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葛兰素史克宣布贝利尤单抗治疗狼疮性肾炎患者的III期临床试验取得整体阳性结果

2019-12-20 佚名 医谷

葛兰素史克(GSK)12月18日宣布,在针对活动性狼疮性肾炎(LN)患者规模最大的III期对照临床试验中,静脉注射用贝利尤单抗(商品名:倍力腾®) 取得了整体阳性结果。该疾病是由系统性红斑狼疮(SLE)累及肾脏引起的炎症,可能导致终末期肾病。

BLISS-LN试验达到主要终点以及所有关键性次要终点

有望于2020年上半年向美国药监当局递交申请

葛兰素史克(GSK)12月18日宣布,在针对活动性狼疮性肾炎(LN)患者规模最大的III期对照临床试验中,静脉注射用贝利尤单抗(商品名:倍力腾?) 取得了整体阳性结果。该疾病是由系统性红斑狼疮(SLE)累及肾脏引起的炎症,可能导致终末期肾病。

这项研究(BLISS-LN)旨在评估贝利尤单抗治疗活动性狼疮性肾炎患者的疗效与安全性,共入组448位患者。这项研究在2年治疗期内达到了主要肾脏疗效应答终点(PERR)。在所有患者中,接受贝利尤单抗与标准疗法的有效应答患者数量显着高于接受安慰剂与标准疗法的患者数量。(43% vs 32%,OR(95%置信区间):1.55(1.04,2.32)p = 0.0311)。

葛兰素史克首席科学官兼研发部总裁Hal Barron博士说:“狼疮性肾炎是系统性红斑狼疮最常见和最严重的并发症之一,影响多达60%的成人患者,目前患者的治疗选择有限。BLISS-LN试验的结果表明,贝利尤单抗将为这些患者的生活带来具有临床意义的显着改善。”

诺斯威尔健康中心费恩斯坦研究所风湿病科主任、教授、BLISS-LN试验首席研究员Richard Furie博士说:“我与贝利尤单抗的渊源始于约二十年前,当时我们在狼疮患者中进行了首次临床试验。如今,针对狼疮性肾炎患者的III期研究获得了成功,这是一项重要的成就。一直以来,常规疗法无法给狼疮肾炎患者带来足够的缓解,这个领域需要实现重大进步。”

与安慰剂相比,贝利尤单抗在所有四个关键性次要终点数据上均显示出统计学意义,包括治疗两年后的完全肾脏缓解(CRR)(最严格的肾脏缓解指标)、两年后的整体肾脏缓解(ORR)、一年后的PERR以及至死亡的时间或肾脏相关事件。在BLISS-LN试验中,接受贝利尤单抗治疗的患者的安全性结果与接受安慰剂加标准疗法的患者基本相当,安全性结果与贝利尤单抗的已知安全性特征保持一致。

目前在全球任何地方,贝利尤单抗尚未被推荐用于治疗重度活动性狼疮肾炎患者,这是因为既往并未针对这些患者进行评估。基于这些阳性的III期临床研究数据,葛兰素史克计划于2020年上半年递交申请,寻求对说明书进行更新。

完整的试验结果将在未来的科学会议上对外公布,并且发表于同行评审的医学期刊上。

关于狼疮性肾炎

系统性红斑狼疮(SLE)是狼疮最常见的形式,它是一种慢性、无法治愈的自身免疫性疾病,伴有一系列症状,可能会随时间而波动。这些症状包括关节疼痛或肿胀、极度疲劳、不明原因发热、皮疹和器官损伤。在狼疮性肾炎(LN)患者中,系统性红斑狼疮会累及肾脏引发炎症,并可能导致晚期肾脏疾病。尽管在过去几十年里,诊断与治疗领域都取得了进展,但狼疮性肾炎的预后仍然不佳。狼疮性肾炎的表现包括蛋白尿、血清肌酐水平升高以及尿沉渣的存在。

关于BLISS-LN

BLISS-LN试验入组448名成人患者,它是一项为期104周、随机、双盲、安慰剂对照III期临床试验,旨在评估静脉注射用贝利尤单抗(10mg/kg)与标准疗法(采用霉酚酸酯进行诱导缓解与维持治疗,或者采取环磷酰胺进行诱导缓解,然后使用硫唑嘌呤进行维持治疗,同时加用类固醇激素)治疗活动性狼疮性肾炎成人患者的疗效和安全性,对照组使用安慰剂加标准疗法。活动性狼疮性肾炎患者通过肾脏活检筛查进行确诊,需要符合2003年国际肾脏病学会/肾脏病理学会(ISN / RPS)的相关标准,需为临床活动性肾脏疾病。

主要终点PERR被定义为肾小球滤过率估计值(eGFR)≥60 mL/min/1.73m,或eGFR值相比上一次复发前下降不超过20%;尿蛋白:肌酐比值(uPCR)≤0.7;且没有出现治疗失败。最严格的次要终点CRR被定义为eGFR值与上一次复发前相比下降不超过10%,或者在正常范围内;uPCR<0.5;且没有出现治疗失败。ORR被定义为完全、部分或没有缓解。

关于贝利尤单抗(商品名:倍力腾?)

