在皮肤下注射Infliximab治疗克罗恩病:来自GETAID的BioLap- Rem多中心研究
M André1, J Kirchgesner2, D Laharie3
1Department of Gastroenterology, University Hospital of Besançon, France.
在从静脉注射疗法转换的患者中,皮下注射的infliximab (SC IFX) 有效治疗活跃的围克罗恩病 (pCD) 并维持缓解. 这项研究证实SC IFX是PCD治疗的安全和可行的选择.
科学领域:
- 胃肠病学
- 免疫学
- 药理学
背景情况:
- 静脉注射因弗利西马布 (IFX) 是对周围门克罗恩病 (pCD) 的标准治疗方法.
- 关于新型皮下注射IFX治疗pCD的疗效和安全性的数据有限.
研究的目的:
- 评估 SC IFX 的有效性和安全性.
- 在转换为SC IFX后,评估活跃PCD的临床缓解率和非活跃PCD的复发率.
主要方法:
- 一个多中心的回顾性队列研究,涉及183名pCD患者.
- 患者被分为两个组:在SC IFX开始时的活跃PCD (组1) 和转换前的不活跃PCD (组2).
- 主要终点是6个月后临床缓解 (组1) 和pCD复发 (组2).
主要成果:
- 在第1组中,44. 6%的患者在6个月后获得了临床缓解,87. 7%的患者在6个月后获得了临床缓解,35. 5%的患者在6个月后获得了缓解,包括去除塞顿.
- 高BMI是活性pCD中缓解的唯一独立预测因素.
- 在第二组中,没有复发的存活率为6个月94. 3%和12个月87. 9%.
- 有83%的患者经历了与注射相关的不良事件.
结论:
- 在治疗活跃的PCD方面,皮下注射Infliximab的有效性和安全性得到了证明.
- 在从静脉治疗转换的患者中,SC IFX也有效维持缓解.
- 这些发现支持在常规临床实践中使用SC IFX治疗周克罗恩病.
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