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NEJM:新药物Baricitinib治疗难治性类风湿性关节炎大获成功

2016-04-01 崔倩 译 MedSci原创

在一项临床三期研究中,维也纳医科大学和斯坦福大学的一项国际研究合作取得了重大成果,即药物Baricitinib对于类风湿关节炎的治疗。原始出处:Mark C. Genovese, Joel Kremer, Omid Zamani,et al.Baricitinib in Patients with Refractory Rheumatoid Arthritis,NEJM,2016.3.31

在一项临床三期研究中,维也纳医科大学和斯坦福大学的一项国际研究合作取得了重大成果,即药物Baricitinib对于类风湿关节炎的治疗研究发现:该试验人群的疾病症状明显减少。该结果发表在NEJM杂志上。

Baricitinib的全球第一项临床三期研究介绍了其治疗类风湿关节炎的显著效果。Baricitinib是Janus激酶1和2的口服抑制剂。该激酶是一种胞内酶,当细胞外信使分子,例如干扰素或白细胞介素6,对接到细胞中,该激酶就会被激活,从而引发炎症应答事件。

这项研究是由美国礼来公司赞助,由维也纳医科大学和斯坦福大学(美国)领导了这项研究,周期为24周,共包括527人。该研究的测试者曾接受许多常规治疗疗法,包括一种甚至几种生物制剂,但都没有成功治疗。参与者被分为三组,一组为每天2mg baricitinib组,一组为每天4mg,另外一组为安慰剂对照组。

结果表明,接受baricitinib的受试者表现出的症状显著改善。他们有较少的痛苦和关节肿胀,疾病活动的综合检测表明也得到了广泛的改善。相比于安慰剂组,4毫克剂量组比2毫克剂量组有更好的效果。不良事件发生率与已知的生物疗法相当。

“有了Baricitinib,即使目前使用的药物不够有效,我们也有了一种药物可以对该类患者起作用,”该研究的作者,维也纳医科大学临床医学内科医学主任Joseph Smolen解释说。“尽管很长病程和疾病的难治性,并且缺乏建立一系列成功的治疗方法,但仍有约10%的患者的症状得到了很好的缓解,即在六个月内药物治愈样状态,几乎一半的患者表现出在疾病的活动性和身体功能的显著改善。这一切都可以在不久的将来风湿性关节炎的治疗中,成为一个可用的新基础。”

该药物还有另一个优点,Smolen解释到:“该药物是口服,每日一次,不像其他药物,不必须使静脉注射或皮下注射。这对于受影响的人会更加舒适。”

风湿性关节炎是一种主要发生于女性的一种慢性自身免疫性缺陷疾病(大约三分之二的人会受影响),最经常发生在40至70岁之间的年龄。它会导致关节发炎。该疾病表现为为肿胀,发热和功能受限。如果不进行治疗,它会导致增加关节的破坏和关节附近的骨,从而导致非正常定位骨,变形和增加永久性残疾。

原始出处:

Mark C. Genovese, Joel Kremer, Omid Zamani,et al.Baricitinib in Patients with Refractory Rheumatoid Arthritis,NEJM,2016.3.31

