Evaluation of uveitis events in real-world patients receiving immune checkpoint inhibitors based on the FAERS database.

IF 1.6 4区 医学 Q3 OPHTHALMOLOGY Cutaneous and Ocular Toxicology Pub Date : 2023-06-01 DOI:10.1080/15569527.2023.2208661
Qianqian Fan, Huan Chen, Yang Hu, Bin Zhao
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Abstract

Purpose: Immune checkpoint inhibitors (ICIs) have emerged as a novel class of drugs carrying a potential risk of uveitis. Due to the rarity, current knowledge on this safety issue is still incomplete. This study employed the post-marketing surveillance data to comprehensively describe and assess the uveitis events after the use of ICIs.

Methods: Data between 2004 and 2021 were downloaded from the Food and Drug Administration Adverse Event Reporting System (FAERS), and the uveitis events reported for ICIs were identified and included in this study. Clinical details of these reports were collected and analysed. Four data mining methods were utilised to investigate the potential associations between uveitis and different ICI regimens.

Results: Overall, 461 uveitis cases after exposure to ICI therapies were reported. Melanoma (58.79%) was revealed as the most common indication for receiving ICIs. The median onset time of uveitis was 41 (interquartile range 18-91) days after ICI initiation. 9.54% of these cases resulted in disability. Data mining results showed 5 ICIs generated positive uveitis signals when used alone. Ipilimumab yielded the most noticeable uveitis signal with the highest reporting odds ratio (ROR = 6.73, 95% two-sided CI = 5.26, 8.60), proportional reporting ratio (PRR = 6.69, χ2=308.52), information component (IC = 2.74, IC025 = 2.14) and empirical Bayes geometric mean (EBGM = 6.66, EBGM05 = 5.42), followed by pembrolizumab, cemiplimab, nivolumab and atezolizumab. When nivolumab, pembrolizumab or atezolizumab was administrated together with ipilimumab, obviously stronger uveitis signal was detected than that for either of them.

Conclusions: This study provided an overview of the clinical features of ICI-related uveitis cases in the FAERS. Data mining results revealed that positive uveitis signals commonly existed within this drug class, but signal strength varied among ICIs. When ICIs were used in a combined way, uveitis signals became obviously stronger. Therefore, early ophthalmic monitoring is important when applying ICIs to patients, especially those with a tendency for uveitis, such as melanoma patients.

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基于FAERS数据库评估接受免疫检查点抑制剂的现实患者的葡萄膜炎事件。
目的:免疫检查点抑制剂(ICIs)已成为一类具有潜在葡萄膜炎风险的新型药物。由于罕见,目前对这一安全问题的认识仍然不完整。本研究采用上市后的监测数据来全面描述和评估使用ICIs后的葡萄膜炎事件。方法:从美国食品药品监督管理局不良事件报告系统(FAERS)中下载2004年至2021年的数据,对报告的ICIs葡萄膜炎事件进行识别并纳入本研究。收集并分析这些报告的临床细节。使用四种数据挖掘方法来调查葡萄膜炎与不同ICI治疗方案之间的潜在关联。结果:总共报告了461例暴露于ICI治疗后的葡萄膜炎病例。黑色素瘤(58.79%)是接受ICIs的最常见适应症。葡萄膜炎的中位发病时间为ICI开始后41天(四分位数范围18-91)。9.54%的病例导致残疾。数据挖掘结果显示,5个ICIs单独使用时产生阳性葡萄膜炎信号。伊匹单抗产生葡萄膜炎信号最明显,报告优势比最高(ROR = 6.73, 95%双侧CI = 5.26, 8.60),比例报告比最高(PRR = 6.69, χ2=308.52),信息成分最高(IC = 2.74, IC025 = 2.14),经验贝叶斯几何平均最高(EBGM = 6.66, EBGM05 = 5.42),其次是派姆单抗、塞米单抗、纳武单抗和阿特唑单抗。当纳武单抗、派姆单抗或阿特唑单抗与伊匹利单抗合用时,检测到的葡萄膜炎信号明显强于单用。结论:本研究概述了FAERS中ici相关葡萄膜炎病例的临床特征。数据挖掘结果显示,葡萄膜炎阳性信号在这类药物中普遍存在,但信号强度在不同的ICIs中有所不同。当ICIs联合使用时,葡萄膜炎信号明显增强。因此,在对患者应用ICIs时,早期眼科监测非常重要,特别是那些有葡萄膜炎倾向的患者,如黑色素瘤患者。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
3.30
自引率
6.20%
发文量
40
审稿时长
1 months
期刊介绍: Cutaneous and Ocular Toxicology is an international, peer-reviewed journal that covers all types of harm to cutaneous and ocular systems. Areas of particular interest include pharmaceutical and medical products; consumer, personal care, and household products; and issues in environmental and occupational exposures. In addition to original research papers, reviews and short communications are invited, as well as concise, relevant, and critical reviews of topics of contemporary significance.
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