目的:本系统综述和荟萃分析提供了雷珠单抗生物仿制药相对于参考雷珠单抗抗血管内皮生长因子(VEGF)疗法治疗新生血管性年龄相关性黄斑变性(nAMD)的有效性和安全性。
方法:我们从2003年1月到2022年8月在OvidMEDLINE上进行了系统搜索,EMBASE和Cochrane控制的试验登记册。我们纳入了报告糖尿病视网膜病变早期治疗变化的研究,测量最佳矫正视力(BCVA),从基线BCVA丢失或增加超过15个字母的患者人数,治疗组之间视网膜厚度和不良事件的变化。以下研究被排除:生物仿制药和参考雷珠单抗玻璃体内注射后未报告视觉结果的研究,研究组结合抗VEGF药物与激光或类固醇注射,假注射作为对照比较,没有英文全文和非比较的研究,观察性研究设计。
结果:本系统评价和荟萃分析纳入了4项随机对照试验(RCT)和1544只眼基线的5项研究。我们的系统评价中的研究发现,在视觉和解剖学结果方面,参考雷珠单抗和雷珠单抗生物仿制药(FYB201,SB11,RanizuRel和Lupin'sranibizumab)之间没有显着差异。生物仿制药和参考雷珠单抗在治疗紧急不良事件方面没有检测到显著差异(风险比,RR1.06,95%CI(0.91至1.23),p=0.45,I2=52%)或具有显著异质性的IOP相关不良事件(RR2.59,95%CI(0.11至62.25),p=0.56,I2=76%)。
结论:这项对四个随机对照试验的系统评价显示视觉结果无显著差异,视网膜厚度结果,以及用于nAMD治疗的生物仿制药和参考雷珠单抗治疗之间的不良事件的荟萃分析。
OBJECTIVE: This systematic
review and meta-analysis provides a summary of the efficacy and safety of ranibizumab biosimilars relative to reference ranibizumab anti-vascular endothelial growth factor (VEGF) therapy for the treatment of neovascular age-related macular degeneration (nAMD).
METHODS: We conducted systematic searches from January 2003 to August 2022 on Ovid MEDLINE, EMBASE and the Cochrane Controlled Register of Trials. We included studies reporting changes in early treatment diabetic retinopathy study-measured best-corrected visual acuity (BCVA), number of patients who lost or gained more than 15 letters in BCVA from baseline, changes in retinal thickness and adverse events between treatment arms. The following studies were excluded: studies that did not report visual outcomes following biosimilar and reference ranibizumab intravitreal injections, study arms combining anti-VEGF agents with laser or steroid injections, sham injections as a control comparator, studies without English full texts and non-comparative, observational study design.
RESULTS: Five studies reported on four randomised controlled trials (RCTs) and 1544 eyes at baseline were included in this systematic
review and meta-analysis. The studies in our systematic
review found no significant differences between reference ranibizumab and ranibizumab biosimilar medications (FYB201, SB11, RanizuRel and Lupin\'s ranibizumab) for visual and anatomical outcomes. No significant differences were detected between biosimilar and reference ranibizumab for treatment emergent adverse events (risk ratio, RR 1.06, 95% CI (0.91 to 1.23), p=0.45, I2=52%) or IOP-related adverse events with significant heterogeneity (RR 2.59, 95% CI (0.11 to 62.25), p=0.56, I2=76%).
CONCLUSIONS: This systematic
review of four RCTs demonstrated no significant difference in visual outcomes, retinal thickness outcomes, as well as meta-analysis of adverse events between biosimilar and reference ranibizumab therapies for nAMD treatment.