贝利尤单抗是一款针对B淋巴细胞刺激因子(BLys)的特异性抑制剂,是一种能够与可溶性BLyS结合的人源化单克隆抗体。贝利尤单抗不直接结合B细胞。通过结合BLyS,贝利尤单抗抑制B细胞(包括自身反应性B细胞)的生存,同时使得B细胞不容易分化成生产免疫球蛋白的浆细胞。

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beContent=null, objectType=article, channel=null, level=null, likeNumber=133, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88218, encryptionId=6f0188218ee, topicName=葛兰素史克)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d58a435, createdName=sjq027, createdTime=Sun Dec 22 08:22:00 CST 2019, time=2019-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1387381, encodeId=0a28138e381e3, content=<a href='/topic/show?id=8a3a6814425' target=_blank style='color:#2F92EE;'>#狼疮#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68144, encryptionId=8a3a6814425, topicName=狼疮)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7a6e2500005, createdName=sunrural_42825357, createdTime=Sun Dec 22 08:22:00 CST 2019, time=2019-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1516253, encodeId=bde5151625325, content=<a href='/topic/show?id=cd2892215bb' target=_blank style='color:#2F92EE;'>#贝利尤单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92215, encryptionId=cd2892215bb, topicName=贝利尤单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9a4f10942480, createdName=ms1692810954239974, createdTime=Sun Dec 22 08:22:00 CST 2019, time=2019-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524764, encodeId=09631524e641e, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Sun Dec 22 08:22:00 CST 2019, time=2019-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1532279, encodeId=7ddc15322e9ea, content=<a href='/topic/show?id=10b5825e4aa' target=_blank style='color:#2F92EE;'>#肾炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82574, encryptionId=10b5825e4aa, topicName=肾炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=84df12331144, createdName=villahu, createdTime=Sun Dec 22 08:22:00 CST 2019, time=2019-12-22, status=1, ipAttribution=)]
    2020-04-03 juliusluan78
  4. 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  5. 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  6. 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createdTime=Sun Dec 22 08:22:00 CST 2019, time=2019-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1532279, encodeId=7ddc15322e9ea, content=<a href='/topic/show?id=10b5825e4aa' target=_blank style='color:#2F92EE;'>#肾炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82574, encryptionId=10b5825e4aa, topicName=肾炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=84df12331144, createdName=villahu, createdTime=Sun Dec 22 08:22:00 CST 2019, time=2019-12-22, status=1, ipAttribution=)]
  7. 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  8. 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  9. 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  10. [GetPortalCommentsPageByObjectIdResponse(id=2088773, encodeId=7d772088e738a, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, createdName=839640778, createdTime=Wed Dec 25 12:22:00 CST 2019, time=2019-12-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1642057, encodeId=15aa164205ed8, content=<a href='/topic/show?id=679b9e514c8' target=_blank style='color:#2F92EE;'>#阳性结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97514, encryptionId=679b9e514c8, topicName=阳性结果)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=28fb22837833, createdName=12498cb5m20暂无昵称, createdTime=Thu Feb 06 16:22:00 CST 2020, time=2020-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916209, encodeId=1c3119162093f, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Fri Apr 03 21:22:00 CST 2020, time=2020-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1652968, encodeId=a4be1652968cc, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Thu Jul 16 00:22:00 CST 2020, time=2020-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1931487, encodeId=158e193148e84, content=<a href='/topic/show?id=a3d89601f2' target=_blank style='color:#2F92EE;'>#II期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9601, encryptionId=a3d89601f2, topicName=II期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, createdName=kksonne, createdTime=Wed Aug 26 02:22:00 CST 2020, time=2020-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1315774, encodeId=bb9e1315e7428, content=<a href='/topic/show?id=6f0188218ee' target=_blank style='color:#2F92EE;'>#葛兰素史克#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=133, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88218, encryptionId=6f0188218ee, topicName=葛兰素史克)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d58a435, createdName=sjq027, createdTime=Sun Dec 22 08:22:00 CST 2019, time=2019-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1387381, encodeId=0a28138e381e3, content=<a href='/topic/show?id=8a3a6814425' target=_blank style='color:#2F92EE;'>#狼疮#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68144, encryptionId=8a3a6814425, topicName=狼疮)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7a6e2500005, createdName=sunrural_42825357, createdTime=Sun Dec 22 08:22:00 CST 2019, time=2019-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1516253, encodeId=bde5151625325, content=<a href='/topic/show?id=cd2892215bb' target=_blank style='color:#2F92EE;'>#贝利尤单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92215, encryptionId=cd2892215bb, topicName=贝利尤单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9a4f10942480, createdName=ms1692810954239974, createdTime=Sun Dec 22 08:22:00 CST 2019, time=2019-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524764, encodeId=09631524e641e, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Sun Dec 22 08:22:00 CST 2019, time=2019-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1532279, encodeId=7ddc15322e9ea, content=<a href='/topic/show?id=10b5825e4aa' target=_blank style='color:#2F92EE;'>#肾炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82574, encryptionId=10b5825e4aa, topicName=肾炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=84df12331144, createdName=villahu, createdTime=Sun Dec 22 08:22:00 CST 2019, time=2019-12-22, status=1, ipAttribution=)]
    2019-12-22 villahu
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