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    2016-04-03 lmm397
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  5. [GetPortalCommentsPageByObjectIdResponse(id=1923582, encodeId=bf8f192358239, content=<a href='/topic/show?id=f9f25864447' target=_blank style='color:#2F92EE;'>#新药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58644, encryptionId=f9f25864447, topicName=新药物)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIuNQXObUwZmFG3VcZa2uhFq27sY7vfTowUhQCgRj2bj1odUibMF4sFXpuRLf6IE5t5yGVDSiaOoOcQ/132, createdBy=1e622500088, createdName=ms1065684921169360, createdTime=Sat Jun 25 14:26:00 CST 2016, time=2016-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1738502, encodeId=0ca41e385029a, content=<a href='/topic/show?id=a9dd4e63c4' target=_blank style='color:#2F92EE;'>#CIT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4763, encryptionId=a9dd4e63c4, topicName=CIT)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=eabf34462441, createdName=12498877m109暂无昵称, createdTime=Mon Jan 16 10:26:00 CST 2017, time=2017-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1265293, encodeId=742212652937d, content=<a href='/topic/show?id=57a53011364' target=_blank style='color:#2F92EE;'>#关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30113, encryptionId=57a53011364, topicName=关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f90281, createdName=lmm397, createdTime=Sun Apr 03 00:26:00 CST 2016, time=2016-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1333800, encodeId=e9b8133380017, content=<a href='/topic/show?id=5306e6164b6' target=_blank style='color:#2F92EE;'>#类风湿#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76164, encryptionId=5306e6164b6, topicName=类风湿)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83eq2AGzrugK9ZUjU3eJxzM901ophWib0xJDrSicy49ibWl3zB5pbDto7eoR6tnzwOiaKdbq1a8PcbYFFrw/132, createdBy=6ff22500098, createdName=ms4964546379600229, createdTime=Sun Apr 03 00:26:00 CST 2016, time=2016-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1483397, encodeId=3126148339e39, content=<a href='/topic/show?id=55a6100826cc' target=_blank style='color:#2F92EE;'>#风湿性关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=100826, encryptionId=55a6100826cc, topicName=风湿性关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5c237911872, createdName=ms1467340776200723, createdTime=Sun Apr 03 00:26:00 CST 2016, time=2016-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1528311, encodeId=028d1528311d7, content=<a href='/topic/show?id=74b798601a1' target=_blank style='color:#2F92EE;'>#难治性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98601, encryptionId=74b798601a1, topicName=难治性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1ef11916292, createdName=freve, createdTime=Sun Apr 03 00:26:00 CST 2016, time=2016-04-03, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1923582, encodeId=bf8f192358239, content=<a href='/topic/show?id=f9f25864447' target=_blank style='color:#2F92EE;'>#新药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58644, encryptionId=f9f25864447, topicName=新药物)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIuNQXObUwZmFG3VcZa2uhFq27sY7vfTowUhQCgRj2bj1odUibMF4sFXpuRLf6IE5t5yGVDSiaOoOcQ/132, createdBy=1e622500088, createdName=ms1065684921169360, createdTime=Sat Jun 25 14:26:00 CST 2016, time=2016-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1738502, encodeId=0ca41e385029a, content=<a href='/topic/show?id=a9dd4e63c4' target=_blank style='color:#2F92EE;'>#CIT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4763, encryptionId=a9dd4e63c4, topicName=CIT)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=eabf34462441, createdName=12498877m109暂无昵称, createdTime=Mon Jan 16 10:26:00 CST 2017, time=2017-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1265293, encodeId=742212652937d, content=<a href='/topic/show?id=57a53011364' target=_blank style='color:#2F92EE;'>#关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30113, encryptionId=57a53011364, topicName=关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f90281, createdName=lmm397, createdTime=Sun Apr 03 00:26:00 CST 2016, time=2016-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1333800, encodeId=e9b8133380017, content=<a href='/topic/show?id=5306e6164b6' target=_blank style='color:#2F92EE;'>#类风湿#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76164, encryptionId=5306e6164b6, topicName=类风湿)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83eq2AGzrugK9ZUjU3eJxzM901ophWib0xJDrSicy49ibWl3zB5pbDto7eoR6tnzwOiaKdbq1a8PcbYFFrw/132, createdBy=6ff22500098, createdName=ms4964546379600229, createdTime=Sun Apr 03 00:26:00 CST 2016, time=2016-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1483397, encodeId=3126148339e39, content=<a href='/topic/show?id=55a6100826cc' target=_blank style='color:#2F92EE;'>#风湿性关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=100826, encryptionId=55a6100826cc, topicName=风湿性关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5c237911872, createdName=ms1467340776200723, createdTime=Sun Apr 03 00:26:00 CST 2016, time=2016-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1528311, encodeId=028d1528311d7, content=<a href='/topic/show?id=74b798601a1' target=_blank style='color:#2F92EE;'>#难治性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98601, encryptionId=74b798601a1, topicName=难治性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1ef11916292, createdName=freve, createdTime=Sun Apr 03 00:26:00 CST 2016, time=2016-04-03, status=1, ipAttribution=)]
    2016-04-03 freve
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