{"title":"糖尿病性黄斑水肿（DME）从阿非利西普过渡到生物类似药雷尼单抗：（TRANSFORM-DME试验）一项多中心观察研究。","authors":"Debdulal Chakraborty, Tushar Kanti Sinha, Aniruddha Maiti, Subhendu Kumar Boral, Arnab Das, Soumen Mondal, Krishnendu Nandi, Ranabir Bhattacharya","doi":"10.2147/OPTH.S500912","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate visual and anatomical outcomes following a switch from intravitreal Aflibercept (IVI AFL) (T1) to biosimilar Ranibizumab (B-RBZ) (T2) in patients with diabetic macular edema (DME).</p><p><strong>Methods: </strong>This was a multicenter observational study, analysing medical records of consecutive, treatment-naïve centre-involving DME patients having a baseline visual acuity (VA) of ≥55 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. DME patients, having received monthly loading doses of IVI AFL(T1) and responsive to it, who subsequently shifted to B-RBZ(T2) motivated by financial constraints rather than a lack of efficacy to IVI AFL were identified.</p><p><strong>Results: </strong>This study included 57 participants (mean age: 54.23 ± 6.91 years), with 80.7% male patients. VA improved during T1, from 61.4 ± 11.74 ETDRS letters at baseline to 72.7 ± 8.05 ETDRS letters (mean change: +11.2 letters, 95% CI: 9.1 to 13.4; p < 0.001). During T2, VA declined slightly over 12 months with a mean VA of 69.9 ± 3.78 ETDRS letters at the 12-month mark (+8.5 letters from baseline; p < 0.001). Mean central macular thickness (CMT) during T1 reduced from 411.9 ± 34.62 μm at baseline to 279.3 ± 9.96 μm (mean change: -132.6 μm, 95% CI: -142.2 to -122.9 μm; p < 0.001). CMT remained stable over the 12-month follow-up period, with minimal fluctuations. Subretinal fluid (SRF) and intra retinal fluid (IRF) were present in 84.2% and 91.2% of eyes, respectively, decreasing to 5.3% and 7.0% at the time of switch (p < 0.001). In T2 phase, 22.8% and 21.1% exhibited SRF and IRF, respectively, at the end of the study.</p><p><strong>Conclusion: </strong>Transitioning to biosimilar Ranibizumab (Razumab) after initial treatment with aflibercept in patients with DME preserved visual and anatomical benefits over a 12-month period, with only minor variations in SRF and IRF. These results underscore the efficacy of biosimilar Ranibizumab as a cost-effective option for managing DME.</p>","PeriodicalId":93945,"journal":{"name":"Clinical ophthalmology (Auckland, N.Z.)","volume":"18 ","pages":"3449-3456"},"PeriodicalIF":0.0000,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11606343/pdf/","citationCount":"0","resultStr":"{\"title\":\"Transitioning from Aflibercept to Biosimilar Ranibizumab in Diabetic Macular Edema (DME): (The TRANSFORM-DME Trial) a Multicenter Observational Study.\",\"authors\":\"Debdulal Chakraborty, Tushar Kanti Sinha, Aniruddha Maiti, Subhendu Kumar Boral, Arnab Das, Soumen Mondal, Krishnendu Nandi, Ranabir Bhattacharya\",\"doi\":\"10.2147/OPTH.S500912\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>To evaluate visual and anatomical outcomes following a switch from intravitreal Aflibercept (IVI AFL) (T1) to biosimilar Ranibizumab (B-RBZ) (T2) in patients with diabetic macular edema (DME).</p><p><strong>Methods: </strong>This was a multicenter observational study, analysing medical records of consecutive, treatment-naïve centre-involving DME patients having a baseline visual acuity (VA) of ≥55 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. DME patients, having received monthly loading doses of IVI AFL(T1) and responsive to it, who subsequently shifted to B-RBZ(T2) motivated by financial constraints rather than a lack of efficacy to IVI AFL were identified.