TREMFYA(guselkumab)治疗活动性银屑病关节炎(PsA):已获得CHMP的积极意见

2020-10-19 Allan MedSci原创

Guselkumab是一种单克隆抗体,可选择性结合白介素(IL)-23的p19亚基并抑制其与IL-23受体的相互作用。

活动性银屑病关节炎(PsA)是一种慢性、免疫介导的炎症性疾病,其特征是除了皮炎、乳腺炎、轴突疾病和牛皮癣相关的皮肤病变外,还会使关节受损和发炎。目前尚无治愈方法,据估计,在欧洲1400万银屑病患者中,多达三分之一的人还将继续发展为PsA。

IL-23是诸如PsA、银屑病等炎症性疾病发病机制的重要驱动力。Guselkumab是一种单克隆抗体,可选择性结合白介素(IL)-23的p19亚基并抑制其与IL-23受体的相互作用。

强生制药公司近日宣布,欧洲药品管理局(EMA)的人用药品委员会(CHMP)建议扩大使用TREMFYA(guselkumab)治疗活动性银屑病关节炎(PsA)成人患者。Guselkumab目前已在欧盟获得批准,可用于治疗全身性中度至重度斑块状银屑病。

格拉斯哥大学Iain McInnes教授说:“银屑病关节炎是一种目前无法治愈的疾病。需要长期控制关节、皮肤和软组织的各种症状。如果获得批准,guselkumab将成为我们治疗该疾病的全新疗法”。

 

原始出处:

https://www.firstwordpharma.com/node/1766086?tsid=4

评论区 (13)
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    2021-08-31 snf701207

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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, createdBy=596833562866, createdName=楚秀娟, createdTime=Sun Dec 06 20:14:08 CST 2020, time=2020-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752295, encodeId=6ec01e522958c, content=<a href='/topic/show?id=28a915303ec' target=_blank style='color:#2F92EE;'>#REM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15303, encryptionId=28a915303ec, topicName=REM)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=78bc36479935, createdName=tongyongming, createdTime=Tue Apr 13 08:14:08 CST 2021, time=2021-04-13, status=1, ipAttribution=), 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createdName=lmm397, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1271087, encodeId=70b012e1087e4, content=<a href='/topic/show?id=4cfa14e8911' target=_blank style='color:#2F92EE;'>#PSA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14789, encryptionId=4cfa14e8911, topicName=PSA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=524d95, createdName=zhaozhouchifen, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302689, encodeId=9e451302689d2, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1349868, encodeId=f636134986824, content=<a href='/topic/show?id=d8e783268f' target=_blank style='color:#2F92EE;'>#Guselkumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8326, encryptionId=d8e783268f, topicName=Guselkumab)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=)]
    2020-12-06 楚秀娟

    #活动性#

    0

  5. 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    2021-04-13 tongyongming

    #REM#

    0

  6. 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createdName=lmm397, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1271087, encodeId=70b012e1087e4, content=<a href='/topic/show?id=4cfa14e8911' target=_blank style='color:#2F92EE;'>#PSA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14789, encryptionId=4cfa14e8911, topicName=PSA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=524d95, createdName=zhaozhouchifen, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302689, encodeId=9e451302689d2, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1349868, encodeId=f636134986824, content=<a href='/topic/show?id=d8e783268f' target=_blank style='color:#2F92EE;'>#Guselkumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8326, encryptionId=d8e783268f, topicName=Guselkumab)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=)]
    2020-10-21 Luyuxie_9

    #tremfya#

    0

  7. 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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, createdBy=596833562866, createdName=楚秀娟, createdTime=Sun Dec 06 20:14:08 CST 2020, time=2020-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752295, encodeId=6ec01e522958c, content=<a href='/topic/show?id=28a915303ec' target=_blank style='color:#2F92EE;'>#REM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15303, encryptionId=28a915303ec, topicName=REM)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=78bc36479935, createdName=tongyongming, createdTime=Tue Apr 13 08:14:08 CST 2021, time=2021-04-13, status=1, ipAttribution=), 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createdName=lmm397, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1271087, encodeId=70b012e1087e4, content=<a href='/topic/show?id=4cfa14e8911' target=_blank style='color:#2F92EE;'>#PSA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14789, encryptionId=4cfa14e8911, topicName=PSA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=524d95, createdName=zhaozhouchifen, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302689, encodeId=9e451302689d2, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1349868, encodeId=f636134986824, content=<a href='/topic/show?id=d8e783268f' target=_blank style='color:#2F92EE;'>#Guselkumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8326, encryptionId=d8e783268f, topicName=Guselkumab)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=)]
    2020-10-21 lmm397

    #关节炎#

    0

  8. 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createdName=lmm397, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1271087, encodeId=70b012e1087e4, content=<a href='/topic/show?id=4cfa14e8911' target=_blank style='color:#2F92EE;'>#PSA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14789, encryptionId=4cfa14e8911, topicName=PSA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=524d95, createdName=zhaozhouchifen, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302689, encodeId=9e451302689d2, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1349868, encodeId=f636134986824, content=<a href='/topic/show?id=d8e783268f' target=_blank style='color:#2F92EE;'>#Guselkumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8326, encryptionId=d8e783268f, topicName=Guselkumab)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=)]
    2020-10-21 zhaozhouchifen

