在耐火性克朗氏病患者的皮下Infliximab:一个可能的biobetter?
Karin Cerna1,2, Dana Duricova1,3, Martin Lukas1,4,5
1Clinical and Research Center for Inflammatory Bowel Disease ISCARE and First Faculty of Medicine, Charles University, Prague, Czech Republic.
皮下注射的infliximab (IFX-SC) 在耐火克罗恩病患者中表现出持续的治疗持久性和改善的临床标志物. 与静脉注射因弗利西玛布相比,这种配方显示免疫性降低和血清水平稳定.
科学领域:
- 胃肠病学 胃肠病学
- 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:
- 皮下注射的infliximab (IFX-SC) 已被批准用于炎症性肠病.
- 与静脉注射因弗利西马布 (IFX-IV) 相比,有可能提高疗效.
研究的目的:
- 评估IFX-SC在耐火克罗恩病 (CD) 中的中期治疗持久性.
- 评估血清infliximab的最低水平 (TL IFX) 和抗IFX抗体 (ATI) 的动态.
- 分析CD活动的临床,血清和便标志物.
主要方法:
- 32名耐火性CD患者先前接受了≥2种生物药物治疗,接受了IFX-SC.
- 从基线 (W0) 到第30周 (W30) 的随访.
- 主要终点:治疗持久性在W30;次要:TL IFX,ATI,CD标志物.
主要成果:
- 在W30中,中期治疗持续率为53%.
- 中位数TL IFX迅速增加 (>15.5微克/毫升在W30),中位数ATI水平下降.
- 在继续治疗的患者中观察到C-反应蛋白,便calprotectin和哈维-布拉德肖指数的显著下降.
结论:
- 在耐火性CD患者中,IFX-SC显示出临床相关的改善.
- 与IFX-IV相比,IFX-SC表现出较低的免疫潜力和更稳定的TL IFX.
- 在最初为ATI阳性的患者中观察到高水平的ATI血清转化.
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