Importance Limited data exist on the real-world safety outcomes of patients with neovascular age-related macular degeneration treated with brolucizumab (Beovu).

Objective To determine the real-world incidence of intraocular inflammation (IOI), including retinal vasculitis (RV) and/or retinal vascular occlusion (RO), for patients with neovascular age-related macular degeneration who underwent brolucizumab treatment. Additionally, potential risk factors associated with these adverse events were evaluated.

Design, Setting, and Participants This cohort study included patients with neovascular age-related macular degeneration in the Intelligent Research in Sight (IRIS) Registry and Komodo Healthcare Map. Patients initiating and receiving 1 or more brolucizumab injections from October 8, 2019, to June 5, 2020, with up to 6 months of follow-up were included.

Intervention Brolucizumab injections.

Main Outcome and Measures Incidence of IOI (including RV) and/or RO and RV and/or RO and risk stratification for the identified risk factors.

Results Of 10 654 and 11 161 included eyes (from the IRIS Registry and Komodo Health database, respectively), the median follow-up times were 97 and 95 days. Most eyes switched from another anti–vascular endothelial growth factor agent (9686 of 10 654 [90.9%] and 10 487 of 11 161 [94.0%], respectively), most commonly aflibercept (7160 of 9686 [73.9%] and 7156 of 10 487 [68.2%]), and most were from women (6105 of 10 654 [57.3%] and 6452 of 11 161 [57.8%]). The overall incidence of IOI and/or RO was 2.4% (255 of 10 654 eyes) and 2.4% (268 of 11 161 eyes) for the IRIS and Komodo groups, respectively, and RV and/or RO, 0.6% (59 of 10 654 eyes and 63 of 11 161 eyes), respectively. Patients with a history of IOI and/or RO in the 12 months before brolucizumab initiation had an increased observed risk rate (8.7% [95% CI, 6.0%-11.4%] and 10.6% [95% CI, 7.5%-13.7%]) for an IOI and/or RO event in the 6 months following the first brolucizumab treatment compared with patients without prior IOI and/or RO (2.0% in both data sets). There was an increased estimated incidence rate in women (2.9% [95% CI, 2.5%-3.3%] and 3.0% [95% CI, 2.6%-3.4%]) compared with men (1.3% [95% CI, 1.0%-1.7%] and 1.4% [95% CI, 1.0%-1.7%]), but this risk was not as large as that of a prior IOI and/or RO. Similar findings were observed for patients with RV and/or RO events.

Conclusions and Relevance The incidence rate of IOI and/or RO was approximately 2.4%. Patient eyes with IOI and/or RO in the 12 months prior to first brolucizumab injection had the highest observed risk rate for IOI and/or RO in the early months after the first brolucizumab treatment. However, given study limitations, the identified risk factors cannot be used as predictors of IOI and/or RO events, and causality with brolucizumab cannot be assessed.

重要性 使用 brolucizumab (Beovu) 治疗的新生血管性年龄相关性黄斑变性患者的真实世界安全性结果数据有限。

目的 确定接受 brolucizumab 治疗的新生血管性年龄相关性黄斑变性患者眼内炎症 (IOI) 的真实发生率，包括视网膜血管炎 (RV) 和/或视网膜血管阻塞 (RO)。此外，还评估了与这些不良事件相关的潜在风险因素。

设计、设置和参与者 该队列研究包括智能视力研究 (IRIS) 登记和科莫多医疗地图中患有新生血管性年龄相关性黄斑变性的患者。纳入从 2019 年 10 月 8 日至 2020 年 6 月 5 日期间开始并接受 1 次或多次 brolucizumab 注射的患者，随访时间最长为 6 个月。

干预 Brolucizumab 注射。

主要结果和测量 IOI（包括 RV）和/或 RO 和 RV 和/或 RO 的发生率以及已识别风险因素的风险分层。

结果 在 10 654 只和 11 161 只眼睛中（分别来自 IRIS Registry 和 Komodo Health 数据库），中位随访时间分别为 97 天和 95 天。大多数眼睛从另一种抗血管内皮生长因子药物转换（分别为 10 654 例中的 9686 例 [90.9%] 和 11 161 例中的 10 487 例 [94.0%]），最常见的是阿柏西普（9686 例中的 7160 例 [73.9%] 和 10 例中的​​ 7156 例） 487 [68.2%]），大多数来自女性（10 654 人中有 6105 人 [57.3%] 和 11 161 人中有 6452 人 [57.8%]）。IRIS 和 Komodo 组的 IOI 和/或 RO 的总发生率分别为 2.4%（10 654 只眼中的 255 只）和 2.4%（11 161 只眼中的 268 只），而 RV 和/或 RO，0.6%（59 只眼） 10 654 只眼和 11 161 只眼中的 63 只），分别。在 brolucizumab 开始前 12 个月内有 IOI 和/或 RO 病史的患者观察到的风险率增加（8.7% [95% CI, 6.0%-11.4%] 和 10.6% [95% CI, 7.5%-13. 7%]）在第一次 brolucizumab 治疗后 6 个月内发生 IOI 和/或 RO 事件，与之前没有 IOI 和/或 RO 的患者相比（两个数据集中均为 2.0%）。与男性（1.3% [95% CI, 1.0 %-1.7%] 和 1.4% [95% CI, 1.0%-1.7%]），但这种风险没有之前的 IOI 和/或 RO 大。对于 RV 和/或 RO 事件的患者也观察到了类似的结果。但这种风险没有之前的 IOI 和/或 RO 大。对于 RV 和/或 RO 事件的患者也观察到了类似的结果。但这种风险没有之前的 IOI 和/或 RO 大。对于 RV 和/或 RO 事件的患者也观察到了类似的结果。

结论和相关性 IOI 和/或 RO 的发生率约为 2.4%。在第一次 brolucizumab 注射前 12 个月内患有 IOI 和/或 RO 的患者眼睛在第一次 brolucizumab 治疗后的最初几个月观察到的 IOI 和/或 RO 风险率最高。然而，鉴于研究限制，已确定的风险因素不能用作 IOI 和/或 RO 事件的预测因子，也无法评估与 brolucizumab 的因果关系。