Park Hyo Song, Lee Seung Won, Park Hyunjin, Lee Nang Kyeong, Kim Yong Joon, Lee Christopher Seungkyu, Byeon Suk Ho, Kim Sung Soo
Department of Ophthalmology, College of Medicine, Soonchunhyang University, Cheonan, South Korea.
Department of Ophthalmology, Soonchunhyang University Hospital Bucheon, Bucheon, South Korea.
Sci Rep. 2024 Oct 2;14(1):22913. doi: 10.1038/s41598-024-73782-1.
This study aimed to evaluate the incidence of clinically significant intraocular inflammation (csIOI) after treatment with intravitreal injection (IVI) of brolucizumab and identify csIOI risk factors. We categorized 60,966 South Korean patients from a nationwide population-based cohort into 4 groups: groups 1 (Ranibizumab), 2 (Aflibercept), 3 (Brolucizumab), and 4 (switched to brolucizumab). We used the Kaplan-Meier method to estimate the cumulative incidence of csIOI in each group and calculated the hazard ratios (HRs) and 95% confidence intervals (CIs). We constructed a multivariate model using forward selection methods to identify risk factors for csIOI. The cumulative incidence of csIOI within 180 days of the index date in groups 1, 2, 3, and 4 was 0.36% (67/18,537), 0.49% (186/37,951), 3.47% (38/1,095), and 3.69% (125/3,383), respectively. Multivariate analysis revealed a significant increase in csIOI risk in groups 3 (HR 11.08, 95% CI 7.42-16.53, P < 0.001) and 4 (HR 10.40, 95% CI 7.67-14.09, P < 0.001). History of retinal vascular occlusion (HR 1.56, 95% CI 1.01-2.40, P = 0.043) significantly increased csIOI risk after brolucizumab IVI treatment; female sex (HR 0.78, 95% CI 0.64-0.96, p = 0.020) and diabetes (HR 0.72, 95% CI 0.58-0.90, p = 0.004) decreased the risk. csIOI incidence was higher after brolucizumab IVI treatment than after ranibizumab and aflibercept IVI treatment. Retinal vein occlusion history, female sex, and diabetes are associated with csIOI after brolucizumab IVI treatment.
本研究旨在评估玻璃体内注射布罗珠单抗治疗后临床上显著的眼内炎症（csIOI）的发生率，并确定csIOI的危险因素。我们将来自韩国全国基于人群队列的60966例患者分为4组：第1组（雷珠单抗）、第2组（阿柏西普）、第3组（布罗珠单抗）和第4组（转换为布罗珠单抗）。我们使用Kaplan-Meier方法估计每组中csIOI的累积发生率，并计算风险比（HRs）和95%置信区间（CIs）。我们使用向前选择法构建多变量模型以识别csIOI的危险因素。在索引日期后180天内，第1、2、3和4组中csIOI的累积发生率分别为0.36%（67/18537）、0.49%（186/37951）、3.47%（38/1095）和3.69%（125/3383）。多变量分析显示，第3组（HR 11.08，95%CI 7.42-16.53，P＜0.001）和第4组（HR 10.40，95%CI 7.67-14.09，P＜0.001）的csIOI风险显著增加。视网膜血管阻塞病史（HR 1.56，95%CI 1.01-2.40，P = 0.043）在布罗珠单抗玻璃体内注射治疗后显著增加csIOI风险；女性（HR 0.78，95%CI 0.64-0.96，P = 0.020）和糖尿病（HR 0.72，95%CI 0.58-0.90，P = 0.004）降低风险。布罗珠单抗玻璃体内注射治疗后的csIOI发生率高于雷珠单抗和阿柏西普玻璃体内注射治疗后。视网膜静脉阻塞病史、女性和糖尿病与布罗珠单抗玻璃体内注射治疗后的csIOI相关。