</p><p><strong>Results: </strong>This study included 57 participants (mean age: 54.23 ± 6.91 years), with 80.7% male patients. VA improved during T1, from 61.4 ± 11.74 ETDRS letters at baseline to 72.7 ± 8.05 ETDRS letters (mean change: +11.2 letters, 95% CI: 9.1 to 13.4; p < 0.001). During T2, VA declined slightly over 12 months with a mean VA of 69.9 ± 3.78 ETDRS letters at the 12-month mark (+8.5 letters from baseline; p < 0.001). Mean central macular thickness (CMT) during T1 reduced from 411.9 ± 34.62 μm at baseline to 279.3 ± 9.96 μm (mean change: -132.6 μm, 95% CI: -142.2 to -122.9 μm; p < 0.001). CMT remained stable over the 12-month follow-up period, with minimal fluctuations. Subretinal fluid (SRF) and intra retinal fluid (IRF) were present in 84.2% and 91.2% of eyes, respectively, decreasing to 5.3% and 7.0% at the time of switch (p < 0.001). In T2 phase, 22.8% and 21.1% exhibited SRF and IRF, respectively, at the end of the study.</p><p><strong>Conclusion: </strong>Transitioning to biosimilar Ranibizumab (Razumab) after initial treatment with aflibercept in patients with DME preserved visual and anatomical benefits over a 12-month period, with only minor variations in SRF and IRF. These results underscore the efficacy of biosimilar Ranibizumab as a cost-effective option for managing DME.</p>\",\"PeriodicalId\":93945,\"journal\":{\"name\":\"Clinical ophthalmology (Auckland, N.Z.)\",\"volume\":\"18 \",\"pages\":\"3449-3456\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-11-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11606343/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical ophthalmology (Auckland, N.Z.)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2147/OPTH.S500912\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical ophthalmology (Auckland, N.Z.)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/OPTH.S500912","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
Transitioning from Aflibercept to Biosimilar Ranibizumab in Diabetic Macular Edema (DME): (The TRANSFORM-DME Trial) a Multicenter Observational Study.
Purpose: To evaluate visual and anatomical outcomes following a switch from intravitreal Aflibercept (IVI AFL) (T1) to biosimilar Ranibizumab (B-RBZ) (T2) in patients with diabetic macular edema (DME).
Methods: This was a multicenter observational study, analysing medical records of consecutive, treatment-naïve centre-involving DME patients having a baseline visual acuity (VA) of ≥55 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. DME patients, having received monthly loading doses of IVI AFL(T1) and responsive to it, who subsequently shifted to B-RBZ(T2) motivated by financial constraints rather than a lack of efficacy to IVI AFL were identified.
Results: This study included 57 participants (mean age: 54.23 ± 6.91 years), with 80.7% male patients. VA improved during T1, from 61.4 ± 11.74 ETDRS letters at baseline to 72.7 ± 8.05 ETDRS letters (mean change: +11.2 letters, 95% CI: 9.1 to 13.4; p < 0.001). During T2, VA declined slightly over 12 months with a mean VA of 69.9 ± 3.78 ETDRS letters at the 12-month mark (+8.5 letters from baseline; p < 0.001). Mean central macular thickness (CMT) during T1 reduced from 411.9 ± 34.62 μm at baseline to 279.3 ± 9.96 μm (mean change: -132.6 μm, 95% CI: -142.2 to -122.9 μm; p < 0.001). CMT remained stable over the 12-month follow-up period, with minimal fluctuations. Subretinal fluid (SRF) and intra retinal fluid (IRF) were present in 84.2% and 91.2% of eyes, respectively, decreasing to 5.3% and 7.0% at the time of switch (p < 0.001). In T2 phase, 22.8% and 21.1% exhibited SRF and IRF, respectively, at the end of the study.
Conclusion: Transitioning to biosimilar Ranibizumab (Razumab) after initial treatment with aflibercept in patients with DME preserved visual and anatomical benefits over a 12-month period, with only minor variations in SRF and IRF. These results underscore the efficacy of biosimilar Ranibizumab as a cost-effective option for managing DME.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
