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中重度斑块型银屑病治疗药物依奇珠单抗临床III期研究(RHBH)中国人群取得积极主要研究结果

2021-04-27 礼来 礼来

拓咨®(依奇珠单抗)在中国患者中耐受性良好,未发现新的安全性信号。

2021年4月23日,礼来中国宣布,评估依奇珠单抗用于中国成人中重度银屑病患者的III期临床研究(RHBH)顺利完成,主要研究数据于今日在美国AAD大会中成功发表,研究达到了两个共同主要终点和所有关键次要终点。

RHBH研究是一项在中国开展的,多中心、随机、双盲、安慰剂对照III期临床研究。本项研究的共同主要终点是评估依奇珠单抗 80mg每2周(Q2W)或依奇珠单抗 80mg每4周(Q4W)给药治疗中至重度斑块型银屑病患者在第12周达到静态医师总体评估(sPGA)(0,1)且较基线至少改善2分的患者比例以及达到PASI 75的患者比例。此外,12周后随机分配维持给药期至第60周以评估长期安全性及有效性。

在第12周时,依奇珠单抗80 mg Q2W组有86.4%的患者达到sPGA(0,1),同时93.8%的患者达到了PASI 75,82.4%的患者达到了PASI 90,而PASI 100的应答率也达到了33%。此外,维持给药组患者高应答率持续维持至60周。

RHBH研究的全国主要研究者、上海交通大学附属瑞金医院皮肤科郑捷教授表示:“随着白介类生物制剂的上市,广大银屑病患者有望实现PASI 90甚至PASI 100的治疗目标,患者的生活质量改善也取得了质的飞跃。此次依奇珠单抗在中国银屑病患者中的临床试验结果发布,再次确认了依奇珠单抗的疗效和安全性,为临床提供了更多的证据。”

 

上海交通大学附属瑞金医院皮肤科 郑捷教授

在起效时间方面,在第1周,依奇珠单抗80 mg Q2W组的PASI 50应答率便显着高于安慰剂组;而在第2周,依奇珠单抗80 mg Q2W组的PASI 75和sPGA(0,1)的应答率便显着高于安慰剂组。

同时,RHBH研究的安全性数据显示, 依奇珠单抗在中国患者中耐受性良好,未发现新的安全性信号。

依奇珠单抗于2018年被纳入第一批临床急需境外新药名单,并于2019年08月29日获得国家药品监督管理局批准,用于治疗成人中至重度斑块型银屑病。本次III期临床结果的发布验证了依奇珠单抗在中国中重度斑块型银屑病患者中的有效性及安全性。

礼来中国高级副总裁、药物发展与医学事务中心负责人王莉博士表示:“在中国,约有650万患者长期饱受银屑病困扰,传统治疗存在诸多未满足的临床需求。礼来中国自身免疫领域的研发布局和策略与中国患者的需求密切相关,依奇珠单抗是礼来中国加速将创新药品带入中国的重要成果之一,在通过第一批临床急需境外新药提前获批上市后,礼来继续完成了在中国中重度银屑病患者中的Ⅲ期临床研究,本次RHBH研究取得的积极结果也将为依奇珠单抗惠及更多的中国银屑病患者打下坚实基础。”

 

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    2021-12-13 juliusluan78
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  5. 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  6. 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  7. 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  8. 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createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Tue Apr 27 18:10:20 CST 2021, time=2021-04-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=960937, encodeId=03df96093ee0, content=好消息, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210127/50a003c4097845e182c08afd64d8a509/bd766dfebe9c40e0bca2dae964601bdc.jpg, createdBy=22de5454917, createdName=carrotlyl, createdTime=Tue Apr 27 14:23:25 CST 2021, time=2021-04-27, status=1, ipAttribution=)]
    2021-04-28 医鸣惊人

    认真学习了

    0

  9. 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    2021-04-27 jyzxjiangqin

    好文章!

    0

  10. 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createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Tue Apr 27 18:10:20 CST 2021, time=2021-04-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=960937, encodeId=03df96093ee0, content=好消息, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210127/50a003c4097845e182c08afd64d8a509/bd766dfebe9c40e0bca2dae964601bdc.jpg, createdBy=22de5454917, createdName=carrotlyl, createdTime=Tue Apr 27 14:23:25 CST 2021, time=2021-04-27, status=1, ipAttribution=)]
    2021-04-27 carrotlyl

    好消息

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