从静脉注射到皮下注射的Infliximab:相同但不同? 来自第三级中心的现实世界证据
María José Temido1, Andrea Silva1, Sandra Lópes1
1Gastroenterology Department, Centro Hospitalar e Universitário de Coimbra. Coimbra, Portugal Gastroenterology Department Centro Hospitalar e Universitário de Coimbra Coimbra Portugal.
在克罗恩病和性结肠炎患者中,切换为皮下注射因弗利克西马布维持了临床缓解. 这种新配方显示Infliximab血水平增加和耐受性良好,没有检测到抗药抗体.
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:
- 已经批准了一种皮下注射的Infliximab配方,这可能比静脉注射更方便.
- 与静脉注射对应物相比,皮下注射因弗利克西马布的药理动力学和免疫性数据有限.
研究的目的:
- 为了比较皮下注射因弗利克西马布和静脉注射因弗利克西马布的疗效和耐受性.
- 评估皮下配方是否会导致更高的INFLIXIMAB血水平.
主要方法:
- 一个回顾性,单中心的队列研究,涉及41名克罗恩病或性结肠炎患者.
- 静脉注射因弗利克西马布稳定的患者被转换为皮下注射因弗利克西马布 (120毫克每2周).
- 临床评估,血因弗利克西马布水平和抗药抗体在基线和第2,8周和第16周被测量.
主要成果:
- 所有41名患者都保持了临床缓解,治疗持续率为95.1%.
- 从第0周到第16周,INFLIXIMAB血水平的中位数显著增加 (4.89至21.55ug/mL).
- 没有检测到抗药抗体;轻度不良事件包括注射部位反应和关节痛.
结论:
- 切换到皮下注射的infliximab有效地维持了IBD患者的临床反应.
- 皮下配方导致INFLIXIMAB的血水平增加,并且表现出良好的耐受性.
- 皮下注射Infliximab可能会降低同时服用免疫调节剂的需要.
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