{"title":"生物仿制药 Ranibizumab (OPTIMAB®) 与创新药 Ranibizumab 对新生血管性（湿性）年龄相关性黄斑变性患者的疗效和安全性对比：一项双盲、随机、多中心 III 期研究。","authors":"Parth J Rana, Himanshu Deshmukh, Urmil Shah, Vinod Kumar, Sanghamitra Kanungo, Deepika Singhal, Santosh Kumar Mahapatra, Ira Vakharia, Mukesh Jaiswal, Ajitkumar Gondane, Pooja Vaidya, Vinayaka Shahavi, Harish Shandilya, Dattatray Pawar, Akhilesh Sharma","doi":"10.2147/OPTH.S488866","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to compare efficacy, safety, and immunogenicity of the biosimilar ranibizumab in comparison with the Innovator Ranibizumab in treatment-naive patients with neovascular (wet) age-related macular degeneration (nAMD or wAMD).</p><p><strong>Materials and methods: </strong>This comparative, double blind, multicentre, Phase III clinical study randomized eligible patients in a 3:1 ratio to receive either OPTIMAB<sup>®</sup> (Alkem Laboratories Ltd./ Enzene Biosciences Ltd.) or Innovator Ranibizumab. Intravitreal injections of Innovator Ranibizumab (0.5 mg in 0.05 mL) and OPTIMAB<sup>®</sup> (0.5 mg in 0.05 mL) were administered every four weeks for 12 weeks (three doses). Primary efficacy endpoints included loss of <15 letters from baseline, gain of ≥15 letters from baseline in visual acuity, mean change in best corrected visual acuity (BCVA) from baseline, and change in central subfoveal thickness (CSFT) from baseline at week 12. Safety was assessed through monitoring of adverse events (AEs) and serious adverse events (SAEs) throughout the study.</p><p><strong>Results: </strong>Overall, of the 152 patients randomized, 141 (92.8%) patients (mean age, 66.6 ± 9.37 years) completed the study. Percentage of patients who lost < 15 letters in BCVA at week 12 from baseline was comparable in both the groups (100.0%, each). On secondary end point analysis, the two groups had comparable mean changes in BCVA (OPTIMAB<sup>®</sup>, 11.8 ± 9.18; innovator ranibizumab, 12.9 ± 10.29; P = 0.5509); proportion of patients who gained ≥ 15 letters in visual acuity (OPTIMAB<sup>®</sup>, 32.18%; innovator ranibizumab, 25.74%; P = 0.4785) and mean change in CSFT (OPTIMAB<sup>®</sup>, -76.6 ± 89.03; Innovator ranibizumab, -73.1 ± 92.23 μm; P = 0.8422) at week 12 as compared to baseline. OPTIMAB<sup>®</sup> and innovator ranibizumab demonstrated comparable safety over the 12-week treatment period and no patient expressed anti-ranibizumab antibody in either group patient.</p><p><strong>Conclusion: </strong>Biosimilar ranibizumab (OPTIMAB<sup>®</sup>) was non-inferior to innovator ranibizumab in terms of efficacy, safety, and immunogenicity in the patients of nAMD.</p>","PeriodicalId":93945,"journal":{"name":"Clinical ophthalmology (Auckland, N.Z.)","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11531239/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Biosimilar Ranibizumab (OPTIMAB<sup>®</sup>) <i>versus</i> Innovator Ranibizumab in Patients with Neovascular (Wet) Age-Related Macular Degeneration: A Double-Blind, Randomized, Multicenter, Phase III Study.\",\"authors\":\"Parth J Rana, Himanshu Deshmukh, Urmil Shah, Vinod Kumar, Sanghamitra Kanungo, Deepika Singhal, Santosh Kumar Mahapatra, Ira Vakharia, Mukesh Jaiswal, Ajitkumar Gondane, Pooja Vaidya, Vinayaka Shahavi, Harish Shandilya, Dattatray Pawar, Akhilesh Sharma\",\"doi\":\"10.2147/OPTH.S488866\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>This study aimed to compare efficacy, safety, and immunogenicity of the biosimilar ranibizumab in comparison with the Innovator Ranibizumab in treatment-naive patients with neovascular (wet) age-related macular degeneration (nAMD or wAMD).</p><p><strong>Materials and methods: </strong>This comparative, double blind, multicentre, Phase III clinical study randomized eligible patients in a 3:1 ratio to receive either OPTIMAB<sup>®</sup> (Alkem Laboratories Ltd./ Enzene Biosciences Ltd.) or Innovator Ranibizumab. Intravitreal injections of Innovator Ranibizumab (0.5 mg in 0.05 mL) and OPTIMAB<sup>®</sup> (0.5 mg in 0.05 mL) were administered every four weeks for 12 weeks (three doses). Primary efficacy endpoints included loss of <15 letters from baseline, gain of ≥15 letters from baseline in visual acuity, mean change in best corrected visual acuity (BCVA) from baseline, and change in central subfoveal thickness (CSFT) from baseline at week 12. Safety was assessed through monitoring of adverse events (AEs) and serious adverse events (SAEs) throughout the study.