在炎症性肠病中,阿达利穆马布的持久性及其生物类似物:现实世界的研究
María Carmen Fernández-Cano1,2, Antonio Jesús Fernández-Cano3, María Mar Martín-Rodríguez1
1Gastroenterology and Hepatology Unit, Virgen de las Nieves University Hospital, 18014 Granada, Spain.
Journal of clinical medicine
|January 23, 2024
概括
阿达利穆马布生物仿制药的疗效和安全性与参考产品相比相当. 生物类似药的持续性更高,尽管切换组经历了更严重的事件,支持生物类似药在IBD管理中的使用.
科学领域:
- 胃肠病学和肝病学
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 阿达利穆马布生物仿制药是炎症性肠病 (IBD) 的新兴治疗选择.
- 了解生物类似物持久性和可互换性对于临床实践和医疗保健可持续性至关重要.
研究的目的:
- 为了比较在IBD患者中阿达利穆马布生物类似药与参考产品的持续性.
- 为了评估不同阿达利穆马布配方的安全性,疗效和生物标志物概况.
主要方法:
- 这是一项追溯性观察性研究,涉及104名IBD患者.
- 三组:阿达利穆马布生物类似药,参考阿达利穆马布,以及从参考转换为生物类似药的患者.
- 主要结局:通过Kaplan-Meier分析对12个月的持续性进行评估. 二次结果:安全性,疗效和生物标志物.
主要成果:
- 在12个月内,生物类似物持续性高于参考产品.
- 轻度不良事件或临床反应率 (43%在第20周) 没有显著差异.
- 转换为生物类似药的组体验了更高频率的严重不良事件.
结论:
- 阿达利穆马布生物仿制药是IBD管理的临床同等和具有成本效益的替代品.
- 虽然通常是安全和有效的,但需要仔细考虑可互换性,特别是在患者切换配方时.
- 对生物仿制药使用的信心增加可以提高医疗保健系统的可持续性.
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