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ESID 2020:敏感性分析证实了Emapalumab治疗噬血细胞性淋巴组织细胞增多症(HLH)的功效

2020-10-19 Allan MedSci原创

结果显示,对标准疗法反应不足的HLH患者经Emapalumab治疗后的总缓解率(ORR)高达63%。

噬血细胞性淋巴组织细胞增多症(HLH)是一种罕见病,可在婴儿及年幼儿童中引起免疫功能障碍。尽管大多数患者不能明确原发病,但许多患者有原发性免疫性疾病。临床表现可能包括淋巴结肿大、肝脾肿大、发热及神经系统异常。

制药公司Sobi在欧洲免疫缺陷学会(ESID)第19次会议上公布了II/III期关键研究(NCT01818492)的敏感性分析结果,结果显示,对标准疗法反应不足的HLH患者经Emapalumab治疗后的总缓解率(ORR)高达63%。

尽管采用当今的标准护理:糖皮质激素和依托泊苷,无论是否使用环孢霉素,这些患者仍存在高度未满足的医疗需求。在过去的20年中,使用当前的标准疗法并未降低死亡率。

由于该疾病的罕见性,尚未建立衡量治疗反应率的标准方法。这项关键性研究使用临床客观缓解标准来确定原发性HLH对Emapalumab的敏感性。敏感性分析支持在原发性HLH研究中使用临床客观ORR作为主要终点。

 

原始出处:

https://www.firstwordpharma.com/node/1766146?tsid=4

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CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338226, encodeId=4610133822627, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2620, encryptionId=cd2a262068, topicName=APA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce072500140, createdName=12498b3em08(暂无昵称), createdTime=Wed Oct 21 01:29:30 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1388537, encodeId=44d9138853eac, content=<a href='/topic/show?id=7ef25e5346b' target=_blank style='color:#2F92EE;'>#敏感性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57534, encryptionId=7ef25e5346b, topicName=敏感性)], attachment=null, 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  5. [GetPortalCommentsPageByObjectIdResponse(id=1912461, encodeId=970319124618c, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Tue May 18 03:29:30 CST 2021, time=2021-05-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1805189, encodeId=4b4e180518961, content=<a href='/topic/show?id=3138e790655' target=_blank style='color:#2F92EE;'>#细胞性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77906, encryptionId=3138e790655, topicName=细胞性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=86b7385, createdName=lqrandywkz, createdTime=Tue Dec 22 12:29:30 CST 2020, time=2020-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1715517, encodeId=e8ab1e155171f, content=<a href='/topic/show?id=45476e0661' target=_blank style='color:#2F92EE;'>#Emapalumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6706, encryptionId=45476e0661, topicName=Emapalumab)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=97e831942757, createdName=ms3025846204744509, createdTime=Wed Oct 21 01:29:30 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1681880, encodeId=c886168188056, content=<a href='/topic/show?id=2fb489882cb' target=_blank style='color:#2F92EE;'>#血细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89882, encryptionId=2fb489882cb, topicName=血细胞)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a79127868468, createdName=ailian1211, createdTime=Thu Mar 04 20:29:30 CST 2021, time=2021-03-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1741243, encodeId=fc9b1e4124344, content=<a href='/topic/show?id=ed5340355da' target=_blank style='color:#2F92EE;'>#噬血细胞性淋巴组织细胞增多症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40355, encryptionId=ed5340355da, topicName=噬血细胞性淋巴组织细胞增多症)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=24f434894762, createdName=12498e8em83暂无昵称, createdTime=Fri Nov 13 10:29:30 CST 2020, time=2020-11-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1975626, encodeId=5fd519e5626f3, content=<a href='/topic/show?id=04ac8964c1' target=_blank 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CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338226, encodeId=4610133822627, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2620, encryptionId=cd2a262068, topicName=APA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce072500140, createdName=12498b3em08(暂无昵称), createdTime=Wed Oct 21 01:29:30 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1388537, encodeId=44d9138853eac, content=<a href='/topic/show?id=7ef25e5346b' target=_blank style='color:#2F92EE;'>#敏感性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57534, encryptionId=7ef25e5346b, topicName=敏感性)], attachment=null, 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  6. [GetPortalCommentsPageByObjectIdResponse(id=1912461, encodeId=970319124618c, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Tue May 18 03:29:30 CST 2021, time=2021-05-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1805189, encodeId=4b4e180518961, content=<a href='/topic/show?id=3138e790655' target=_blank style='color:#2F92EE;'>#细胞性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77906, encryptionId=3138e790655, topicName=细胞性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=86b7385, 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style='color:#2F92EE;'>#HLH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8964, encryptionId=04ac8964c1, topicName=HLH)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=循证小兵, createdTime=Tue Jun 01 05:29:30 CST 2021, time=2021-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317599, encodeId=1dce131e59964, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Wed Oct 21 01:29:30 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338226, encodeId=4610133822627, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2620, encryptionId=cd2a262068, topicName=APA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce072500140, createdName=12498b3em08(暂无昵称), createdTime=Wed Oct 21 01:29:30 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1388537, encodeId=44d9138853eac, content=<a href='/topic/show?id=7ef25e5346b' target=_blank style='color:#2F92EE;'>#敏感性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57534, encryptionId=7ef25e5346b, topicName=敏感性)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJnkE6UvGFfMS41qV0RicWvVTTeLMicqibeZH5GqO4YhNicyl1Y9jFhylIUBn9ntPYy9jhk5hrfic5cRYw/132, createdBy=5f822500020, createdName=ms5236388012055669, createdTime=Wed Oct 21 01:29:30 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588448, encodeId=036f15884483d, content=<a href='/topic/show?id=1cb8e014e0' target=_blank style='color:#2F92EE;'>#ESI#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7014, encryptionId=1cb8e014e0, topicName=ESI)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f4f817593223, createdName=skhzy, createdTime=Wed Oct 21 01:29:30 CST 2020, time=2020-10-21, status=1, ipAttribution=)]
    2021-06-01 循证小兵
  7. 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CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338226, encodeId=4610133822627, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2620, encryptionId=cd2a262068, topicName=APA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce072500140, createdName=12498b3em08(暂无昵称), createdTime=Wed Oct 21 01:29:30 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1388537, encodeId=44d9138853eac, content=<a href='/topic/show?id=7ef25e5346b' target=_blank style='color:#2F92EE;'>#敏感性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57534, encryptionId=7ef25e5346b, topicName=敏感性)], attachment=null, 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    2020-10-21 fengyi812
  8. 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  9. 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  10. 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    2020-10-21 skhzy

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