</p><p><strong>Results: </strong>Overall, of the 152 patients randomized, 141 (92.8%) patients (mean age, 66.6 ± 9.37 years) completed the study. Percentage of patients who lost < 15 letters in BCVA at week 12 from baseline was comparable in both the groups (100.0%, each). On secondary end point analysis, the two groups had comparable mean changes in BCVA (OPTIMAB<sup>®</sup>, 11.8 ± 9.18; innovator ranibizumab, 12.9 ± 10.29; P = 0.5509); proportion of patients who gained ≥ 15 letters in visual acuity (OPTIMAB<sup>®</sup>, 32.18%; innovator ranibizumab, 25.74%; P = 0.4785) and mean change in CSFT (OPTIMAB<sup>®</sup>, -76.6 ± 89.03; Innovator ranibizumab, -73.1 ± 92.23 μm; P = 0.8422) at week 12 as compared to baseline. OPTIMAB<sup>®</sup> and innovator ranibizumab demonstrated comparable safety over the 12-week treatment period and no patient expressed anti-ranibizumab antibody in either group patient.</p><p><strong>Conclusion: </strong>Biosimilar ranibizumab (OPTIMAB<sup>®</sup>) was non-inferior to innovator ranibizumab in terms of efficacy, safety, and immunogenicity in the patients of nAMD.</p>\",\"PeriodicalId\":93945,\"journal\":{\"name\":\"Clinical ophthalmology (Auckland, N.Z.)\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-10-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11531239/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical ophthalmology (Auckland, N.Z.)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2147/OPTH.S488866\",\"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.S488866","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}
Efficacy and Safety of Biosimilar Ranibizumab (OPTIMAB®) versus Innovator Ranibizumab in Patients with Neovascular (Wet) Age-Related Macular Degeneration: A Double-Blind, Randomized, Multicenter, Phase III Study.
Objective: This study aimed to compare efficacy, safety, and immunogenicity of the biosimilar ranibizumab in comparison with the Innovator Ranibizumab in treatment-naive patients with neovascular (wet) age-related macular degeneration (nAMD or wAMD).
Materials and methods: This comparative, double blind, multicentre, Phase III clinical study randomized eligible patients in a 3:1 ratio to receive either OPTIMAB® (Alkem Laboratories Ltd./ Enzene Biosciences Ltd.) or Innovator Ranibizumab. Intravitreal injections of Innovator Ranibizumab (0.5 mg in 0.05 mL) and OPTIMAB® (0.5 mg in 0.05 mL) were administered every four weeks for 12 weeks (three doses). Primary efficacy endpoints included loss of <15 letters from baseline, gain of ≥15 letters from baseline in visual acuity, mean change in best corrected visual acuity (BCVA) from baseline, and change in central subfoveal thickness (CSFT) from baseline at week 12. Safety was assessed through monitoring of adverse events (AEs) and serious adverse events (SAEs) throughout the study.
Results: Overall, of the 152 patients randomized, 141 (92.8%) patients (mean age, 66.6 ± 9.37 years) completed the study. Percentage of patients who lost < 15 letters in BCVA at week 12 from baseline was comparable in both the groups (100.0%, each). On secondary end point analysis, the two groups had comparable mean changes in BCVA (OPTIMAB®, 11.8 ± 9.18; innovator ranibizumab, 12.9 ± 10.29; P = 0.5509); proportion of patients who gained ≥ 15 letters in visual acuity (OPTIMAB®, 32.18%; innovator ranibizumab, 25.74%; P = 0.4785) and mean change in CSFT (OPTIMAB®, -76.6 ± 89.03; Innovator ranibizumab, -73.1 ± 92.23 μm; P = 0.8422) at week 12 as compared to baseline. OPTIMAB® and innovator ranibizumab demonstrated comparable safety over the 12-week treatment period and no patient expressed anti-ranibizumab antibody in either group patient.
Conclusion: Biosimilar ranibizumab (OPTIMAB®) was non-inferior to innovator ranibizumab in terms of efficacy, safety, and immunogenicity in the patients of nAMD.
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