Efficacy, Safety and Immunogenicity of Sun's Ranibizumab Biosimilar in Neovascular Age-Related Macular Degeneration: A Phase 3, Double-Blind Comparative Study.

IF 2.6 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2024-05-01 Epub Date: 2024-03-26 DOI:10.1007/s40123-024-00883-5

Asim K Ghosh, Usha S Nikumbh, Chaitanya K Shukla, Rohit S Laul, Abhishek Dixit, Santosh K Mahapatra, Sameera Nayak, Urmil M Shah, Sandeep Parwal, Narendran Venkatapathy, Natasha Radhakrishnan, Anup Kelgaonkar, Sandeep Saxena, Divyansh Mishra, Vivek Pravin Dave, Perwez Khan, Manojkumar R Saswade, Malli S Shantilal, Kim Ramasamy, Smitha Sreekanta, Mandodari Rajurkar, Maulik Doshi, Sapan Behera, Piyush Patel, Shilpi Dhawan, Lalit Lakhwani

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引用次数: 0

Abstract

Introduction: The study aimed to evaluate comparability in terms of efficacy, safety and immunogenicity of Sun's ranibizumab biosimilar with reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD).

Methods: This prospective, randomised, double-blind, two-group, parallel-arm, multicentre, phase 3 comparative study included patients with nAMD ≥ 50 years, randomised (in a 2:1 ratio) in a double-blind manner to receive 0.5 mg (0.05 mL) intravitreal injection of either Sun's ranibizumab or reference ranibizumab in the study eye every 4 weeks until week 16 (total of four doses).

Results: Primary endpoint results demonstrated equivalence in the proportion of patients who lost fewer than 15 letters from baseline best-corrected visual acuity (BCVA) to the end of week 16 (99% of patients in Sun's ranibizumab and 100% in reference ranibizumab; p > 0.9999), with the proportional difference (90% confidence interval) at -1% (-2.51, +0.61) lying within a pre-specified equivalence margin. Visual acuity improved by 15 or more letters in 43% of Sun's ranibizumab group and 37% of the reference ranibizumab group (p = 0.4267). The mean increase in BCVA was 15.7 letters in Sun's ranibizumab group and 14.6 letters in the reference ranibizumab group (p < 0.001 within both groups and p = 0.5275 between groups). The mean change in central macular thickness was comparable between groups (p = 0.7946). Anti-ranibizumab antibodies were found in one patient of the reference ranibizumab group, while neutralising antibodies were not found in any patients. Both products were well tolerated.

Conclusion: Sun's ranibizumab biosimilar is found to be therapeutically equivalent to reference ranibizumab in patients with nAMD. There were no additional safety or immunogenicity concerns.

Trial registration: CTRI/2020/09/027629, registered on 07 September 2020.

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Sun 公司的雷珠单抗生物类似物对新生血管性老年性黄斑变性的疗效、安全性和免疫原性：3期双盲比较研究》。

研究简介该研究旨在评估 Sun 公司的雷尼珠单抗生物类似物与参考雷尼珠单抗在新生血管性老年黄斑变性（nAMD）患者中的疗效、安全性和免疫原性的可比性：这项前瞻性、随机、双盲、两组、平行臂、多中心、3期比较研究纳入了年龄≥50岁的nAMD患者，以双盲方式随机（2:1的比例）在研究眼内接受0.5毫克（0.05毫升）Sun公司的雷尼珠单抗或参考雷尼珠单抗的玻璃体内注射，每4周一次，直至第16周（共4次）：主要终点结果显示，从基线最佳校正视力（BCVA）下降少于15个字母的患者比例与第16周结束时的结果相当（99%的患者使用了Sun's ranibizumab，100%的患者使用了参比的ranibizumab；P > 0.9999），比例差异（90%置信区间）为-1% (-2.51, +0.61)，在预先指定的等效范围内。43%的孙氏雷尼珠单抗组和37%的参考雷尼珠单抗组患者视力提高了15个或更多字母（P = 0.4267）。孙氏雷尼单抗组的 BCVA 平均增加 15.7 个字母，参考雷尼单抗组的 BCVA 平均增加 14.6 个字母（p 结论：孙氏雷尼单抗组的 BCVA 平均增加 15.7 个字母，参考雷尼单抗组的 BCVA 平均增加 14.6 个字母：Sun 公司的雷尼珠单抗生物仿制药在 nAMD 患者中的治疗效果等同于参考药物雷尼珠单抗。没有其他安全性或免疫原性问题：试验注册：CTRI/2020/09/027629，注册日期：2020年9月7日。

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

期刊介绍： Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. 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