NEJM:罗氟司特局部乳膏治疗慢性斑块状牛皮癣的2b期阳性结果

2020-07-16 MedSci原创 MedSci原创

2b期临床结果显示,每天一次ARQ-151(罗氟司特乳膏)明显改善牛皮癣患者的体征和症状。

Arcutis Biotherapeutics公司宣布,《新英格兰医学杂志》(NEJM)发表其局部用罗氟司特乳膏治疗慢性斑块状牛皮癣的 2b期临床阳性结果。

See the source image

关于ARQ-151(局部罗氟司特乳膏)

局部罗氟司特乳膏是每日一次的局部乳膏制剂,其中含有Roflumilast(一种PDE4抑制剂),Arcutis正在开发该制剂用于治疗斑块状牛皮癣,包括三叉性牛皮癣和特应性皮炎。PDE4是一种细胞内酶,可调节促炎和抗炎细胞因子的产生以及细胞增殖。

罗氟司特于2011年被FDA批准用于全身治疗,以降低慢性阻塞性肺疾病(COPD)加重的风险,并且比皮肤病学中使用的其他两种FDA批准的PDE4抑制剂具有更高的药效(25-300倍)。

关于牛皮癣

牛皮癣是一种免疫疾病,西方国家成人发病路为2%。大约90%的牛皮癣病例是斑块状牛皮癣,其特征是皮肤上的“斑块”或凸起的红色区域被银或白色鳞片覆盖。银屑病斑块可出现在身体的任何部位,但最常见于头皮,膝盖,肘部,躯干和四肢,并且斑块通常发痒,有时会疼痛。

关于2b期临床

2b期临床结果显示,每天一次ARQ-151(罗氟司特乳膏)的治疗显示出牛皮癣体征和症状的明显改善。

研究者全球评估(IGA)评分的主要功效终点表明,在第6周,罗氟司特0.3%,罗氟司特0.15%和赋形剂分别为28%,23%和8%(p <0.001和p = 0.004)。

第12周时,罗氟司特0.3%,罗氟司特0.15%和赋形剂比率分别为31%、27%和14%。

在15%基线三叉性银屑病至少为轻度严重的患者中,接受罗氟司特0.3%治疗的15例患者中有14例(93%)在第12周的Intertriginous-IGA评分为0(清晰),而赋形剂组为17例患者中的3例(18%)实现该指标。

在第12周时,罗氟司特0.3%的PASI-75响应率(相对于基线,PASI改善至少75%)为34%,而赋形剂组为16%。

罗氟司特乳膏组中的应用部位反应不如赋形剂组组中常见。百分之九十七的不良事件被定为轻度或中度。

皮肤病学总监Linda Stein Gold博士说:“这项研究的积极结果表明,罗氟司特乳膏使得患者的皮肤清晰度、瘙痒和疾病负担得到统计学意义的改善。并且,局部使用罗氟司特乳膏早在两周内就显示出显着疗效,在整个研究过程中耐受良好。”

原始出处:

