Department of Ophthalmology, Stein Eye Institute, David Geffen School of Medicine at the University of California at Los Angeles, Los Angeles, California.
American Academy of Ophthalmology, San Francisco, California.
Ophthalmology. 2021 Jun;128(6):910-919. doi: 10.1016/j.ophtha.2020.11.001. Epub 2020 Nov 6.
Detailed study of ophthalmic immune-related adverse events (AEs), including determination of incidence and recurrence rates, is of integral importance in cancer immunotherapy to inform management and treatment guidelines.
Retrospective registry study.
Patients newly diagnosed with ophthalmic immune-related AEs between January 1, 2013, and December 31, 2017, in the American Academy of Ophthalmology's Intelligent Research in Sight (IRIS®) Registry.
Data were collected from electronic health records of IRIS® Registry participating ophthalmology practices. Patients with select ophthalmic immune-related AEs were identified by International Classification of Diseases diagnosis codes. The primary exposure of interest was prior initiation of immune checkpoint inhibitors (ICIs).
Incidence of ophthalmic immune-related AEs within 1 year after initiation of ICI therapy was determined. Incidence rate ratios (IRRs) were derived by comparing incidence of ophthalmic immune-related AEs after ICIs versus rates of the same ocular complications in patients not taking ICIs in the entire registry population. Rates of ophthalmic immune-related AEs in patients with a past history of ocular inflammation or other specific ophthalmic condition before initiation of ICIs were examined further.
A total of 3123 patients who received anti-CTLA-4 or anti-programmed cell death 1 (PD-1) therapy were identified, 112 of whom demonstrated an ophthalmic immune-related AE. Incidence rates for anterior uveitis, the most common ophthalmic immune-related AE, were 8209 per 100 000 for ipilimumab (anti-CTLA-4), 2542 per 100 000 for nivolumab (anti-PD-1), 2451 per 100 000 for pembrolizumab (anti-PD-1), 5556 per 100 000 for ipilimumab plus nivolumab, and 3740 per 100 000 among all ICIs. Rates of ophthalmic immune-related AEs among patients receiving ICI therapy were higher compared with baseline rates in the general registry population (anterior uveitis IRR, 13.9; other uveitis IRR, 43.0; papilledema IRR, 38.3). Patients with a history of uveitis or other ocular inflammatory condition demonstrated high recurrence rates of ophthalmic immune-related AEs after initiating ICIs (up to 51.1%).
For patients initiating ICI therapy, early coordination with ophthalmic subspecialist care is important because rates of ophthalmic immune-related AEs are elevated compared with ocular complication rates in the entire registry population and patients with a history of prior autoimmune ocular disease are at high risk of recurrence of ocular complications.
详细研究眼部免疫相关不良事件（AEs），包括确定发病率和复发率，对于癌症免疫疗法至关重要，可据此制定管理和治疗指南。
回顾性注册研究。
2013 年 1 月 1 日至 2017 年 12 月 31 日期间，在美国眼科学会的智能研究视野（IRIS®）注册中心新诊断为眼部免疫相关 AEs 的患者。
从 IRIS®Registry 参与眼科实践的电子健康记录中收集数据。通过国际疾病分类诊断代码识别特定眼部免疫相关 AEs 的患者。主要暴露因素为免疫检查点抑制剂（ICIs）的初始应用。
ICI 治疗后 1 年内眼部免疫相关 AEs 的发生率。通过比较 ICIs 治疗后眼部免疫相关 AEs 的发生率与整个登记人群中未接受 ICI 治疗的患者出现相同眼部并发症的发生率，得出发病率比（IRR）。进一步检查了在开始使用 ICI 之前有眼部炎症或其他特定眼部疾病史的患者的眼部免疫相关 AEs 发生率。
共确定了 3123 例接受抗 CTLA-4 或抗程序性细胞死亡 1（PD-1）治疗的患者，其中 112 例出现眼部免疫相关 AE。前部葡萄膜炎是最常见的眼部免疫相关 AE，发生率分别为依匹单抗（抗 CTLA-4）8209/100000，纳武单抗（抗 PD-1）2542/100000，帕博利珠单抗（抗 PD-1）2451/100000，依匹单抗联合纳武单抗 5556/100000，所有 ICI 药物 3740/100000。与一般登记人群的基线发生率相比，接受 ICI 治疗的患者发生眼部免疫相关 AEs 的比率更高（前部葡萄膜炎 IRR，13.9；其他葡萄膜炎 IRR，43.0；视盘水肿 IRR，38.3）。有葡萄膜炎或其他眼部炎症病史的患者在开始使用 ICI 后眼部免疫相关 AEs 的复发率很高（高达 51.1%）。
对于开始接受 ICI 治疗的患者，与眼科专家进行早期协调非常重要，因为与整个登记人群的眼部并发症发生率相比，眼部免疫相关 AEs 的发生率较高，且有既往自身免疫性眼病史的患者眼部并发症复发的风险很高。
