Biosimilar Ranibizumab (Ranieyes) Safety and Efficacy in the Real World: BRESER Study.

IF 0.5 Q4 OPHTHALMOLOGY
Ashish Sharma, Frank G Holz, Nilesh Kumar, David Sarraf, Seemantini Ayachit, Chitaranjan Mishra, Adnan Tufail, Debdulal Chakraborty, Aleksandra Rachitskaya, David Eichenbaum, Alay Banker, Nikulaa Parachuri, Ashish Kumar, Anat Loewenstein, Francesco Bandello, Taku Wakabayashi, Se Joon Woo, Baruch D Kuppermann
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Abstract

Purpose: To evaluate the early real-world clinical outcomes regarding the safety and efficacy after administration of a ranibizumab biosimilar (Ranieyes). Methods: This multicenter retrospective uncontrolled observational study incorporated data from 7 centers in India. All patients were treated with at least 1 intravitreal injection of 0.5 mg of ranibizumab biosimilar between July 2022 and July 2023 for various indications. Results: A total of 474 ranibizumab biosimilar injections were given in 268 eyes of 254 patients. Indications were diabetic macular edema (DME) (n = 112), macular neovascularization (MNV) (n = 92), retinal vein occlusion (RVO) (n = 54), cystoid macular edema (n = 4), and proliferative diabetic retinopathy with vitreous hemorrhage (n = 6). The mean logMAR BCVA (±SD) improved significantly from baseline to the last follow-up as follows: DME cases, from 0.77 ± 0.37 (Snellen equivalent, 6/36) to 0.43 ± 0.25 (6/15) (z = -8.0; r = -0.8); MNV cases, from 0.95 ± 0.53 (6/60) to 0.59 ± 0.42 (6/24) (z = -7.1; r = -0.8); RVO cases, from 0.83 ± 0.40 (6/45) to 0.44 ± 0.32 (6/15) (z = -5.5; r = -0.8) (all P < .001). All groups also had significant improvement in the central subfield thickness (all P < .001). No site reported drug-related adverse events (eg, inflammation, vasculitis, systemic adverse effects). Conclusions: The preliminary real-world data from this limited early series suggest that Ranieyes has clinical efficacy and is safe as a ranibizumab biosimilar across the approved indications.

生物仿制药雷尼单抗(Ranieyes)在现实世界中的安全性和有效性:BRESER研究。
目的:评估雷尼单抗生物类似药(Ranieyes)给药后的安全性和有效性的早期现实世界临床结果。方法:这项多中心回顾性非对照观察性研究纳入了印度7个中心的数据。所有患者在2022年7月至2023年7月期间接受了至少1次0.5 mg雷尼单抗生物类似药的玻璃体内注射治疗,用于各种适应症。结果:254例患者268只眼共接受474次雷尼单抗生物类似药注射。适应症为糖尿病性黄斑水肿(DME) (n = 112),黄斑新生血管(MNV) (n = 92),视网膜静脉闭塞(RVO) (n = 54),囊样黄斑水肿(n = 4),增殖性糖尿病视网膜病变合并玻璃体出血(n = 6)。从基线到最后一次随访,平均logMAR BCVA(±SD)显著改善如下:DME病例从0.77±0.37 (Snellen等效,6/36)到0.43±0.25 (6/15)(z = -8.0;R = -0.8);MNV病例数从0.95±0.53(6/60)至0.59±0.42 (6/24)(z = -7.1;R = -0.8);RVO病例,从0.83±0.40(6/45)到0.44±0.32 (6/15)(z = -5.5;r = -0.8)(均P < 0.001)。各组中心子野厚度均有显著改善(P < 0.001)。未发现与药物相关的不良事件(如炎症、血管炎、全身不良反应)。结论:来自有限的早期系列的初步真实世界数据表明,Ranieyes作为雷尼单抗生物类似药具有临床疗效,并且在批准的适应症中是安全的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
1.20
自引率
16.70%
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0
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