Chuan Junlan, Liu Lianqiao, Feng Yumei, Wang Mengdan, Li Gang, Lv Qin
Department of Pharmacy, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
Personalized Drug Therapy Key Laboratory of Sichuan Province, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
Front Pharmacol. 2022 May 13;13:890732. doi: 10.3389/fphar.2022.890732. eCollection 2022.
As demonstrated in pivotal clinical trials, brolucizumab can be used to treat neovascular age-related macular degeneration (nAMD) because it antagonizes vascular endothelial growth factor (VEGF) in the vitreous. However, brolucizumab may cause retinal vasculitis obliterans in the presence of inflammation in the eyes. In the present study, a meta-analysis of randomized controlled trials (RCTs) was conducted to evaluate the efficacy and safety of brolucizumab. ClinicTrail.gov., Embase, Cochrane Library, and PubMed were retrieved from inception until 31 December 2021 for RCTs assessing the efficacy and safety of brolucizumab. Changes in best corrected visual acuity (BCVA) and central sub-field thickness (CSFT) and incidence of adverse events, serious adverse events, and serious ocular adverse events were extracted from eligible RCTs. A meta-analysis was performed using RevMan 5.4.1. A total of six RCTs with 3,574 participants were finally involved in this meta-analysis. The changes of best corrected visual acuity (BCVA) showed no statistically significant difference between the brolucizumab-treated group and aflibercept-treated group. Brolucizumab induced higher central sub-field thickness (CSFT) reduction than the control agent (aflibercept). The incidence of adverse events was similar between the brolucizumab group and control group (OR 0.63, 95% CI 0.37 to 1.08, = 0.09), and brolucizumab caused fewer serious adverse events (OR 0.78, 95% CI 0.63 to 0.95, = 0.01). However, brolucizumab could lead to more serious ocular adverse events than Lucentis and aflibercept (OR 2.15, 95% CI 1.11 to 4.16, = 0.02). Brolucizumab was non-inferior to other anti-VEGF agents in improving BCVA and decreasing CSFT. But it caused more serious ocular adverse events which is worthy of special attention by ophthalmologists.
如在关键临床试验中所证明的，布罗芦izumab可用于治疗新生血管性年龄相关性黄斑变性（nAMD），因为它可拮抗玻璃体内的血管内皮生长因子（VEGF）。然而，在眼部存在炎症的情况下，布罗芦izumab可能会导致视网膜血管闭塞性血管炎。在本研究中，进行了一项随机对照试验（RCT）的荟萃分析，以评估布罗芦izumab的疗效和安全性。从ClinicalTrials.gov、Embase、Cochrane图书馆和PubMed数据库建库至2021年12月31日检索评估布罗芦izumab疗效和安全性的RCT。从符合条件的RCT中提取最佳矫正视力（BCVA）和中心子野厚度（CSFT）的变化以及不良事件、严重不良事件和严重眼部不良事件的发生率。使用RevMan 5.4.1进行荟萃分析。最终共有6项RCT、3574名参与者纳入本荟萃分析。最佳矫正视力（BCVA）的变化在布罗芦izumab治疗组和阿柏西普治疗组之间无统计学显著差异。布罗芦izumab比对照药物（阿柏西普）诱导的中心子野厚度（CSFT）降低幅度更大。布罗芦izumab组和对照组之间不良事件的发生率相似（OR 0.63，95%CI 0.37至1.08，P = 0.09），且布罗芦izumab引起的严重不良事件较少（OR 0.78，95%CI 0.63至0.95，P = 0.01）。然而，布罗芦izumab可能比雷珠单抗和阿柏西普导致更多严重眼部不良事件（OR 2.15，95%CI 1.11至4.16，P = 0.02）。布罗芦izumab在改善BCVA和降低CSFT方面不劣于其他抗VEGF药物。但它会导致更多严重眼部不良事件，值得眼科医生特别关注。
