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Gastroenterology:Upadacitinib治疗中重度克罗恩病II期临床获得成功

2020-06-29 MedSci原创 MedSci原创

Upadacitinib治疗可提高克中重度克罗恩病患者内镜缓解率

近日研究人员评估了口服选择性Janus激酶1抑制剂Upadacitinib对克罗恩病(CD)的疗效和安全性。
 
本次研究为双盲,2期试验,成人中重度CD患者参与,患者对免疫抑制剂或肿瘤坏死因子拮抗剂反应不足或不耐受,随机接受安慰剂,每天两次服用3 mg、6 mg、12 mg或24 mg Upadacitinib或Upadacitinib 24 mg,每天一次,并在第12周或16周进行回肠结肠镜检查评估。完成第16周治疗的患者继续进行Upadacitinib维持治疗至36周。研究的主要终点为16周的临床缓解和12周或16周的内镜缓解。
 
220名患者参与研究,3 mg、6 mg、12 mg、24 mg(每日2次)以及24 mg(每日1次) Upadacitinib 组分别有13%、27%、 11%、22%以及14%的患者达到临床缓解,而安慰剂临床缓解率为11%。上述各种内镜缓解率分别为10%、8%、8%、22%和14%,安慰剂组无内镜缓解。在诱导期内,随着剂量的增加,内镜缓解率增加,但临床缓解率无显著影响,各组的缓解率可持续到第52周。在诱导期,与安慰剂组相比,Upadacitinib组患者感染和严重感染的发生率更高。每日两次12mg和24mg Upadacitinib组患者的总胆固醇、高密度脂蛋白和低密度脂蛋白胆固醇水平显著升高。
 
临床研究显示,Upadacitinib治疗可提高克中重度克罗恩病患者内镜缓解率。
 
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    2020-11-25 许安
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    2020-07-01 般若傻瓜
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