『柳叶刀』(Lancet)上的一项临床研究结果显示,与安慰剂相比,Ustekinumab能够明显改善活动性银屑病关节炎,其有望成为治疗该病的新生物制剂。 这项3期多中心、双盲、安慰剂对照研究在欧洲、北美和亚太的104家研究中心开展。纳入活动性银屑病关节炎患者,随机分配接受45mg ustekinumab, 90mg ustekinumab或安慰剂治疗。 结果,于2009年至2011年,共纳入615例患者。研究显示,24周时,45mg治疗组和90mg治疗组分别有42.4%和49.5%的患者获得ACR20(美国风湿病学会评分)改善,而对照组只有22.8%。且治疗52周后疗效仍维持。 第16周,治疗组和安慰剂组出现不良事件的患者比例很类似,分别为41.8%和42.0%。 Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial Summary Background Many patients with psoriasis develop psoriatic arthritis, a chronic inflammatory disease that afflicts peripheral synovial, axial, and entheseal structures. The fully human monoclonal antibody ustekinumab is an efficacious treatment for moderate-to-severe plaque psoriasis. We did a randomised, placebo-controlled, phase 3 trial to assess the safety and efficacy of ustekinumab in patients with active psoriatic arthritis. Methods In this phase 3, multicentre, double-bli
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