{"title":"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","authors":"Sonal Paliwal, Riddhima Deshpande, Prerna Upadhyay","doi":"10.18231/j.ijceo.2023.062","DOIUrl":null,"url":null,"abstract":": 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<0.001). A significant reduction in CST from the baseline was also noted at all the visits (P<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.","PeriodicalId":13485,"journal":{"name":"Indian Journal of Clinical and Experimental Ophthalmology","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety and efficacy of ranibizumab biosimilar (Razumab®) as a cost-effective alternative to the innovator molecule for macular disorders in real-world\",\"authors\":\"Sonal Paliwal, Riddhima Deshpande, Prerna Upadhyay\",\"doi\":\"10.18231/j.ijceo.2023.062\",\"DOIUrl\":null,\"url\":null,\"abstract\":\": 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<0.001). A significant reduction in CST from the baseline was also noted at all the visits (P<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.\",\"PeriodicalId\":13485,\"journal\":{\"name\":\"Indian Journal of Clinical and Experimental Ophthalmology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-09-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Indian Journal of Clinical and Experimental Ophthalmology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.18231/j.ijceo.2023.062\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Indian Journal of Clinical and Experimental Ophthalmology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.18231/j.ijceo.2023.062","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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<0.001). A significant reduction in CST from the baseline was also noted at all the visits (P<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.