https://www.firstwordpharma.com/node/1740920?tsid=28&region_id=4

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    2020-07-20 老婆子

    治疗牛皮藓

    0

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  5. [GetPortalCommentsPageByObjectIdResponse(id=1642068, encodeId=323a164206815, content=<a href='/topic/show?id=679b9e514c8' target=_blank style='color:#2F92EE;'>#阳性结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97514, encryptionId=679b9e514c8, topicName=阳性结果)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=28fb22837833, createdName=12498cb5m20暂无昵称, createdTime=Mon Oct 19 09:50:15 CST 2020, time=2020-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=803544, encodeId=ff2a803544fe, content=治疗牛皮藓, beContent=null, objectType=article, channel=null, level=null, likeNumber=116, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200720/956eb01f4b594ee783debae7a44d9096/e569cb8381764328b493c23491d86c27.jpg, createdBy=2cbc5401622, createdName=老婆子, createdTime=Mon Jul 20 20:24:42 CST 2020, time=2020-07-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1934130, encodeId=b3d819341305e, content=<a href='/topic/show?id=6e32e9618ba' target=_blank style='color:#2F92EE;'>#罗氟司特#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79618, encryptionId=6e32e9618ba, topicName=罗氟司特)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec53439, createdName=zhty5337, createdTime=Sun Jun 27 03:50:15 CST 2021, time=2021-06-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1321091, encodeId=378a132109178, content=<a href='/topic/show?id=2a136e77095' target=_blank style='color:#2F92EE;'>#牛皮癣#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=67770, encryptionId=2a136e77095, topicName=牛皮癣)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c2e485, createdName=yangfl06, createdTime=Sat Jul 18 00:50:15 CST 2020, time=2020-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1330151, encodeId=62d2133015189, content=<a href='/topic/show?id=a91c5e92328' target=_blank style='color:#2F92EE;'>#斑块#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57923, encryptionId=a91c5e92328, topicName=斑块)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/4E6244DB7C1860858424437821E08291/100, createdBy=a6a52500039, createdName=ms3994565386320060, createdTime=Sat Jul 18 00:50:15 CST 2020, time=2020-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405985, encodeId=00da140598521, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Sat Jul 18 00:50:15 CST 2020, time=2020-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035342, encodeId=91a7103534257, 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=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Jul 16 12:50:15 CST 2020, time=2020-07-16, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1642068, encodeId=323a164206815, content=<a href='/topic/show?id=679b9e514c8' target=_blank style='color:#2F92EE;'>#阳性结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97514, encryptionId=679b9e514c8, topicName=阳性结果)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=28fb22837833, createdName=12498cb5m20暂无昵称, createdTime=Mon Oct 19 09:50:15 CST 2020, time=2020-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=803544, encodeId=ff2a803544fe, content=治疗牛皮藓, beContent=null, objectType=article, channel=null, level=null, likeNumber=116, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200720/956eb01f4b594ee783debae7a44d9096/e569cb8381764328b493c23491d86c27.jpg, createdBy=2cbc5401622, createdName=老婆子, createdTime=Mon Jul 20 20:24:42 CST 2020, time=2020-07-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1934130, encodeId=b3d819341305e, content=<a href='/topic/show?id=6e32e9618ba' target=_blank style='color:#2F92EE;'>#罗氟司特#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79618, encryptionId=6e32e9618ba, topicName=罗氟司特)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec53439, createdName=zhty5337, createdTime=Sun Jun 27 03:50:15 CST 2021, time=2021-06-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1321091, encodeId=378a132109178, content=<a href='/topic/show?id=2a136e77095' target=_blank style='color:#2F92EE;'>#牛皮癣#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=67770, encryptionId=2a136e77095, topicName=牛皮癣)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c2e485, createdName=yangfl06, createdTime=Sat Jul 18 00:50:15 CST 2020, time=2020-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1330151, encodeId=62d2133015189, content=<a href='/topic/show?id=a91c5e92328' target=_blank style='color:#2F92EE;'>#斑块#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57923, encryptionId=a91c5e92328, topicName=斑块)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/4E6244DB7C1860858424437821E08291/100, createdBy=a6a52500039, createdName=ms3994565386320060, createdTime=Sat Jul 18 00:50:15 CST 2020, time=2020-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405985, encodeId=00da140598521, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Sat Jul 18 00:50:15 CST 2020, time=2020-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035342, encodeId=91a7103534257, 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=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Jul 16 12:50:15 CST 2020, time=2020-07-16, status=1, ipAttribution=)]
    2020-07-18 chg122
  7. [GetPortalCommentsPageByObjectIdResponse(id=1642068, encodeId=323a164206815, content=<a href='/topic/show?id=679b9e514c8' target=_blank style='color:#2F92EE;'>#阳性结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97514, encryptionId=679b9e514c8, topicName=阳性结果)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=28fb22837833, createdName=12498cb5m20暂无昵称, createdTime=Mon Oct 19 09:50:15 CST 2020, time=2020-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=803544, encodeId=ff2a803544fe, content=治疗牛皮藓, beContent=null, objectType=article, channel=null, level=null, likeNumber=116, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200720/956eb01f4b594ee783debae7a44d9096/e569cb8381764328b493c23491d86c27.jpg, createdBy=2cbc5401622, createdName=老婆子, createdTime=Mon Jul 20 20:24:42 CST 2020, time=2020-07-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1934130, encodeId=b3d819341305e, content=<a href='/topic/show?id=6e32e9618ba' target=_blank style='color:#2F92EE;'>#罗氟司特#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79618, encryptionId=6e32e9618ba, topicName=罗氟司特)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec53439, createdName=zhty5337, createdTime=Sun Jun 27 03:50:15 CST 2021, time=2021-06-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1321091, encodeId=378a132109178, content=<a href='/topic/show?id=2a136e77095' target=_blank style='color:#2F92EE;'>#牛皮癣#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=67770, encryptionId=2a136e77095, topicName=牛皮癣)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c2e485, createdName=yangfl06, createdTime=Sat Jul 18 00:50:15 CST 2020, time=2020-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1330151, encodeId=62d2133015189, content=<a href='/topic/show?id=a91c5e92328' target=_blank style='color:#2F92EE;'>#斑块#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57923, encryptionId=a91c5e92328, topicName=斑块)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/4E6244DB7C1860858424437821E08291/100, createdBy=a6a52500039, createdName=ms3994565386320060, createdTime=Sat Jul 18 00:50:15 CST 2020, time=2020-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405985, encodeId=00da140598521, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Sat Jul 18 00:50:15 CST 2020, time=2020-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035342, encodeId=91a7103534257, 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=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Jul 16 12:50:15 CST 2020, time=2020-07-16, status=1, ipAttribution=)]
    2020-07-16 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