    #PSA#

    0

  9. 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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, createdBy=596833562866, createdName=楚秀娟, createdTime=Sun Dec 06 20:14:08 CST 2020, time=2020-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752295, encodeId=6ec01e522958c, content=<a href='/topic/show?id=28a915303ec' target=_blank style='color:#2F92EE;'>#REM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15303, encryptionId=28a915303ec, topicName=REM)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=78bc36479935, createdName=tongyongming, createdTime=Tue Apr 13 08:14:08 CST 2021, time=2021-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1256422, encodeId=88f21256422df, content=<a href='/topic/show?id=af4c1e797f8' target=_blank style='color:#2F92EE;'>#tremfya#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17797, encryptionId=af4c1e797f8, topicName=tremfya)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=754b42, createdName=Luyuxie_9, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1266244, encodeId=9b8312662444e, content=<a href='/topic/show?id=57a53011364' target=_blank style='color:#2F92EE;'>#关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30113, encryptionId=57a53011364, topicName=关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f90281, createdName=lmm397, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1271087, encodeId=70b012e1087e4, content=<a href='/topic/show?id=4cfa14e8911' target=_blank style='color:#2F92EE;'>#PSA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14789, encryptionId=4cfa14e8911, topicName=PSA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=524d95, createdName=zhaozhouchifen, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302689, encodeId=9e451302689d2, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1349868, encodeId=f636134986824, content=<a href='/topic/show?id=d8e783268f' target=_blank style='color:#2F92EE;'>#Guselkumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8326, encryptionId=d8e783268f, topicName=Guselkumab)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=)]
    2020-10-21 医生2394

    #CHMP#

    0

  10. 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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, createdBy=596833562866, createdName=楚秀娟, createdTime=Sun Dec 06 20:14:08 CST 2020, time=2020-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752295, encodeId=6ec01e522958c, content=<a href='/topic/show?id=28a915303ec' target=_blank style='color:#2F92EE;'>#REM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15303, encryptionId=28a915303ec, topicName=REM)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=78bc36479935, createdName=tongyongming, createdTime=Tue Apr 13 08:14:08 CST 2021, time=2021-04-13, status=1, ipAttribution=), 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encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1349868, encodeId=f636134986824, content=<a href='/topic/show?id=d8e783268f' target=_blank style='color:#2F92EE;'>#Guselkumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8326, encryptionId=d8e783268f, topicName=Guselkumab)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Wed Oct 21 01:14:08 CST 2020, time=2020-10-21, status=1, ipAttribution=)]
    2020-10-21 tamgche

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AbbVie近日公布了最新的IIIb期头对头研究数据,结果显示,SKYRIZI(risankizumab-rzaa)组银屑病患者皮肤清除率优于COSENTYX(secukinumab)组。

AAD 2020:UCB的bimekizumab在银屑病方面显示出优于Stelara的皮肤清除率

与安慰剂或强生公司的Stelara(ustekinumab)相比,IL-17F抑制剂(bimekizumab)治疗银屑病可实现更好的皮肤清除率。

Ann Rheum Dis: 西湖大学郑厚峰团队阐明银屑病型关节炎和骨质疏松的关系

他们研究发现,银屑病性关节炎(Psoriatic arthritis)患者与对照组相比,骨量明显减少,但这个关联关系并不由遗传因素决定,也就是不具有归因关系.

Semin Arthritis Rheu:银屑病关节炎的死亡率

年轻PsA患者的死亡风险升高。更好地控制合并症可以降低这种风险。

FDA和EMA已接受bimekizumab治疗银屑病的市场营销申请

美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)均已接受UCB制药公司的银屑病治疗药物bimekizumab的市场营销申请。

Ann Rheum Dis:银屑病、银屑病关节炎与骨质疏松症之间的关系

综上所述,PsA对骨质疏松的影响是继发性的(例如药物治疗),并不存在因果关系。

拓展阅读

Rheumatology:3个月血清药物水平与银屑病关节炎患者治疗反应的关系

PsA患者的治疗反应与血清药物水平密切相关。3个月时的较高SDL与良好的治疗反应相关,且SDL阈值可用于区分不同的反应者。

Rheumatology:全球范围内银屑病关节炎的流行率及其地区差异

银屑病关节炎在欧洲和北美的患病率较高,而亚洲和南美相对较低。

Clin Rheumatol:银屑病关节炎患者治疗反应相关的预测因素

银屑病关节炎患者男性性别、高基线CRP水平与较好的治疗反应相关,而较高的HAQ评分、DAPSA评分和TJC则与较差的反应相关。

Arthritis Res Ther:阿达木单抗转用托法替尼治疗银屑病关节炎的疗效和安全性

从阿达木单抗直接切换至托法替尼的银屑病关节炎患者在疗效和安全性方面与持续使用托法替尼的患者相当。

Rheumatology:JAK抑制剂Upadacitinib对银屑病关节炎患者附着点炎的疗效分析

UPA15对银屑病关节炎相关附着点炎的显著疗效,改善效果在治疗12周后即可显现,并在56周内持续维持。