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

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    2021-08-31 snf701207
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encryptionId=9a1b1e7916c, topicName=TREM)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/4E6244DB7C1860858424437821E08291/100, createdBy=a6a52500039, createdName=ms3994565386320060, createdTime=Sat Nov 21 14:14:08 CST 2020, time=2020-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912460, encodeId=2f26191246099, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Tue Aug 31 17:14:08 CST 2021, time=2021-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1724011, encodeId=85581e2401130, content=<a href='/topic/show?id=2d996516e7c' target=_blank style='color:#2F92EE;'>#活动性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, 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=27, 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=27, 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=31, 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=47, 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=38, 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=46, 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=)]
  5. 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target=_blank style='color:#2F92EE;'>#活动性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, 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=27, 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=47, 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=38, 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=46, 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=)]
    2021-04-13 tongyongming
  6. 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target=_blank style='color:#2F92EE;'>#活动性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, 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=27, 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=47, 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=38, 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=46, 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
  7. 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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=47, 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=38, 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=46, 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
  8. 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  9. 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    2020-10-21 医生2394
  10. 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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

Arthritis Rheumatol:探索性别差异:女性银屑病关节炎患者对TNFi治疗反应的深入分析

在接受首次TNFi治疗的银屑病关节炎患者中,女性相比男性在治疗反应和药物持续使用上表现出较低的成功率。

Arthritis Res Ther:生物制剂和靶向合成DMARDs治疗是否会改善银屑病关节炎患者的工作生产力?

银屑病关节炎(PsA)是一种慢性炎症性疾病,不仅影响患者的健康状态,还严重影响其工作能力和休闲活动的参与。生物制剂(bDMARDs)和靶向合成疾病修饰性抗风湿药物(tsDMARDs)作为治疗PsA的新

3期临床研究揭秘!upadacitinib助力中轴型银屑病关节炎患者

upadacitinib治疗银屑病关节炎中轴受累患者疗效显著

Rheumatology:Bimekizumab显著改善银屑病关节炎患者的症状!

bimekizumab为PsA患者提供了长期的疾病缓解和改善生活质量的效果。

Rheumatology:瑞莎珠单抗治疗银屑病关节炎——疗效显著且耐受性良好!

在对csDMARD-IR的活动性PsA患者中,持续的risankizumab治疗展现出强大的长期疗效

Bimekizumab 治疗活动性银屑病关节炎患者的疗效与安全性 (BE COMPLETE研究)

对TNFα抑制剂反应不足或不耐受的活动性银屑病关节炎患者,Bimekizumab治疗相比安慰剂在第16周的关节和皮肤疗效结果上显示出优越性。