J Rheumatol:静脉注射戈利木单抗治疗成人强直性脊柱炎的安全性和疗效:GO-ALIVE研究28周结果

2017-12-21 xiangting MedSci原创

在第0,4周和每8周静脉注射GOL 2mg / kg显著降低成人AS的体征和症状。

这项研究旨在评价静脉注射戈利木单抗(GOL)治疗活动性强直性脊柱炎(AS)的安全性和疗效。

在III期随机双盲安慰剂(PBO)对照试验中,208名患者被随机(1:1)分为第0,4,12周静注GOL 2 mg / kg(n = 105)和每8周输注,或在第0,4,12周PBO(n = 103),第16周转为GOL。主要终点是第16周脊柱关节炎国际协会标准评估从基线改善≥20%。次要终点包括ASAS40,Bath强直性脊柱炎疾病活动指数(BASDAI50)≥50%改善,以及第16周Bath强直性脊柱炎功能指数(BASFI)改变。28周内对安全性进行监测。

GOL治疗患者在第2周时(37.1% vs.19.4%; p = 0.005)和第16周(73.3% vs.26.2%; p <0.001)ASAS20应答比例显著更高。第16周,接受GOL治疗的患者中有41.0%达到BASDAI50,而服用PBO的患者为14.6%(P <0.001)。GOL组BASFI的平均改善更大(-2.4 vs -0.5; p <0.001)。到第16周,PBO组23.3%的患者和GOL组32.4%的患者发生≥1次不良事件(AE); 感染是最常见的AE类型。到第28周,2名GOL治疗患者有严重AE。

在第0,4周和每8周静脉注射GOL 2mg / kg显著降低成人AS的体征和症状。AE与其他抗肿瘤坏死因子疗法一致,没有新的安全信号。

原始出处:

本文系梅斯医学(MedSci)原创编译整理,转载需授权!

