Lancet Rheumatology:Guselkumab对活动性银屑病关节炎和骶髂关节炎患者中轴受累的疗效

2021-10-24 MedSci原创 MedSci原创

与接受安慰剂治疗的参与者相比,每4周或每8周接受guselkumab治疗的活动性银屑病关节炎和影像学证实的骶髂关节炎患者在BASDAI和ASDAS方面的平均改善更大(早在第8周),并在第52周持续改善

     在3DISCOVER-1DISCOVER-2研究中,Guselkumab可有效减轻银屑病关节炎的体征和症状。该研究旨在评估guselkumab在银屑病关节炎患者的事后分析中的疗效,这些患者的影像学证实为骶髂关节炎,与轴向受累一致。

     在DISCOVER-1中,381名活动性银屑病关节炎患者(定义为≥3个关节肿胀、≥3 个触痛关节和C反应蛋白[CRP]0.3 mg/dL),在DISCOVER-2中,739名活动性银屑病关节炎患者(定义为≥5个关节肿胀、≥5个触痛关节和CRP0.6 mg/dL)被随机分配接受每4周一次100 mg guselkumab、每8周一次guselkumab 100 mg(第0周、第4周、然后每8周),或安慰剂。这些汇总的事后分析包括在筛查时通过先前影像学或盆腔放射学检查记录的与骶髂关节炎一致的轴向疾病患者(由研究者确认)。疗效评估包括巴斯强直性脊柱炎疾病活动指数(BASDAI)评分、改良BASDAI (mBASDAI;不包括外周关节疼痛)、脊柱疼痛和强直性脊柱炎疾病活动评分 (ASDAS) 的最小二乘均值变化,95% CI,以及BASDAI评分(BASDAI50)至少改善50%并达到非活动性疾病ASDAS反应(评分 <1.3)、明显改善(≥2.0 的变化)和临床重要改善(≥1.1 的变化)的患者比例

     在两项DISCOVER研究的1120名患者中,312(28%)被纳入该分析,其中118名在安慰剂组中,103名在每4周一次的guselkumab组中,91名在每8周一次的guselkumab组中。男性191人(61%),女性121人(39%),平均年龄45.1SD 11.2)。在190名患者中评估了HLA-B27状态;57(30%) HLA-B27阳性,133(70%) HLA-B27阴性。在第24周时,两个guselkumab组的BASDAI最小二乘基线均值变化为-2.795%CI -3.2-2.2),安慰剂组 -1.3-1.8-0.9 ) mBASDAI和脊柱疼痛也观察到了类似的结果。两个guselkumab组在第24ASDAS评分的最小二乘平均变化为-1.495% CI -1.7-1.2),安慰剂为-0.795%CI -0.9-0.5)。在第24周时,每4周一次guselkumab组中的 36(38%)患者和每8周一次guselkumab组中的34(40%)患者达到BASDAI50,而安慰剂患者为21 (19%);与安慰剂相比,接受Guselkumab治疗的患者达到ASDAS反应的比例更高。在所有结果中,在第8周观察到与安慰剂的分离。在第24周观察到Guselkumab改善与 HLA-B27状态无关。Guselkumab组这些改善在第52周时得以保持。

     结论:与接受安慰剂治疗的参与者相比,每4周或每8周接受guselkumab治疗的活动性银屑病关节炎和影像学证实的骶髂关节炎患者在BASDAIASDAS方面的平均改善更大(早在第8周),并在第52周持续改善。 

出处:

P.J. Mease, P.S. Helliwell, D.D. Gladman, D. Poddubnyy, X. Baraliakos, S.D. Chakravarty, A.P. Kollmeier, E.C. Hsia, X.L. Xu, S. Sheng, P. Agarwal, B. Zhou, K. Sweet, M. Shawi, C.S. Karyekar, A. Deodhar, D. van der Heijde, Efficacy of guselkumab on axial involvement in patients with active psoriatic arthritis and sacroiliitis: a post-hoc analysis of the phase 3 DISCOVER-1 and DISCOVER-2 studies, The Lancet Rheumatology. 3 (2021) e715-e723.

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createdName=ms7405317358118777, createdTime=Tue Oct 26 00:48:53 CST 2021, time=2021-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1063420, encodeId=2aba106342043, content=学习了,不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=31135620079, createdName=红土豆瓣酱, createdTime=Sun Oct 24 11:33:02 CST 2021, time=2021-10-24, status=1, ipAttribution=)]
    2022-04-26 zhaojie88
  4. 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  5. 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encodeId=181e149100195, content=<a href='/topic/show?id=779c6518253' target=_blank style='color:#2F92EE;'>#活动性银屑病关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65182, encryptionId=779c6518253, topicName=活动性银屑病关节炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ef878855116, createdName=nian.wang1985, createdTime=Tue Oct 26 00:48:53 CST 2021, time=2021-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1618613, encodeId=cfd6161861343, content=<a href='/topic/show?id=a533102040f0' target=_blank style='color:#2F92EE;'>#骶髂关节#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102040, encryptionId=a533102040f0, topicName=骶髂关节)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ea8919912031, createdName=ms7405317358118777, createdTime=Tue Oct 26 00:48:53 CST 2021, time=2021-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1063420, encodeId=2aba106342043, content=学习了,不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=31135620079, createdName=红土豆瓣酱, createdTime=Sun Oct 24 11:33:02 CST 2021, time=2021-10-24, status=1, ipAttribution=)]
    2021-10-26 lmm397
  6. 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  7. 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  8. 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  9. 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    2021-10-24 红土豆瓣酱

    学习了,不错

    0