Long-term efficacy and safety of RazumabTM (biosimilar ranibizumab) in Indian patients with retinal diseases: results from retrospective REAR RD-2 study

Shashikant Sharma, A. Chaturvedi, N. Dave, Ankita Shah
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Abstract

Background: To evaluate risk factors associated with retinal diseases and efficacy and safety of RazumabTM (biosimilar ranibizumab) in the management of retinal diseases in Indian patients with wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV).Methods: In the retrospective, observational REAR RD-2 study, all patients with retinal diseases who were treated with biosimilar ranibizumab were included from multiple Indian sites. The demographic parameters, disease characteristics and treatment details were recorded. Efficacy assessments included improvement in best corrected visual acuity (BCVA), and decrease in central subfield thickness (CSFT), intra-retinal fluid (IRF) and sub-retinal fluid (SRF) from baseline to week 48.Results: Data of 1422 patients (wet AMD-27.57%; DME-30.7%, RVO-33.47%; mCNV-5.48%), who were treated with biosimilar ranibizumab, was analyzed. The most common age group of patients was 61-70 years (36.6%). The most common ocular risk factor identified was glaucoma (24.90%). A total of 85.72% patients were treatment naïve and 14.28% were previously treated patients. Biosimilar ranibizumab treatment resulted in significant (p<0.05) improvements in the mean BCVA and CSFT, and the proportion of patients with IRF and SRF was significantly reduced throughout the treatment. No new safety concerns with biosimilar ranibizumab were observed.Conclusions: Retinal diseases are more common in the age group of 61-70 years. Glaucoma was the most common ocular risk factor identified for retinal diseases. Long-term treatment with biosimilar ranibizumab was effective and well-tolerated in retinal diseases including wAMD, DME, RVO and mCNV in real-world Indian scenario.  
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RazumabTM(雷尼单抗生物仿制药)在印度视网膜疾病患者中的长期疗效和安全性:来自REAR RD-2的回顾性研究结果
背景:评估与视网膜疾病相关的危险因素,以及RazumabTM(生物仿制药雷尼单抗)治疗印度湿性年龄相关性黄斑变性(wet AMD)、糖尿病性黄斑水肿(DME)、视网膜静脉闭塞(RVO)和近视脉络膜新生血管(mCNV)患者视网膜疾病的疗效和安全性。方法:在回顾性观察性REAR RD-2研究中,来自印度多个地点的所有接受雷尼单抗生物仿制药治疗的视网膜疾病患者。记录人口统计学参数、疾病特征和治疗细节。疗效评估包括从基线到第48周最佳矫正视力(BCVA)的改善,中央亚野厚度(CSFT)、视网膜内液(IRF)和视网膜下液(SRF)的减少。结果:1422例患者的数据(湿AMD-27.57%;rvo测距装置- 30.7%——33.47%;mCNV-5.48%),接受雷尼单抗生物仿制药治疗的患者进行分析。最常见的年龄组为61 ~ 70岁(36.6%)。最常见的眼部危险因素是青光眼(24.90%)。85.72%的患者接受治疗naïve, 14.28%为既往治疗患者。雷尼单抗生物仿制药治疗显著(p<0.05)改善了平均BCVA和CSFT,整个治疗过程中发生IRF和SRF的患者比例显著降低。未观察到雷尼单抗生物仿制药的新的安全性问题。结论:视网膜病变多见于61 ~ 70岁年龄组。青光眼是视网膜疾病最常见的眼部危险因素。在真实的印度场景中,长期使用生物仿制药雷尼单抗治疗视网膜疾病(包括wAMD、DME、RVO和mCNV)是有效且耐受性良好的。
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