JAMA:IL-23 抑制剂Risankizumab 对中度至重度银屑病患者治疗结果的影响

2021-09-03 医路坦克 MedSci原创

斑块状银屑病是一种慢性免疫介导的全身性疾病,其特征厚厚的皮肤上覆盖着干燥和银色鳞屑(斑块),通常伴有灼烧感、瘙痒和疼痛。斑块的外观表现经常导致患者心理困扰。

Risankizumab (ABBV-066) 是一种抗 IL-23 单克隆抗体药物,目前,原研艾伯维正在进行研究其用于治疗多种炎症性疾病,包括银屑病、克罗恩病、溃疡性结肠炎、特应性皮炎和银屑病关节炎。

斑块状银屑病是一种慢性免疫介导的全身性疾病,其特征厚厚的皮肤上覆盖着干燥和银色鳞屑(斑块),通常伴有灼烧感、瘙痒和疼痛。斑块的外观表现经常导致患者心理困扰。其身体和心理社会负担会严重损害社会功能、工作和日常活动以及健康—许多银屑病患者的相关生活质量 (HRQL),

Risankizumab 是一种白细胞介素 (IL)-23 抑制剂,是一种在美国和欧洲获得批准的新型人源化 IgG1 单克隆抗体。两个3期重复临床试验证明,Risankizumab 优于 IL-12/23 抑制剂乌司奴单抗,同时保持与优特克单抗相似的良好安全性。第 16 周的皮肤病生活质量指数 (DLQI) 和银屑病症状量表 (PSS) 被列为次要终点。本研究在这2个3期试验中通过 PRO 从患者的角度报告了一段时间内的治疗效果。

UltIMMa-1 和 UltIMMa-2 研究是重复的 52 周第 3 期、随机、多中心、双盲、安慰剂对照和活性对照药对照试验,分别在在亚太、日本、欧洲和北美的全球 139 个站点(包括医院、学术医疗中心、临床研究单位和私人诊所)。患有中度至重度慢性斑块状银屑病且体表面积 (BSA) 占 10% 或更多、银屑病面积严重程度指数 (PASI) 得分为 12 或更高、静态医师总体评估 (sPGA) 得分为 3 的成人(18 岁)或更高的都包括在内。

干预:在每项试验中,患者被随机分配 (3:1:1) 接受 150 mg Risankizumab、45 mg 或 90 mg 优特克单抗(每个标签基于体重)52 周,或匹配安慰剂 16 周,然后是 Risankizumab。

主要结果和测量:来自 2 项试验的综合数据用于比较银屑病症状量表 (PSS)(疼痛、发红、发痒和灼痛的总分和项目评分) )、皮肤科生活质量指数 (DLQI)、5 级 EuroQoL-5D (EQ-5D-5L) 和医院焦虑和抑郁量表 (HADS),开始、第 16 周和第 52 周。

结果:共分析了 997 名中度至重度慢性斑块状银屑病患者。在所有组中,平均年龄为 47.2 至 47.8 岁,68.3%(优特克单抗为 136/199)至 73.0%(安慰剂为 146/200)为男性。基线时所有治疗组的患者特征和 PRO 具有可比性(Risankizumab、Ustekinumab 和安慰剂分别为 n = 598、199、200)。在第 16 周,与使用优特克单抗或安慰剂治疗的患者相比,接受 Risankizumab 治疗的患者达到 PSS = 0 的比例显着更高,表明没有银屑病症状(30.3% [181/598]、15.1% [30/199]、1.0% [2] /200],两者 P<.001),DLQI = 0 或 1 表示对皮肤相关 HRQL 没有影响(66.2%、44.7%、6.0%,P<.001)。与优特克单抗或安慰剂相比,接受 Risankizumab 治疗的患者在 DLQI 方面达到最小临床重要差异 (MCID) 的比例显着更高(94.5% [516/546]、85.1% [149/175]、35.6% [64/180];两者 P< . 001)、EQ-5D-5L(41.7% [249/597] 对 31.5% [62/197],P= .01;对 19.0% [38/200],P< .001)和 HADS(焦虑: 69.1% [381/551] vs 57.1% [104/182],P= .004;vs 35.9% [66/184],P< .001;抑郁:71.1% [354/598] vs 60.4% [96/ 159],P= .01;对比 37.1% [59/159],P< .001)。在第 52 周时,与使用优特克单抗治疗的患者相比,接受 Risankizumab 治疗的患者在 PSS、DLQI 和 EQ-5D-5L 方面的改善持续。

