的相对风险增加,风险比(RR)为2.85 [95%置信区间1.94, 4.20]。在51例有听力障碍病史且患有TED的患者中,与未接受治疗的患者相比,14例在接受替普罗单抗治疗后有新的听力测试记录(RR = 1.90 [0.96, 3.78])。
本研究证实了先前的研究,即与未使用替普罗单抗的TED患者相比,接受替普罗单抗治疗的TED患者出现新的听力副作用的风险增加。