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (5)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1697605, encodeId=e489169e605bc, content=<a href='/topic/show?id=f2399910109' target=_blank style='color:#2F92EE;'>#静脉#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99101, encryptionId=f2399910109, topicName=静脉)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0bc129907796, createdName=fusion, createdTime=Sun Jun 10 09:03:00 CST 2018, time=2018-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1946846, encodeId=b7af1946846aa, content=<a href='/topic/show?id=9a3950183e9' target=_blank style='color:#2F92EE;'>#强直性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50183, encryptionId=9a3950183e9, topicName=强直性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKeia4TJeMGvEH3wKKIBNjuHuIic1HDNOB10j4tCd3nbylxkxm6HSMfEaKkSu6OZOak4uZv7UVicsWEg/132, createdBy=bc9a2500116, createdName=zywlvao, createdTime=Fri Jun 01 22:03:00 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440353, encodeId=7ab014403538b, 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=33, 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=Sat Dec 23 08:03:00 CST 2017, time=2017-12-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1492471, encodeId=6d4014924e1e8, content=<a href='/topic/show?id=685199141a6' target=_blank style='color:#2F92EE;'>#静脉注射#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99141, encryptionId=685199141a6, topicName=静脉注射)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=77e28942453, createdName=millore, createdTime=Sat Dec 23 08:03:00 CST 2017, time=2017-12-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1497464, encodeId=1696149e46436, content=<a href='/topic/show?id=4f465380215' target=_blank style='color:#2F92EE;'>#戈利木单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53802, encryptionId=4f465380215, topicName=戈利木单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=49569326738, createdName=FukaiBao, createdTime=Sat Dec 23 08:03:00 CST 2017, time=2017-12-23, status=1, ipAttribution=)]
    2018-06-10 fusion
  2. [GetPortalCommentsPageByObjectIdResponse(id=1697605, encodeId=e489169e605bc, content=<a href='/topic/show?id=f2399910109' target=_blank style='color:#2F92EE;'>#静脉#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99101, encryptionId=f2399910109, topicName=静脉)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0bc129907796, createdName=fusion, createdTime=Sun Jun 10 09:03:00 CST 2018, time=2018-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1946846, encodeId=b7af1946846aa, content=<a href='/topic/show?id=9a3950183e9' target=_blank style='color:#2F92EE;'>#强直性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50183, encryptionId=9a3950183e9, topicName=强直性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKeia4TJeMGvEH3wKKIBNjuHuIic1HDNOB10j4tCd3nbylxkxm6HSMfEaKkSu6OZOak4uZv7UVicsWEg/132, createdBy=bc9a2500116, createdName=zywlvao, createdTime=Fri Jun 01 22:03:00 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440353, encodeId=7ab014403538b, 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=33, 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=Sat Dec 23 08:03:00 CST 2017, time=2017-12-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1492471, encodeId=6d4014924e1e8, content=<a href='/topic/show?id=685199141a6' target=_blank style='color:#2F92EE;'>#静脉注射#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99141, encryptionId=685199141a6, topicName=静脉注射)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=77e28942453, createdName=millore, createdTime=Sat Dec 23 08:03:00 CST 2017, time=2017-12-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1497464, encodeId=1696149e46436, content=<a href='/topic/show?id=4f465380215' target=_blank style='color:#2F92EE;'>#戈利木单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53802, encryptionId=4f465380215, topicName=戈利木单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=49569326738, createdName=FukaiBao, createdTime=Sat Dec 23 08:03:00 CST 2017, time=2017-12-23, status=1, ipAttribution=)]
    2018-06-01 zywlvao
  3. [GetPortalCommentsPageByObjectIdResponse(id=1697605, encodeId=e489169e605bc, content=<a href='/topic/show?id=f2399910109' target=_blank style='color:#2F92EE;'>#静脉#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99101, encryptionId=f2399910109, topicName=静脉)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0bc129907796, createdName=fusion, createdTime=Sun Jun 10 09:03:00 CST 2018, time=2018-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1946846, encodeId=b7af1946846aa, content=<a href='/topic/show?id=9a3950183e9' target=_blank style='color:#2F92EE;'>#强直性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50183, encryptionId=9a3950183e9, topicName=强直性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKeia4TJeMGvEH3wKKIBNjuHuIic1HDNOB10j4tCd3nbylxkxm6HSMfEaKkSu6OZOak4uZv7UVicsWEg/132, createdBy=bc9a2500116, createdName=zywlvao, createdTime=Fri Jun 01 22:03:00 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440353, encodeId=7ab014403538b, 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=33, 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=Sat Dec 23 08:03:00 CST 2017, time=2017-12-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1492471, encodeId=6d4014924e1e8, content=<a href='/topic/show?id=685199141a6' target=_blank style='color:#2F92EE;'>#静脉注射#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99141, encryptionId=685199141a6, topicName=静脉注射)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=77e28942453, createdName=millore, createdTime=Sat Dec 23 08:03:00 CST 2017, time=2017-12-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1497464, encodeId=1696149e46436, content=<a href='/topic/show?id=4f465380215' target=_blank style='color:#2F92EE;'>#戈利木单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53802, encryptionId=4f465380215, topicName=戈利木单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=49569326738, createdName=FukaiBao, createdTime=Sat Dec 23 08:03:00 CST 2017, time=2017-12-23, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=1697605, encodeId=e489169e605bc, content=<a href='/topic/show?id=f2399910109' target=_blank style='color:#2F92EE;'>#静脉#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99101, encryptionId=f2399910109, topicName=静脉)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0bc129907796, createdName=fusion, createdTime=Sun Jun 10 09:03:00 CST 2018, time=2018-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1946846, encodeId=b7af1946846aa, content=<a href='/topic/show?id=9a3950183e9' target=_blank style='color:#2F92EE;'>#强直性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50183, encryptionId=9a3950183e9, topicName=强直性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKeia4TJeMGvEH3wKKIBNjuHuIic1HDNOB10j4tCd3nbylxkxm6HSMfEaKkSu6OZOak4uZv7UVicsWEg/132, createdBy=bc9a2500116, createdName=zywlvao, createdTime=Fri Jun 01 22:03:00 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440353, encodeId=7ab014403538b, 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=33, 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=Sat Dec 23 08:03:00 CST 2017, time=2017-12-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1492471, encodeId=6d4014924e1e8, content=<a href='/topic/show?id=685199141a6' target=_blank style='color:#2F92EE;'>#静脉注射#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99141, encryptionId=685199141a6, topicName=静脉注射)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=77e28942453, createdName=millore, createdTime=Sat Dec 23 08:03:00 CST 2017, time=2017-12-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1497464, encodeId=1696149e46436, content=<a href='/topic/show?id=4f465380215' target=_blank style='color:#2F92EE;'>#戈利木单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53802, encryptionId=4f465380215, topicName=戈利木单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=49569326738, createdName=FukaiBao, createdTime=Sat Dec 23 08:03:00 CST 2017, time=2017-12-23, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1697605, encodeId=e489169e605bc, content=<a href='/topic/show?id=f2399910109' target=_blank style='color:#2F92EE;'>#静脉#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99101, encryptionId=f2399910109, topicName=静脉)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0bc129907796, createdName=fusion, createdTime=Sun Jun 10 09:03:00 CST 2018, time=2018-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1946846, encodeId=b7af1946846aa, content=<a href='/topic/show?id=9a3950183e9' target=_blank style='color:#2F92EE;'>#强直性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50183, encryptionId=9a3950183e9, topicName=强直性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKeia4TJeMGvEH3wKKIBNjuHuIic1HDNOB10j4tCd3nbylxkxm6HSMfEaKkSu6OZOak4uZv7UVicsWEg/132, createdBy=bc9a2500116, createdName=zywlvao, createdTime=Fri Jun 01 22:03:00 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440353, encodeId=7ab014403538b, 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=33, 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=Sat Dec 23 08:03:00 CST 2017, time=2017-12-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1492471, encodeId=6d4014924e1e8, content=<a href='/topic/show?id=685199141a6' target=_blank style='color:#2F92EE;'>#静脉注射#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99141, encryptionId=685199141a6, topicName=静脉注射)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=77e28942453, createdName=millore, createdTime=Sat Dec 23 08:03:00 CST 2017, time=2017-12-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1497464, encodeId=1696149e46436, content=<a href='/topic/show?id=4f465380215' target=_blank style='color:#2F92EE;'>#戈利木单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53802, encryptionId=4f465380215, topicName=戈利木单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=49569326738, createdName=FukaiBao, createdTime=Sat Dec 23 08:03:00 CST 2017, time=2017-12-23, status=1, ipAttribution=)]

