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布罗鲁单抗治疗新生血管性年龄相关性黄斑变性患者的短期治疗结果:一项印度多中心真实世界证据研究。

Short-Term Treatment Outcomes of Brolucizumab in Patients with Neovascular Age-Related Macular Degeneration: A Multicentre Indian Real-World Evidence Study.

作者信息

Chakraborty Debdulal, Thakkar Milan, Venkatesh Ramesh, Roy Sangeeta, Bhavsar Maulik, Karcher Helene

机构信息

Disha Eye Hospital, Kolkata, West Bengal, India.

Dr. Milan's Retina Care Centre, Rajkot, Gujarat, India.

出版信息

Clin Ophthalmol. 2023 Aug 10;17:2295-2307. doi: 10.2147/OPTH.S415044. eCollection 2023.

Abstract

OBJECTIVE

To evaluate the short-term effectiveness and safety outcomes following brolucizumab treatment in patients with neovascular age-related macular degeneration (nAMD) as a part of real-world clinical practice in India.

METHODS

This was a retrospective, observational, multicentre study including patients (≥50 years old) diagnosed with nAMD. Anonymized data of the patients receiving the first dose of brolucizumab intravitreal injection (IVI) who were either treatment-naïve or previously treated with a single or a combination of other anti-VEGF IVIs were included. The present study reported the change in retinal fluid levels from baseline to month 3, best-corrected visual acuity (BCVA), central retinal thickness (CRT), and the number of injections received. The adverse events in the three months after brolucizumab treatment initiation were also monitored.

RESULTS

The study included 63 patients (65 eyes) from four study centres across India (mean age: 69.1 ± 9.7 years). A total of 82 brolucizumab injections were administered during the 3 months of study duration, with 52/65 (80.0%) eyes receiving only 1 injection. Resolution of IRF, SRF, and PED was observed in 76.9%, 64.6%, and 67.7% of eyes, respectively. Further, a significant reduction in CRT was observed (baseline: 403.5 ± 118.7 μm; month 3: 308.3 ± 73.8 μm; p < 0.001), and BCVA also improved notably from 0.7 ± 0.5 logMAR at baseline to 0.5 ± 0.4 logMAR at month 3 (p < 0.001). Adverse events (AEs) were reported in 3 eyes from 3 patients; retinal pigment epithelial rip (1) and subretinal hemorrhage (2) after the first injection of brolucizumab, however, none discontinued the treatment.

CONCLUSION

The study reports on the short-term effectiveness and tolerability of brolucizumab therapy in the management of nAMD in both treatment-naïve and switch eyes. Brolucizumab was observed to have a favourable benefit-risk profile, and study results were within the known safety profile, with no instances of intraocular inflammation.

摘要

目的

评估在印度现实世界临床实践中,布罗卢单抗治疗新生血管性年龄相关性黄斑变性(nAMD)患者后的短期有效性和安全性结果。

方法

这是一项回顾性、观察性、多中心研究,纳入了被诊断为nAMD的患者(≥50岁)。纳入了首次接受布罗卢单抗玻璃体内注射(IVI)的患者的匿名数据,这些患者要么是初治患者,要么之前接受过单一或其他抗VEGF玻璃体内注射的联合治疗。本研究报告了从基线到第3个月视网膜液水平的变化、最佳矫正视力(BCVA)、中心视网膜厚度(CRT)以及接受注射的次数。还监测了布罗卢单抗治疗开始后三个月内的不良事件。

结果

该研究纳入了来自印度四个研究中心的63例患者(65只眼)(平均年龄:69.1±9.7岁)。在研究持续的3个月内共进行了82次布罗卢单抗注射,65只眼中有52只(80.0%)仅接受了1次注射。分别在76.9%、64.6%和67.7%的眼中观察到视网膜内液(IRF)、视网膜下液(SRF)和色素上皮脱离(PED)的消退。此外,观察到CRT显著降低(基线:403.5±118.7μm;第3个月:308.3±73.8μm;p<0.001),BCVA也从基线时的0.7±0.5 logMAR显著提高到第3个月时的0.5±0.4 logMAR(p<0.001)。3例患者的3只眼中报告了不良事件(AE);首次注射布罗卢单抗后出现视网膜色素上皮撕裂(1例)和视网膜下出血(2例),然而,没有人停止治疗。

结论

该研究报告了布罗卢单抗治疗在初治和转换治疗的nAMD患者管理中的短期有效性和耐受性。观察到布罗卢单抗具有良好的获益风险比,研究结果在已知的安全范围内,未出现眼内炎症情况。

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