礼来和Incyte宣布其口服JAK抑制剂Baricitinib在中度至重度特应性皮炎患者中进行的3期临床研究BREEZE-AD5的阳性结果

2020-02-01 不详 MedSci原创

礼来和Incyte宣布,其口服选择性JAK抑制剂baricitinib达到了BREEZE-AD5的主要研究终点。该研究为3期临床、随机安慰剂对照,用于评估Baricitinib治疗成人中重度特应性皮炎(AD)患者安全性和有效性的研究。主要终点指标定义为第16周时,湿疹面积和严重程度指数(EASI)与基线相比至少达到75%或更高比例。

礼来和Incyte宣布,其口服选择性JAK抑制剂baricitinib达到了BREEZE-AD5的主要研究终点。该研究为3期临床、随机安慰剂对照,用于评估Baricitinib治疗成人中重度特应性皮炎(AD)患者安全性和有效性的研究。主要终点指标定义为第16周时,湿疹面积和严重程度指数(EASI)与基线相比至少达到75%或更高比例。

礼来公司免疫学发展副总裁Lotus Mallbris博士说:"今天的结果,加上先前报道的3期临床试验的阳性结果,进一步巩固了我们致力于在美国针对患有慢性且经常复发的皮肤病(AD)患者进行口服JAK抑制剂治疗的决心。"

BREEZE-AD5是一项在北美进行的多中心,双盲,随机,安慰剂对照研究,评估了1 mg和2 mg剂量的Baricitinib单药治疗成人中重度特应性皮炎的疗效和安全性。在这项研究中,2 mg剂量的Baricitinib达到了主要终点,这是由在第16周达到EASI75受试者的比例确定的,并减少了瘙痒的严重程度。

BREEZE-AD5中的安全性与已知的Baricitinib在AD中的安全性结果一致。最常见的治疗紧急事件(TEAE)包括上呼吸道感染、鼻咽炎和腹泻。试验未报告静脉血栓栓塞事件(VTE)或死亡。

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topicName=JAK抑制剂Baricitinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=320b7680428, createdName=ms2694732865965676, createdTime=Mon Feb 03 09:01:00 CST 2020, time=2020-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1515418, encodeId=5560151541808, content=<a href='/topic/show?id=b5e022149cc' target=_blank style='color:#2F92EE;'>#中度至重度特应性皮炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22149, encryptionId=b5e022149cc, topicName=中度至重度特应性皮炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6ad510789639, createdName=ms6980045490879608, createdTime=Mon Feb 03 09:01:00 CST 2020, time=2020-02-03, status=1, ipAttribution=)]
    2020-11-04 jklm09
  5. 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  7. 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  8. 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topicName=JAK抑制剂Baricitinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=320b7680428, createdName=ms2694732865965676, createdTime=Mon Feb 03 09:01:00 CST 2020, time=2020-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1515418, encodeId=5560151541808, content=<a href='/topic/show?id=b5e022149cc' target=_blank style='color:#2F92EE;'>#中度至重度特应性皮炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22149, encryptionId=b5e022149cc, topicName=中度至重度特应性皮炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6ad510789639, createdName=ms6980045490879608, createdTime=Mon Feb 03 09:01:00 CST 2020, time=2020-02-03, status=1, ipAttribution=)]
    2020-02-03 zhouqu_8
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