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Ann Rheum Dis:bimekizumab双重中和白介素-17A和17F治疗活动性强直性脊柱炎

2020-04-08 xiangting MedSci原创

Bimekizumab可以快速、持续地改善活动性AS患者的关键结局指标。与既往研究相比,没有意外的安全性发现。

Bimekizumab选择性中和白介素(IL)-17A和IL-17F。这里报告了一项IIb期剂量范围研究中,bimekizumab治疗活动性强直性脊柱炎(AS)的疗效和安全性。

将成年AS患者(符合修改后的纽约标准)按1:1:1:1:1的比例随机分为每4周bimekizumab 16mg、64mg、160mg、320mg或安慰剂组,共12周(双盲期)。第12周时,将bimekizumab 16mg、64mg或安慰剂组的患者按1:1重新随机分至每4周bimekizumab 160mg或320mg,直至48周。其他患者继续其初始剂量(剂量盲期)。主要终点是第12周的国际脊柱关节炎评估协会(ASAS)40应答(缺失数据使用无应答插补(NRI))。

303例患者被随机分组​​:bimekizumab 16mg(n=61),64mg(n=61),160mg(n=60),320mg(n=61)或安慰剂(n=60)。第12周时,bimekizumab治疗的患者达到ASAS40的数量明显多于安慰剂组(NRI:29.5%-46.7% vs 13.3%;p均<0.05;OR vs安慰剂2.6-5.5(95%CI 1.0-12.9))。观察到明显的剂量-应答(p<0.001)。主要终点得到所有次要疗效结局的支持。第48周,整个研究期间接受bimekizumab 160和320mg治疗的患者分别有58.6%和62.3%达到ASAS40(NRI);再次随机分组患者中观察到相似的ASAS40应答率。双盲期间,安慰剂组26/60例患者(43.3%)和bimekizumab组92/243例患者(37.9%)出现了需要治疗的不良事件。

Bimekizumab可以快速、持续地改善活动性AS患者的关键结局指标。与既往研究相比,没有意外的安全性发现。

原始出处:

Désirée van der Heijde. Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase IIb, randomised, double-blind, placebo-controlled, dose-ranging study. Ann Rheum Dis. April 2020.

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    2020-06-05 snf701207
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2020, time=2020-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372135, encodeId=8cc113e2135dd, 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=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71621, encryptionId=6ca1e1621c4, topicName=白介素)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Fri Apr 10 04:09:14 CST 2020, time=2020-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440405, encodeId=e77e144040593, content=<a href='/topic/show?id=6f0e845427f' target=_blank style='color:#2F92EE;'>#脊柱炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84542, encryptionId=6f0e845427f, topicName=脊柱炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50834728424, createdName=1249898am16暂无昵称, createdTime=Fri Apr 10 04:09:14 CST 2020, time=2020-04-10, status=1, ipAttribution=)]
    2020-09-16 zywlvao
  5. 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2020, time=2020-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372135, encodeId=8cc113e2135dd, 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=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71621, encryptionId=6ca1e1621c4, topicName=白介素)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Fri Apr 10 04:09:14 CST 2020, time=2020-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440405, encodeId=e77e144040593, content=<a href='/topic/show?id=6f0e845427f' target=_blank style='color:#2F92EE;'>#脊柱炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84542, encryptionId=6f0e845427f, topicName=脊柱炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50834728424, createdName=1249898am16暂无昵称, createdTime=Fri Apr 10 04:09:14 CST 2020, time=2020-04-10, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1651342, encodeId=59fb165134251, 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=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71622, encryptionId=6eefe162275, topicName=白介素-1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=859f24174096, createdName=zhangph, createdTime=Tue Jun 23 03:09:14 CST 2020, time=2020-06-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1723999, encodeId=eee51e2399981, content=<a href='/topic/show?id=2d996516e7c' target=_blank style='color:#2F92EE;'>#活动性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65167, encryptionId=2d996516e7c, topicName=活动性)], attachment=null, authenticateStatus=null, createdAvatar=null, 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encodeId=3cea20132e899, content=<a href='/topic/show?id=7d69598468' target=_blank style='color:#2F92EE;'>#Dis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5984, encryptionId=7d69598468, topicName=Dis)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c689267, createdName=cmj8wellington, createdTime=Tue Aug 04 18:09:14 CST 2020, time=2020-08-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1943910, encodeId=2b2f1943910a4, content=<a href='/topic/show?id=d2af1152597' target=_blank style='color:#2F92EE;'>#MEK#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11525, encryptionId=d2af1152597, topicName=MEK)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b0e350, createdName=naiwu77, createdTime=Mon Nov 09 15:09:14 CST 2020, time=2020-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372135, encodeId=8cc113e2135dd, 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=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71621, encryptionId=6ca1e1621c4, topicName=白介素)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Fri Apr 10 04:09:14 CST 2020, time=2020-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440405, encodeId=e77e144040593, content=<a href='/topic/show?id=6f0e845427f' target=_blank style='color:#2F92EE;'>#脊柱炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84542, encryptionId=6f0e845427f, topicName=脊柱炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50834728424, createdName=1249898am16暂无昵称, createdTime=Fri Apr 10 04:09:14 CST 2020, time=2020-04-10, status=1, ipAttribution=)]
  7. 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encodeId=3cea20132e899, content=<a href='/topic/show?id=7d69598468' target=_blank style='color:#2F92EE;'>#Dis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5984, encryptionId=7d69598468, topicName=Dis)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c689267, createdName=cmj8wellington, createdTime=Tue Aug 04 18:09:14 CST 2020, time=2020-08-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1943910, encodeId=2b2f1943910a4, content=<a href='/topic/show?id=d2af1152597' target=_blank style='color:#2F92EE;'>#MEK#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11525, encryptionId=d2af1152597, topicName=MEK)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b0e350, createdName=naiwu77, createdTime=Mon Nov 09 15:09:14 CST 2020, time=2020-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372135, encodeId=8cc113e2135dd, 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=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71621, encryptionId=6ca1e1621c4, topicName=白介素)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Fri Apr 10 04:09:14 CST 2020, time=2020-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440405, encodeId=e77e144040593, content=<a href='/topic/show?id=6f0e845427f' target=_blank style='color:#2F92EE;'>#脊柱炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84542, encryptionId=6f0e845427f, topicName=脊柱炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50834728424, createdName=1249898am16暂无昵称, createdTime=Fri Apr 10 04:09:14 CST 2020, time=2020-04-10, status=1, ipAttribution=)]
    2020-11-09 naiwu77
  8. 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