白介素-1阻断剂Rilonacept治疗心包炎,获得FDA授予孤儿药称号

2020-07-17 MedSci原创 MedSci原创

Rilonacept是每周一次的皮下注射重组融合蛋白,可阻断IL-1α和IL-1β信号传导。

Kiniksa Pharmaceuticals公司宣布ARCALYST(rilonacept)治疗心包炎,包括复发性心包炎,获得美国食品和药物管理局(FDA)授予孤儿药称号。Rilonacept是每周一次皮下注射的重组融合蛋白,可阻断白介素-1α(IL-1α)和白介素-1β(IL-1β)信号传导。

See the source image

图片来源:https://www.pharmacodia.com/yaodu/html/v1/biologics/9773d3352e206fef3df91b8757d63b67.html

Kiniksa最近报道了RHAPSODY的阳性数据,RHAPSODY是rilonacept在复发性心包炎患者中进行的3期临床试验。RHAPSODY达到了其预先设定的主要和所有次要疗效终点,表明rilonacept改善了复发性心包炎患者的预后。

但是使用rilonacept阻断IL-1可能会影响机体对感染免疫应答。据报道,服用rilonacept的患者存在严重的、威胁生命的感染。如果患者发生严重感染,应终止rilonacept。不建议将rilonacept与TNF抑制剂一起服用,因为可能会增加严重感染的风险。

关于复发性心包炎

复发性心包炎是一种自发性血管疾病,表现为胸痛,通常与电导率的变化有关,有时与心脏周围积水有关,称为心包积液。如果在4-6周的无症状期后又发作了一次,则被认为是复发性心包炎。目前尚无FDA批准的复发性心包炎治疗药物。

关于Rilonacept

Rilonacept是每周一次的皮下注射重组融合蛋白,可阻断IL-1α和IL-1β信号传导。 Rilonacept由Regeneron的开发,获得FDA批准用于治疗Cryopyrin蛋白相关的周期性综合症(CAPS)。Rilonacept治疗复发性心包炎,在2019年获得FDA授予突破性疗法指定。

原始出处:

https://www.firstwordpharma.com/node/1741063?tsid=4

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    2020-11-09 shanyongle
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    2021-02-23 xiaoyeshuang
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createdName=xiaoyeshuang, createdTime=Tue Feb 23 06:50:30 CST 2021, time=2021-02-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1710243, encodeId=78d21e102435d, content=<a href='/topic/show?id=7ac59e67604' target=_blank style='color:#2F92EE;'>#阻断#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97676, encryptionId=7ac59e67604, topicName=阻断)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b5ca31824852, createdName=41514497@qq.com, createdTime=Sun May 16 04:50:30 CST 2021, time=2021-05-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1651343, encodeId=a7a41651343b7, content=<a href='/topic/show?id=6eefe162275' target=_blank style='color:#2F92EE;'>#白介素-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71622, 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channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97680, encryptionId=08049e6803b, topicName=阻断剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=32a12500167, createdName=12498ca5m83暂无昵称, createdTime=Wed Jun 16 00:50:30 CST 2021, time=2021-06-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1715617, encodeId=16e81e1561752, content=<a href='/topic/show?id=37c0154e8c2' target=_blank style='color:#2F92EE;'>#Rilonacept#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15478, encryptionId=37c0154e8c2, topicName=Rilonacept)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=54e731968959, createdName=12498f6em17暂无昵称, createdTime=Sat Feb 27 12:50:30 CST 2021, time=2021-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=803536, 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372140, encodeId=c0b113e214043, content=<a href='/topic/show?id=6ca1e1621c4' target=_blank style='color:#2F92EE;'>#白介素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71621, encryptionId=6ca1e1621c4, topicName=白介素)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0e95336, createdName=budeshao, createdTime=Sun Jul 19 04:50:30 CST 2020, time=2020-07-19, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1656027, encodeId=91a3165602ee1, content=<a href='/topic/show?id=2a011829d7' target=_blank style='color:#2F92EE;'>#ACE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1829, encryptionId=2a011829d7, topicName=ACE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=635024767990, createdName=shanyongle, createdTime=Mon Nov 09 01:50:30 CST 2020, time=2020-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1778951, encodeId=7e321e78951a0, content=<a href='/topic/show?id=c33118392a' target=_blank style='color:#2F92EE;'>#ACEP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1839, encryptionId=c33118392a, topicName=ACEP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6eba113, 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channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97680, encryptionId=08049e6803b, topicName=阻断剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=32a12500167, createdName=12498ca5m83暂无昵称, createdTime=Wed Jun 16 00:50:30 CST 2021, time=2021-06-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1715617, encodeId=16e81e1561752, content=<a href='/topic/show?id=37c0154e8c2' target=_blank style='color:#2F92EE;'>#Rilonacept#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15478, encryptionId=37c0154e8c2, topicName=Rilonacept)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=54e731968959, createdName=12498f6em17暂无昵称, createdTime=Sat Feb 27 12:50:30 CST 2021, time=2021-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=803536, encodeId=20a2803536b7, content=这么厉害, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200720/956eb01f4b594ee783debae7a44d9096/e569cb8381764328b493c23491d86c27.jpg, createdBy=2cbc5401622, createdName=老婆子, createdTime=Mon Jul 20 20:19:30 CST 2020, time=2020-07-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1365247, encodeId=8e93136524e19, content=<a href='/topic/show?id=dfa045434e1' target=_blank style='color:#2F92EE;'>#孤儿药称号#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45434, encryptionId=dfa045434e1, topicName=孤儿药称号)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cd0d217, createdName=huiwelcome, createdTime=Sun Jul 19 04:50:30 CST 2020, time=2020-07-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372140, encodeId=c0b113e214043, content=<a href='/topic/show?id=6ca1e1621c4' target=_blank style='color:#2F92EE;'>#白介素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71621, encryptionId=6ca1e1621c4, topicName=白介素)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0e95336, createdName=budeshao, createdTime=Sun Jul 19 04:50:30 CST 2020, time=2020-07-19, status=1, ipAttribution=)]
    2020-12-13 xiaoyeshuang
  6. [GetPortalCommentsPageByObjectIdResponse(id=1656027, encodeId=91a3165602ee1, content=<a href='/topic/show?id=2a011829d7' target=_blank style='color:#2F92EE;'>#ACE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1829, encryptionId=2a011829d7, topicName=ACE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=635024767990, createdName=shanyongle, createdTime=Mon Nov 09 01:50:30 CST 2020, time=2020-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1778951, encodeId=7e321e78951a0, content=<a href='/topic/show?id=c33118392a' target=_blank style='color:#2F92EE;'>#ACEP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1839, encryptionId=c33118392a, topicName=ACEP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6eba113, 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  7. 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    2020-07-20 老婆子

    这么厉害

    0

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