炎症性肠道疾病患者的皮下因弗利克西马布截止点:来自ENEIDA注册表的数据
Marisa Iborra1, Berta Caballol2, Alejandro Garrido1
1Gastroenterology Department, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
切换到皮下注射的因弗利克西马布 (SC-IFX) 可以安全地维持克罗恩病的缓解.
科学领域:
- 胃肠道学和免疫学
- 药理动力学和药物监测
背景情况:
- 静脉注射infliximab (IV-IFX) 是治疗诸如克罗恩病 (CD) 和性结肠炎 (UC) 等炎症性肠道疾病的标准疗法.
- 转换为皮下注射因弗利西马布 (SC-IFX) 仿生药提供了一个可能更方便的注射途径.
- 以前的研究表明,从IV-IFX切换后,SC-IFX保持了临床缓解和药物水平.
研究的目的:
- 为了评估从IV-IFX转换为SC-IFX的长期结果,在CD和UC的患者中.
- 确定药物度值,以维持转换后的缓解.
- 在过渡到SC-IFX后,确定响应丧失的预测因素.
主要方法:
- 多中心观测研究.
- 在切换前至少24周内将CD和UC患者纳入临床缓解期.
- 切换后监测临床参数,药物水平和安全概况.
主要成果:
- 包括220名患者 (74名UC,146名CD).
- 切换后SC-IFX水平显著增加,而临床缓解和炎症标志物保持稳定.
- 对缓解的最佳SC-IFX最低度值被确定为12.2微克/毫升在第12周和13.2微克/毫升在第52周.
结论:
- 从IV-IFX切换到SC-IFX是长期维持CD和UC缓解的安全有效策略.
- SC-IFX最低度为12-13微克/毫升,与持续的临床和生化缓解有关.
- 药物持久性很高 (92%在第52周),具有良好的安全性.
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