结论和相关性

Risankizumab 显着改善了中度至重度银屑病的症状,与优特克单抗或安慰剂相比,改善了 HRQL,并减少了心理困扰。

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    2022-06-02 snf701207
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    2021-09-05 tomyang93
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    2022-07-24 jklm09
  7. [GetPortalCommentsPageByObjectIdResponse(id=1796935, encodeId=487e1e96935c4, content=<a href='/topic/show?id=bf162214668' target=_blank style='color:#2F92EE;'>#中度至重度#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22146, encryptionId=bf162214668, topicName=中度至重度)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=de89102, createdName=liuyong2980, createdTime=Sat Jul 30 17:33:34 CST 2022, time=2022-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912672, encodeId=332b19126e2fb, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Thu Jun 02 17:33:34 CST 2022, time=2022-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1479667, encodeId=6e5214e9667bd, content=<a href='/topic/show?id=6e0e9655fd' target=_blank style='color:#2F92EE;'>#IL-23#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9655, encryptionId=6e0e9655fd, topicName=IL-23)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=9e8f7562522, createdName=124987a0m68(暂无昵称), createdTime=Sun Sep 05 13:33:34 CST 2021, time=2021-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1535951, encodeId=25d71535951e3, content=<a href='/topic/show?id=ae716469300' target=_blank style='color:#2F92EE;'>#治疗结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64693, encryptionId=ae716469300, topicName=治疗结果)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fa8e12645559, createdName=jiadan198786, createdTime=Sun Sep 05 13:33:34 CST 2021, time=2021-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1626073, encodeId=2c1c16260e339, content=<a href='/topic/show?id=87369652f3' target=_blank style='color:#2F92EE;'>#IL-2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9652, encryptionId=87369652f3, topicName=IL-2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ea8220955712, createdName=tomyang93, createdTime=Sun Sep 05 13:33:34 CST 2021, time=2021-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852745, encodeId=845b1852e458a, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Sun Jul 24 03:33:34 CST 2022, time=2022-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036817, encodeId=5e3a103681ed5, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Sat Sep 04 01:33:34 CST 2021, time=2021-09-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1014418, encodeId=0bf81014418f1, content=<a href='/topic/show?id=58ee1549925' target=_blank style='color:#2F92EE;'>#risankizumab#</a><a href='/topic/show?id=d4d196630b4' target=_blank style='color:#2F92EE;'>#银屑病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=146, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15499, encryptionId=58ee1549925, topicName=risankizumab), TopicDto(id=96630, encryptionId=d4d196630b4, topicName=银屑病)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211210/ede9c51184aa4f54ae6c1164cfb8eeac/967dbf3eff2943c7bf3ccfec3a776ab0.JPG, createdBy=a33789389, createdName=病毒猎手, createdTime=Fri Sep 03 23:06:01 CST 2021, time=2021-09-03, status=1, ipAttribution=)]
    2021-09-04 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=1796935, encodeId=487e1e96935c4, content=<a href='/topic/show?id=bf162214668' target=_blank style='color:#2F92EE;'>#中度至重度#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22146, encryptionId=bf162214668, topicName=中度至重度)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=de89102, createdName=liuyong2980, createdTime=Sat Jul 30 17:33:34 CST 2022, time=2022-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912672, encodeId=332b19126e2fb, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Thu Jun 02 17:33:34 CST 2022, time=2022-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1479667, encodeId=6e5214e9667bd, content=<a href='/topic/show?id=6e0e9655fd' target=_blank style='color:#2F92EE;'>#IL-23#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9655, encryptionId=6e0e9655fd, topicName=IL-23)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=9e8f7562522, createdName=124987a0m68(暂无昵称), createdTime=Sun Sep 05 13:33:34 CST 2021, time=2021-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1535951, encodeId=25d71535951e3, content=<a href='/topic/show?id=ae716469300' target=_blank style='color:#2F92EE;'>#治疗结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64693, encryptionId=ae716469300, topicName=治疗结果)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fa8e12645559, createdName=jiadan198786, createdTime=Sun Sep 05 13:33:34 CST 2021, time=2021-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1626073, encodeId=2c1c16260e339, content=<a href='/topic/show?id=87369652f3' target=_blank style='color:#2F92EE;'>#IL-2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9652, encryptionId=87369652f3, topicName=IL-2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ea8220955712, createdName=tomyang93, createdTime=Sun Sep 05 13:33:34 CST 2021, time=2021-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852745, encodeId=845b1852e458a, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Sun Jul 24 03:33:34 CST 2022, time=2022-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036817, encodeId=5e3a103681ed5, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Sat Sep 04 01:33:34 CST 2021, time=2021-09-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1014418, encodeId=0bf81014418f1, content=<a href='/topic/show?id=58ee1549925' target=_blank style='color:#2F92EE;'>#risankizumab#</a><a href='/topic/show?id=d4d196630b4' target=_blank style='color:#2F92EE;'>#银屑病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=146, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15499, encryptionId=58ee1549925, topicName=risankizumab), TopicDto(id=96630, encryptionId=d4d196630b4, topicName=银屑病)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211210/ede9c51184aa4f54ae6c1164cfb8eeac/967dbf3eff2943c7bf3ccfec3a776ab0.JPG, createdBy=a33789389, createdName=病毒猎手, createdTime=Fri Sep 03 23:06:01 CST 2021, time=2021-09-03, status=1, ipAttribution=)]

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