Real-world experience with brolucizumab in neovascular age-related macular degeneration over 2 years: the REBA extension study

Alper Bilgic, Laurent Kodjikian, Francesc March de Ribot, Martin S. Spitzer, Vaishali Vasavada, Jesus Hernan Gonzalez-Cortes, Aditya Sudhalkar, Somnath Chakraborty, Thibaud Mathis
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Abstract

Background

To determine long-term efficacy and safety of intravitreal brolucizumab therapy for neovascular age-related macular degeneration (nAMD) in the real-world setting.

Methods

Retrospective, observational, multicentric study and an extension of the REBA study (Real-world Experience with Brolucizumab in nAMD) to 24 months. The study entailed follow-up of 91 consecutive eyes (67 patients) with nAMD who received brolucizumab therapy and completed 24 months of follow-up. Both treatment-naïve and switch therapy patients were included. All relevant data were collected. The primary outcome measure was changed in best-corrected visual acuity (BCVA) over time. Secondary outcome measures included change in central subfield thickness (CST) and complications.

Results

The mean (SD) baseline BCVA was 48.4 (3.5) letters and 36.2 (7.1) letters in treatment-naïve group and switch therapy group, respectively. BCVA gain was + 9.2 (3.7) letters (p = 0.01) and + 7.7 (3.4) letters (p = 0.011), respectively. The change in mean (SD) CST has shown a significant decrease in retinal thickness in treatment-naïve group (from 432.5 (68.4) to 283.0 (51.3) µm; p = 0.018) and in switch therapy group (from 452.5 (40.5) to 271.0 (43.4) µm; p = 0.011) group. One switch patient developed vascular occlusion and another a macular hole after the fifth brolucizumab injection as reported in the primary study. Both patients recovered uneventfully. Three patients demonstrated reversible intraocular inflammation between months 10 and 24.

Conclusion

Patients showed a significant anatomical and functional response to brolucizumab therapy in the real world, regardless of prior treatment status, until the end of the follow-up period. Overall, 5 significant untoward events were noted.

Abstract Image

布鲁珠单抗治疗新生血管性老年黄斑变性两年多的真实体验:REBA 扩展研究
背景确定在真实世界环境中,静脉内布卢单抗治疗新生血管性年龄相关性黄斑变性(nAMD)的长期疗效和安全性。方法回顾性、观察性、多中心研究,并将 REBA 研究(Real-world Experience with Brolucizumab in nAMD)延长至 24 个月。该研究对接受过布卢单抗治疗并完成 24 个月随访的 91 例 nAMD 患者(67 例)进行了随访。研究对象既包括未接受治疗的患者,也包括转换治疗的患者。所有相关数据均已收集。主要结局指标是最佳矫正视力(BCVA)随时间的变化。结果治疗无效组和转换疗法组的基线 BCVA 平均值(标度)分别为 48.4 (3.5) 个字母和 36.2 (7.1) 个字母。BCVA 增益分别为 + 9.2 (3.7) 个字母 (p = 0.01) 和 + 7.7 (3.4) 个字母 (p = 0.011)。平均(标清)CST 的变化显示,治疗无效组(从 432.5 (68.4) 微米降至 283.0 (51.3) 微米;p = 0.018)和转换治疗组(从 452.5 (40.5) 微米降至 271.0 (43.4) 微米;p = 0.011)视网膜厚度显著下降。一名换药患者在注射第五次博路单抗后出现了血管闭塞,另一名患者在注射第五次博路单抗后出现了黄斑孔,这在主要研究中已有报告。这两名患者均顺利康复。结论无论之前的治疗情况如何,直到随访期结束,患者在真实世界中对布卢单抗治疗都表现出了显著的解剖和功能反应。总体而言,共发生了5起重大意外事件。
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