雷尼珠单抗生物类似药(Razumab®)的安全性和有效性,作为现实世界中黄斑疾病创新分子的成本效益替代品

Sonal Paliwal, Riddhima Deshpande, Prerna Upadhyay
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引用次数: 0

摘要

为了报告玻璃体内雷尼单抗生物类似药分子的临床疗效和安全性,Razumab®(IVRz)作为创新分子(Lucentis)在现实世界条件下治疗黄斑疾病的经济替代品。一项单中心前瞻性研究,在2020年4月至2021年3月期间,连续100只眼睛接受3个月的IVRz治疗各种黄斑疾病,包括糖尿病性黄斑水肿(DME)、新生血管性黄斑变性(nAMD)、视网膜静脉阻塞(RVO)和近视脉络膜新生血管膜(mCNVM)。主要结果测量是最佳矫正视力(BCVA)、中心亚野厚度(CST)、视网膜内液(IRF)和视网膜下液(SRF)的变化以及分别在第4周、第8周和第12周的安全性分析。: 100例IVRz患者的100只眼中,大多数有DME(39只眼;39%),其次是RVO(34眼;34%), nAMD(21眼;21%), mCNVM(6眼;6%). 平均BCVA从基线到第4、8和12周均有所改善(P<0.001)。在所有就诊中也注意到CST从基线显著降低(P<0.001)。定性分析显示,SRF分辨率为61.47%,IRF分辨率为61.71%。未发现严重的眼部或全身不良事件。我们的实际数据表明,IVRz治疗对于各种黄斑病变的治疗是安全有效的。这种经监管部门批准的生物仿制药的成本效益、系统和眼部安全性使其成为品牌药物的合适替代品。为了更好地了解抗血管内皮生长因子(anti-VEGF)治疗绒毛膜视网膜疾病的健康经济学,有必要对这些生物仿制药和品牌药的收益-成本分析进行进一步的比较研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety and efficacy of ranibizumab biosimilar (Razumab®) as a cost-effective alternative to the innovator molecule for macular disorders in real-world
: To report the clinical efficacy and safety of the intravitreal ranibizumab biosimilar molecule, Razumab® (IVRz) as an economic alternative to the innovator molecule (Lucentis) in macular diseases under real-world conditions. : A single‑ center, prospective study of 100 consecutive eyes undergoing three-monthly IVRz between April 2020 to March 2021 for a variety of macular disorders including diabetic macular edema (DME), neovascular age‑related macular degeneration (nAMD), retinal vein occlusion (RVO), and myopic choroidal neovascular membrane (mCNVM). The main outcome measures were changes in best-corrected visual acuity (BCVA), central subfield thickness (CST), intraretinal-fluid (IRF), and subretinal-fluid (SRF) along with a safety analysis at weeks 4, 8, and 12 respectively. : Of the 100 eyes of 100 patients undergoing IVRz, a majority had DME (39 eyes; 39%) followed by RVO (34 eyes; 34%), nAMD (21 eyes; 21%), and mCNVM (6 eyes; 6%). Mean BCVA improved from baseline to weeks 4, 8, and 12 (P&#60;0.001). A significant reduction in CST from the baseline was also noted at all the visits (P&#60;0.001). On qualitative analysis, resolution of SRF and IRF was observed in 61.47% and 61.71% of eyes respectively. No serious ocular or systemic adverse events were noted. : Our real-world data suggests that IVRz therapy is safe and efficacious for the management of varied macular pathologies. The cost-effectiveness and systemic and ocular safety of this regulatory-approved biosimilar makes it a suitable alternative to the branded drug. Further comparative studies into the benefit-cost analysis of these biosimilar and branded agents are warranted to better understand the health economics of anti-vascular endothelial growth factor (anti-VEGF) therapy in chorioretinal disorders.
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