Ratra Dhanashree, Roy Krishnakanta, Giridhar Sneha, Madaan Sushant
Department of Vitreoretinal Diseases, Medical Research Foundation, Sankara Nethralaya, 41/18, College Road, Chennai, 600006, India.
Ophthalmol Ther. 2022 Feb;11(1):135-149. doi: 10.1007/s40123-021-00416-4. Epub 2021 Nov 5.
To analyze the efficacy of biosimilar ranibizumab compared to innovator ranibizumab and bevacizumab.
We retrospectively analyzed consecutive patients treated with biosimilar ranibizumab for wet age-related macular degeneration (AMD) and macular edema (ME) (due to diabetes and vein occlusion) and compared them with ranibizumab- and bevacizumab-treated patients.
Of 202 patients, 67 (33.2%) received biosimilar ranibizumab (BSR), 69 (34.2%) ranibizumab (RBZ) and 66 (32.7%) bevacizumab (BEV). All patients received three consecutive injections followed by pro re nata dosing. The follow-up ranged from 3 to 24 months. The mean numbers of injections were 6.68 for RBZ, 6.4 for BEV and 4.7 for BSR. At 3 months, nAMD (n = 115, 56.9%) and ME (n = 87, 43.1%) groups showed significant improvement in vision and central foveal thickness (CFT) across all three agents. After ≥ 6 months, the effects were maintained in the AMD group but not in the ME group. Maximum effect was seen at 1 month. At no point in time was a significant difference noted among the three anti-vascular endothelial growth factor (anti-VEGF) agents. No major safety concerns were noted.
Biosimilar ranibizumab is comparable to innovator ranibizumab and bevacizumab in efficacy and safety.
分析生物类似药雷珠单抗与原研雷珠单抗和贝伐单抗相比的疗效。
我们回顾性分析了连续接受生物类似药雷珠单抗治疗湿性年龄相关性黄斑变性（AMD）和黄斑水肿（ME）（由糖尿病和静脉阻塞引起）的患者，并将他们与接受雷珠单抗和贝伐单抗治疗的患者进行比较。
202例患者中，67例（33.2%）接受生物类似药雷珠单抗（BSR），69例（34.2%）接受雷珠单抗（RBZ），66例（32.7%）接受贝伐单抗（BEV）。所有患者均连续接受三次注射，随后按需给药。随访时间为3至24个月。RBZ的平均注射次数为6.68次，BEV为6.4次，BSR为4.7次。在3个月时，新生血管性AMD组（n = 115，56.9%）和ME组（n = 87，43.1%）在使用所有三种药物后视力和中心凹厚度（CFT）均有显著改善。≥6个月后，AMD组的效果得以维持，但ME组未维持。最大效果出现在1个月时。在任何时间点，三种抗血管内皮生长因子（抗VEGF）药物之间均未观察到显著差异。未发现重大安全问题。
生物类似药雷珠单抗在疗效和安全性方面与原研雷珠单抗和贝伐单抗相当。
