来自真实世界数据库的抗体药物偶联物的眼部不良事件及其与生存的关系。

IF 2.1 3区 医学 Q2 OPHTHALMOLOGY
Samuel H Kim, Rayna F Marshall, Karen M Wai, Ehsan Rahimy, Filippos Vingopoulos, Kapil Mishra, Meghan Berkenstock, Prithvi Mruthyunjaya
{"title":"来自真实世界数据库的抗体药物偶联物的眼部不良事件及其与生存的关系。","authors":"Samuel H Kim, Rayna F Marshall, Karen M Wai, Ehsan Rahimy, Filippos Vingopoulos, Kapil Mishra, Meghan Berkenstock, Prithvi Mruthyunjaya","doi":"10.1097/ICO.0000000000003997","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Ocular adverse events can be black box warning complications for antibody drug conjugates (ADCs), requiring ophthalmologic evaluation. Although extensive management and deescalation protocols are in place, association with overall survival for patients with ocular adverse events are unknown.</p><p><strong>Methods: </strong>Retrospective cohort study with data from deidentified aggregated electronic health records database. Inclusion criteria were prescription of ADCs, no prior recorded ocular symptoms, and the presence of a clinical visit after ADC initiation. Propensity score matching was used to control for demographic factors and cancer diagnoses.</p><p><strong>Results: </strong>A cohort of 14,138 patients with a mean age of 59 years (SD: 20y) was identified. Most common ocular adverse events were dry eyes (2.9%), keratitis or conjunctivitis (2.21%), uveitis (0.23%), and corneal ulcers (0.085%). Belantamab mafodotin had the highest rates of keratitis or conjunctivitis (17.8%). Patients without any ocular adverse events after ADC initiation had an increased risk of death [RR: 1.20, P = 0.0013] within 5 years compared with patients with ocular adverse events. Specifically, patients without keratitis or conjunctivitis after ADC initiation had an increased risk of death [RR: 1.43, P = 0.019] within 1 year.</p><p><strong>Conclusions: </strong>Uveitis and corneal ulcers were exceedingly rare for all ADCs. Patients on ADCs with ocular adverse events, compared with those without, had a decreased risk of death. As ophthalmologic management of patients on ADCs are becoming more prevalent, aggressive management of ocular adverse events may be warranted, when ADCs are effective, as ocular adverse events may portend better survival outcomes.</p>","PeriodicalId":10710,"journal":{"name":"Cornea","volume":" ","pages":""},"PeriodicalIF":2.1000,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Ocular Adverse Events of Antibody Drug Conjugates and Association With Survival From a Real-World Database.\",\"authors\":\"Samuel H Kim, Rayna F Marshall, Karen M Wai, Ehsan Rahimy, Filippos Vingopoulos, Kapil Mishra, Meghan Berkenstock, Prithvi Mruthyunjaya\",\"doi\":\"10.1097/ICO.0000000000003997\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Ocular adverse events can be black box warning complications for antibody drug conjugates (ADCs), requiring ophthalmologic evaluation. Although extensive management and deescalation protocols are in place, association with overall survival for patients with ocular adverse events are unknown.</p><p><strong>Methods: </strong>Retrospective cohort study with data from deidentified aggregated electronic health records database. Inclusion criteria were prescription of ADCs, no prior recorded ocular symptoms, and the presence of a clinical visit after ADC initiation. Propensity score matching was used to control for demographic factors and cancer diagnoses.</p><p><strong>Results: </strong>A cohort of 14,138 patients with a mean age of 59 years (SD: 20y) was identified. Most common ocular adverse events were dry eyes (2.9%), keratitis or conjunctivitis (2.21%), uveitis (0.23%), and corneal ulcers (0.085%). Belantamab mafodotin had the highest rates of keratitis or conjunctivitis (17.8%). Patients without any ocular adverse events after ADC initiation had an increased risk of death [RR: 1.20, P = 0.0013] within 5 years compared with patients with ocular adverse events. Specifically, patients without keratitis or conjunctivitis after ADC initiation had an increased risk of death [RR: 1.43, P = 0.019] within 1 year.</p><p><strong>Conclusions: </strong>Uveitis and corneal ulcers were exceedingly rare for all ADCs. Patients on ADCs with ocular adverse events, compared with those without, had a decreased risk of death. As ophthalmologic management of patients on ADCs are becoming more prevalent, aggressive management of ocular adverse events may be warranted, when ADCs are effective, as ocular adverse events may portend better survival outcomes.</p>\",\"PeriodicalId\":10710,\"journal\":{\"name\":\"Cornea\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2025-09-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cornea\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/ICO.0000000000003997\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cornea","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/ICO.0000000000003997","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

