什么时候切换到皮下注射? RE-WATCH多中心研究
Lorenzo Bertani1, Davide Giuseppe Ribaldone2, Fabrizio Bossa3
1Department of Internal Medicine, Tuscany North-West ASL, Pontedera Hospital, Pontedera, Italy.
在六周早期切换到皮下注射因弗利西马布 (IFX) 时,对于维持临床和内镜缓解,其效果与晚期切换相同. 这种早期转换的生物类似药物 (CT- P13) 显示出可比的安全性和有效性结果.
科学领域:
- 胃肠病学和肝病学
- 药理学和治疗学
- 临床试验研究
背景情况:
- 提供静脉注射 (IV) 和皮下注射 (SC) 两种配方.
- 目前的指导方针允许在两次静脉注射后从静脉注射转换为SC CT- P13.
- 一些临床医生推迟SC切换,直到稳定临床缓解.
研究的目的:
- 将早期切换到SC CT- P13的疗效和安全性进行比较.
- 评估内镜反应,治疗持久性,临床缓解,内镜缓解和一年后的安全性.
- 评估切换时间对患者结果和治疗持续时间的影响.
主要方法:
- 一项前性研究比较了两个组:早期切换 (IV到SC CT-P13在6周) 和晚期切换 (在6个月).
- 一年内评估内镜反应,无类固醇临床缓解,内镜缓解和IFX保留率.
- 监测的临床指数,便中的calprotectin,C反应蛋白 (CRP) 和不良事件.
主要成果:
- 在早期和晚期切换组之间没有观察到内镜反应 (71. 4% vs 70. 8%),无类固醇临床缓解 (62. 5% vs 68. 7%) 或IFX保留率 (75. 0% vs 66. 7%) 在一年内.
- 早期切换组显示了更高内镜缓解率的趋势 (69.6%与52. 1%相比),尽管在统计学上并不显著.
- 不良事件在两组之间是可比的 (4. 5% vs 8. 3%),IV-IFX的复发率较低.
结论:
- 从IV-IFX到SC-IFX的早期切换在6周后是有效的,并且在一年后的临床和内镜缓解率与在6个月后的晚期切换相似.
- 这些发现支持早期过渡到皮下注射infliximab生物类似剂的疗效和安全性.
- 这种策略提供了与延迟切换相似的结果,有可能改善患者的便利性和治疗坚持.
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