生物类似切换在IBD:安全性,疗效和免疫性在10,812名患者 - 一个系统的审查和元分析
Dian-Yu Zheng1, Li-Ying Zhou1, Yu-Hong Huang1
1Gastroenterology, First Hospital of China Medical University, china.
Revista espanola de enfermedades digestivas
|November 17, 2025
概括
在从原始药物转换后,对炎症性肠病 (IBD) 患者来说,因弗利西马布和阿达利穆马布的生物相似药物是有效和安全的. 这一元分析证实了可比的临床缓解,稳定的生物标志物和类似的安全概况,支持它们的使用.
科学领域:
- 胃肠病学和肝病学 胃肠学和肝病学
- 药理学和制药科学 药理学和制药科学
- 免疫学 免疫学 免疫学
背景情况:
- 在炎症性肠病 (IBD) 中,因弗利西马布和阿达利穆马布生物类似药的日益普及,为节省成本提供了机会.
- 在从原始生物制剂转换为生物类似药后,对长期疗效,免疫性和安全性的担忧仍然存在.
- 这一元分析旨在综合现有证据,分析患者在过渡到生物类似药后的结果.
研究的目的:
- 在IBD患者中,评估从原始药物infliximab和adalimumab转换为其生物类似药的疗效和安全性.
- 评估免疫性,包括抗药抗体 (ADA) 发生率,过渡后.
- 综合临床缓解,停药率和生物标志物稳定性 (C反应蛋白,便calprotectin) 的数据.
主要方法:
- 在PubMed,Embase和MEDLINE的系统文献搜索 (开始至2025年6月) 进行RCT和观察性研究.
- 包括比较生物类似药物 (如CT-P13,SB2,SB5) 与IBD患者发病原体的研究.
- 主要结局:临床缓解,停药,不良事件,CRP,便calprotectin和ADA发生率. 计算了偏差风险和聚合效应估计 (ORs).
主要成果:
- 对37项研究 (10812名患者) 的分析显示,在克罗恩病 (CD) 和性结肠炎 (UC) 中,生物类似药与原始药的临床缓解率相似.
- 转换后生物标志物 (CRP,便calprotectin) 保持稳定,综合停药率为13%.
- 安全性概况相似,ADA发病率没有显著差异 (OR = 0.96). 由于随访持续时间和研究设计,注意到异质性.
结论:
- 生物仿制药在IBD患者中显示出与原始生物药物相比的可比性,安全性和免疫性.
- 这些发现支持在单个和多个切换场景中使用生物类似药.
- 建议对结果进行标准化报告,包括粘膜愈合和药物监测,以实现最佳的现实世界采用.
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