目的:抗体药物偶联物(adc)的眼部不良事件可能是黑盒警告并发症,需要眼科评估。虽然有广泛的管理和降级方案,但与眼部不良事件患者的总生存率的关系尚不清楚。方法:回顾性队列研究,数据来自未识别的汇总电子健康记录数据库。纳入标准为ADC处方,既往无眼部症状记录,ADC开始后存在临床就诊。倾向评分匹配用于控制人口因素和癌症诊断。结果:确定了14138例患者,平均年龄59岁(SD: 20岁)。最常见的眼部不良事件是干眼(2.9%)、角膜炎或结膜炎(2.21%)、葡萄膜炎(0.23%)和角膜溃疡(0.085%)。Belantamab mafodotin的角膜炎和结膜炎发生率最高(17.8%)。与有眼部不良事件的患者相比,ADC开始后无眼部不良事件的患者5年内死亡风险增加[RR: 1.20, P = 0.0013]。具体而言,ADC开始后无角膜炎或结膜炎的患者1年内死亡风险增加[RR: 1.43, P = 0.019]。结论:葡萄膜炎和角膜溃疡在所有adc中极为罕见。与没有眼部不良事件的患者相比,服用adc的患者死亡风险降低。随着adc患者的眼科治疗变得越来越普遍,当adc有效时,可能需要对眼部不良事件进行积极的管理,因为眼部不良事件可能预示着更好的生存结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Ocular Adverse Events of Antibody Drug Conjugates and Association With Survival From a Real-World Database.

Purpose: Ocular adverse events can be black box warning complications for antibody drug conjugates (ADCs), requiring ophthalmologic evaluation. Although extensive management and deescalation protocols are in place, association with overall survival for patients with ocular adverse events are unknown.

Methods: Retrospective cohort study with data from deidentified aggregated electronic health records database. Inclusion criteria were prescription of ADCs, no prior recorded ocular symptoms, and the presence of a clinical visit after ADC initiation. Propensity score matching was used to control for demographic factors and cancer diagnoses.

Results: A cohort of 14,138 patients with a mean age of 59 years (SD: 20y) was identified. Most common ocular adverse events were dry eyes (2.9%), keratitis or conjunctivitis (2.21%), uveitis (0.23%), and corneal ulcers (0.085%). Belantamab mafodotin had the highest rates of keratitis or conjunctivitis (17.8%). Patients without any ocular adverse events after ADC initiation had an increased risk of death [RR: 1.20, P = 0.0013] within 5 years compared with patients with ocular adverse events. Specifically, patients without keratitis or conjunctivitis after ADC initiation had an increased risk of death [RR: 1.43, P = 0.019] within 1 year.

Conclusions: Uveitis and corneal ulcers were exceedingly rare for all ADCs. Patients on ADCs with ocular adverse events, compared with those without, had a decreased risk of death. As ophthalmologic management of patients on ADCs are becoming more prevalent, aggressive management of ocular adverse events may be warranted, when ADCs are effective, as ocular adverse events may portend better survival outcomes.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Cornea
Cornea 医学-眼科学
CiteScore
5.20
自引率
10.70%
发文量
354
审稿时长
3-6 weeks
期刊介绍: For corneal specialists and for all general ophthalmologists with an interest in this exciting subspecialty, Cornea brings together the latest clinical and basic research on the cornea and the anterior segment of the eye. Each volume is peer-reviewed by Cornea''s board of world-renowned experts and fully indexed in archival format. Your subscription brings you the latest developments in your field and a growing library of valuable professional references. Sponsored by The Cornea Society which was founded as the Castroviejo Cornea Society in 1975.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信