Giunta Michel, Gauvin Meunier Louis-Pierre, Nixon Donald, Steeves Jeff, Noble Jason
GOGiunta Ophtalmologie, Sherbrooke, QC, Canada.
Department of Surgery, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.
Clin Ophthalmol. 2022 Aug 30;16:2885-2894. doi: 10.2147/OPTH.S376199. eCollection 2022.
To assess early real-world outcomes with brolucizumab in Canadian patients with neovascular age-related macular degeneration (nAMD) for which they previously received ≥1 anti-vascular endothelial growth factor (anti-VEGF) agent(s).
This multisite, real-world, retrospective chart review included data from a consecutive sample of 73 patients who received brolucizumab for nAMD after treatment with ≥1 other anti-VEGF agents. The principal reasons for switching to brolucizumab were to extend the treatment interval (51.6% of patients) and to treat persistent macular fluid (34.2%). The primary outcomes were best-corrected visual acuity (BCVA) and the incidence rates of intraocular inflammation (IOI), retinal vasculitis (RV), and retinal vascular occlusion (RVO). Secondary outcomes included central retinal thickness (CRT), injection interval, and presence of intraretinal and subretinal fluid (IRF and SRF). All parameters were measured at baseline until the last treatment visit between April 27, 2020, and August 31, 2021.
Over a mean follow-up of 28 weeks, a nonsignificant mean improvement in BCVA was identified (4.3 [standard deviation (SD) 8.3] letters; =0.057), with 47.9% experiencing a gain of ≥5 letters. IOI was detected in 3 patients (4.1%), one of whom also developed RV and RVO (1.4%), which is consistent with existing brolucizumab data. Significant reductions were observed in mean CRT (-36.6 μm [SD 56.1 μm]; =0.0002) and presence of any macular fluid (56.1% [SD 5.6%]; <0.001), IRF (66.6% [SD 6.3%]; <0.001), and SRF (62.7% [SD 6.3%]; <0.001). The mean injection interval increased significantly by 2.1 weeks (SD 2.7; <0.001).
In the first real-world Canadian analysis, brolucizumab was associated with improvements in functional outcomes in treatment-experienced patients, consistent with other real-world studies. The incidence of IOI, RV, and RVO were in line with the post hoc safety analysis of HAWK and HARRIER data.
评估在加拿大新血管性年龄相关性黄斑变性(nAMD)患者中,布罗卢单抗的早期真实世界疗效,这些患者此前接受过≥1种抗血管内皮生长因子(anti-VEGF)药物治疗。
这项多中心、真实世界、回顾性病历审查纳入了73例患者的连续样本数据,这些患者在接受≥1种其他抗VEGF药物治疗后,因nAMD接受了布罗卢单抗治疗。改用布罗卢单抗的主要原因是延长治疗间隔(51.6%的患者)和治疗持续性黄斑积液(34.2%)。主要结局指标为最佳矫正视力(BCVA)、眼内炎症(IOI)、视网膜血管炎(RV)和视网膜血管阻塞(RVO)的发生率。次要结局指标包括中心视网膜厚度(CRT)、注射间隔以及视网膜内和视网膜下积液(IRF和SRF)的存在情况。所有参数均在基线时进行测量,直至2020年4月27日至2021年8月31日的最后一次治疗随访。
在平均28周的随访中,BCVA有非显著的平均改善(4.3 [标准差(SD)8.3] 字母;P = 0.057),47.9%的患者视力提高≥5字母。3例患者(4.1%)检测到IOI,其中1例还发生了RV和RVO(1.4%),这与现有的布罗卢单抗数据一致。平均CRT显著降低(-36.6 μm [SD 56.1 μm];P = 0.0002),任何黄斑积液的存在率(56.1% [SD 5.6%];P < 0.001)、IRF(66.6% [SD 6.3%];P < 0.001)和SRF(62.7% [SD 6.3%];P < 0.001)均显著降低。平均注射间隔显著增加2.1周(SD 2.7;P < 0.001)。
在加拿大首次真实世界分析中,布罗卢单抗与有治疗经验患者的功能结局改善相关,与其他真实世界研究一致。IOI、RV和RVO的发生率与HAWK和HARRIER数据的事后安全性分析结果相符。