生物类似药雷珠单抗（OPTIMAB）与原研雷珠单抗治疗新生血管性（湿性）年龄相关性黄斑变性患者的疗效和安全性：一项双盲、随机、多中心、III期研究
Efficacy and Safety of Biosimilar Ranibizumab (OPTIMAB) Innovator Ranibizumab in Patients with Neovascular (Wet) Age-Related Macular Degeneration: A Double-Blind, Randomized, Multicenter, Phase III Study.
作者信息
Rana Parth J, Deshmukh Himanshu, Shah Urmil, Kumar Vinod, Kanungo Sanghamitra, Singhal Deepika, Mahapatra Santosh Kumar, Vakharia Ira, Jaiswal Mukesh, Gondane Ajitkumar, Vaidya Pooja, Shahavi Vinayaka, Shandilya Harish, Pawar Dattatray, Sharma Akhilesh
机构信息
Department of Retina and Trauma Surgery, Netralaya Superspeciallity Hospital, Ahmedabad, Gujarat, India.
Department of Retina; 'Daulat' Deshmukh Eye Hospital, Khaparde Gardens, Amravati, Maharashtra, India.
出版信息
Clin Ophthalmol. 2024 Oct 29;18:3071-3081. doi: 10.2147/OPTH.S488866. eCollection 2024.
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.
目的
本研究旨在比较生物类似药雷珠单抗与原研雷珠单抗在初治新生血管性（湿性）年龄相关性黄斑变性（nAMD或wAMD）患者中的疗效、安全性和免疫原性。
材料与方法
这项比较性、双盲、多中心III期临床研究将符合条件的患者按3:1的比例随机分组，分别接受OPTIMAB（阿尔凯姆实验室有限公司/恩泽生物科学有限公司）或原研雷珠单抗治疗。每四周玻璃体内注射一次原研雷珠单抗（0.5毫克，溶于0.05毫升）和OPTIMAB（0.5毫克，溶于0.05毫升），共注射12周（三剂）。主要疗效终点包括与基线相比视力下降<15个字母、视力较基线提高≥15个字母、最佳矫正视力（BCVA）较基线的平均变化以及第12周时中心凹下厚度（CSFT）较基线的变化。在整个研究过程中，通过监测不良事件（AE）和严重不良事件（SAE）来评估安全性。
结果
总体而言，152例随机分组的患者中，141例（92.8%）患者（平均年龄66.6±9.37岁）完成了研究。两组中在第12周时BCVA较基线下降<15个字母的患者百分比相当（均为100.0%）。在次要终点分析中，两组的BCVA平均变化相当（OPTIMAB为11.8±9.18；原研雷珠单抗为12.9±10.29；P = 0.5509）；第12周时视力提高≥15个字母的患者比例（OPTIMAB为32.18%；原研雷珠单抗为25.74%；P = 0.4785）以及CSFT较基线的平均变化（OPTIMAB为-76.6±89.03；原研雷珠单抗为-73.1±92.23微米；P = 0.8422）。在12周的治疗期内，OPTIMAB和原研雷珠单抗的安全性相当，两组患者均未出现抗雷珠单抗抗体。
结论
在nAMD患者中，生物类似药雷珠单抗（OPTIMAB）在疗效、安全性和免疫原性方面不劣于原研雷珠单抗。
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