相关资讯

长期腰背痛须警惕,小心患上“不死的癌症”!

知晓率低、就诊率低、治疗率低,轻则致残,重则危及生命,这个号称“不死的癌症”真的有这么恐怖吗?

Ann Rheum Dis:他汀与强直性脊柱炎患者死亡风险降低相关?

2017年10月,发表在《Ann Rheum Dis》上的一项基于普通人群的队列研究,调查了强直性脊柱炎(AS)患者使用他汀的生存获益情况。研究结果表明:他汀使用与AS患者死亡风险显著降低相关,并且在普通人群的随机试验和类风湿关节炎患者的基于人群队列研究中,逆相关似乎更强。

Ann Rheum Dis:不同脊柱关节炎亚型的心律紊乱和主动脉瓣返流风险

SpA患者出现主动脉瓣返流、心律紊乱的风险升高,并且作为可能的结果,PM的风险也升高。

Ann Rheum Dis:与常规影像比较,低剂量CT可以检测强直性脊柱炎更多骨形成进展

与CR相比,ldCT覆盖AS患者的整个脊柱,并可以发现更多的新生和进展韧带骨赘形成。

Ann Rheum Dis:强直性脊柱炎患者CT 韧带骨赘评分(CTSS)的制定

使用CTSS可以可靠地评估AS患者脊柱新骨形成情况。

Med Sci Monit:中国人群IFN-γ多态性对强直性脊柱炎易感性的影响

本研究旨在探讨中国人群中干扰素γ(IFN-γ)多态性和表达谱对强直性脊柱炎(AS)易感性的影响。研究人员从89例AS患者和106例健康对照组中收集血样。通过聚合酶链反应(PCR)和测序方法对IFN-γ多态性进行基因分型。通过哈迪-温伯格平衡(HWE)检测对照组多态性的基因型分布。使用χ2检验计算具有95%置信区间(95%CI)及比值比(OR),以评估AS易感性和IFN-γ多态性之间的关联。此外,通