拉尼比祖马布生物类似药与参考拉尼比祖马布用于新血管与年龄相关的黄斑变性:系统性审查和元分析
Nuno Rodrigues Alves1, Patrícia Barros Silva2, Catarina Barão2
1Department of Ophthalmology, Unidade Local de Saúde de São José, Lisbon, Portugal. nuno.al113@gmail.com.
概括
拉尼比祖马布生物仿制药对新血管与年龄相关的黄斑变性 (nAMD) 是安全有效的,为参考药物提供了具有成本效益的替代品. 研究显示了可比的疗效和安全性概况,支持它们在nAMD治疗中的使用.
科学领域:
- 眼科医生 眼科 眼科
- 药理学 药理学是指药理学的学科.
- 生物技术是生物技术.
背景情况:
- 神经血管与年龄相关的黄斑变性 (nAMD) 是视力丧失的主要原因.
- 抗血管内皮生长因子 (抗VEGF) 治疗,如拉尼比祖马布,是有效的,但昂贵.
- 生物类似药在nAMD治疗中提供了潜在的成本节约.
研究的目的:
- 在nAMD患者中,系统地审查和元分析拉尼比祖马布生物类似剂的疗效,安全性和免疫性,与参考拉尼比祖马布相比.
- 评估视觉敏度,视网膜厚度和新血管化变化.
- 为了评估安全结果和抗药抗体 (ADA) 发生率.
主要方法:
- 在PubMed,Embase,Cochrane图书馆和ClinicalTrials.gov.gov的系统文献搜索.
- 包括随机对照试验 (RCT),将拉尼比祖马布生物类似药与参考拉尼比祖马布进行比较.
- 结果的元分析,包括最佳校正视敏度 (BCVA),中央子场厚度 (CST),胆道新血管化 (CNV) 尺寸,安全性和ADA.
主要成果:
- 分析了10个涉及3704只眼睛的RCT.
- 短期BCVA显示了与生物类似药的统计学上显著但临床上可以忽略不计的改善.
- 长期随访显示了可比的BCVA,CST和安全结果;生物类似药显示了CNV大小的显著减少.
- 抗药抗体发生率在各组之间是相似的.
结论:
- 拉尼比祖马布生物仿制药的疗效,安全性和免疫性与针对nAMD的参考拉尼比祖马布具有可比性.
- 较小的短期视力敏度差异在临床上并不显著.
- 生物类药物代表了对nAMD的经济有效的治疗选择.
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