Lancet:Guselkumab用于活动性银屑病性关节炎

2020-03-16 MedSci原创 MedSci原创

Guselkumab可有效治疗对肿瘤坏死因子抑制剂反应不足的银屑病关节炎

许多银屑病关节炎患者对肿瘤坏死因子(TNF)抑制剂反应不足。Guselkumab是一种白介素-23(IL-23)特异性抑制剂,在II期试验中显著改善了银屑病关节炎的症状和体征。近日研究人员公布了其III期临床研究结果。

本次研究在13个国家,86个临床中心开展。活动性银屑病性关节炎患者参与研究,患者至少存在三个肿胀和三个疼痛的的关节,C-反应蛋白≥0.3 mg/dL,且接受至少4个月的阿普斯特,至少3个月的非生物性疾病修饰性抗风湿药(DMARDs)或至少4周的非甾体抗炎药物。约30%的研究参与者以前可能接受过1-2种TNF抑制剂。患者随机接受每4周100mg Guselkumab、在第0、4周注射100mg Guselkumab 1,随后每8周一次或的安慰剂。研究的主要终点为24周美国风湿病学会疾病症状改善至少20% (ACR20)的患者比例。

381名患者参与研究,其中每4周服用一次Guselkumab组128人,每8周服用一次Guselkumab组127人,安慰剂组126人。362名患者完成24周治疗。与安慰剂组(66/127)相比,每4周1次Guselkumab治疗组(76/128)和每8周治疗组(66/127)患者达到ACR20比例显著增加,与安慰剂相比,每4周治疗组差异为37%,每8周组为30%。24周时,Guselkumab每4周治疗组没有发生严重不良事件,每8周组4名患者、安慰剂组5名患者发生严重不良事件。安慰剂组的1名患者死于心力衰竭,2名患者出现严重感染;Guselkumab治疗组没有死亡或严重感染事件。

研究认为,Guselkumab可有效治疗对肿瘤坏死因子抑制剂反应不足的银屑病关节炎。

原始出处:

Prof Atul Deodhar et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. March 13, 2020.

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    2020-05-30 howi
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    2021-01-20 snf701207
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    2020-03-18 lmm397
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    2020-03-16 wxl882001

    学习一下

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