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与法西单抗治疗相关的眼内炎症:一年真实世界结果

INTRAOCULAR INFLAMMATION ASSOCIATED WITH FARICIMAB THERAPY: One-Year Real-World Outcomes.

作者信息

Montesel Andrea, Sen Sagnik, Preston Ella, Patel Praveen J, Huemer Josef, Hamilton Robin D, Nicholson Luke, Papasavvas Ioannis, Tucker William R, Yeung Ian

机构信息

Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom.

NIHR Biomedical Research Centre, UCL Institute of Ophthalmology, London, United Kingdom.

出版信息

Retina. 2025 May 1;45(5):827-832. doi: 10.1097/IAE.0000000000004394.

Abstract

PURPOSE

To report 1-year real-world evidence on intraocular inflammation (IOI) adverse events in patients undergoing faricimab therapy in a tertiary care hospital.

METHODS

A retrospective review of electronic medical records was conducted for patients receiving faricimab treatment for neovascular age-related macular degeneration and diabetic macular edema at Moorfields Eye Hospital between September 1, 2022, and August 31, 2023. The primary outcome was the incidence of IOI (excluding endophthalmitis).

RESULTS

Two thousand three hundred and eighteen eyes from 1,860 patients were included and underwent a total of 10,297 injections. A total of 20 eyes (16 patients) had ≥1 adverse event of IOI. Estimated incidence of IOI was 0.19% per injection (95% confidence interval, 0.12-0.30), 0.86% per eye (95% confidence interval 0.53-1.33), and 0.86% per patient (95% confidence interval, 0.49-1.39). Intraocular inflammation mostly occurred within the first injections (median 3.5 injections, range 1-10). All cases presented with anterior uveitis and were associated with vitritis in four eyes (20%). No cases of posterior uveitis or evidence of retinal vascular occlusion were reported. There was no statistically significant difference between the mean visual acuity before and after IOI event (0.40 and 0.378 logarithm of minimum angle of resolution, respectively, P = 0.26).

CONCLUSION

In this real-world report, faricimab was well tolerated with an incidence of IOI-related adverse events consistent to that observed in registration trials. The adverse events were generally mild and had a favorable prognosis.

摘要

目的

报告在一家三级护理医院接受法西单抗治疗的患者中眼内炎症(IOI)不良事件的1年真实世界证据。

方法

对2022年9月1日至2023年8月31日期间在摩尔菲尔德眼科医院接受法西单抗治疗新生血管性年龄相关性黄斑变性和糖尿病性黄斑水肿的患者的电子病历进行回顾性研究。主要结局是IOI(不包括眼内炎)的发生率。

结果

纳入了1860例患者的2318只眼,共进行了10297次注射。共有20只眼(16例患者)发生了≥1次IOI不良事件。IOI的估计发生率为每次注射0.19%(95%置信区间,0.12 - 0.30),每只眼0.86%(95%置信区间0.53 - 1.33),每位患者0.86%(95%置信区间,0.49 - 1.39)。眼内炎症大多发生在首次注射期间(中位数3.5次注射,范围1 - 10次)。所有病例均表现为前葡萄膜炎,4只眼(20%)伴有玻璃体炎。未报告后葡萄膜炎病例或视网膜血管阻塞的证据。IOI事件前后的平均视力之间无统计学显著差异(分别为最小分辨角对数的0.40和0.378,P = 0.26)。

结论

在本真实世界报告中,法西单抗耐受性良好,IOI相关不良事件的发生率与注册试验中观察到的一致。不良事件一般较轻,预后良好。

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