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
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
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DOI：
10.1016/s0140-6736(13)60594-2
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发表时间：
2013-08-31
期刊：
影响因子：
168.9
通讯作者：
Doyle, Mittie K.
中科院分区：
文献类型：
--
作者：
McInnes, Iain B.;Kavanaugh, Arthur;Doyle, Mittie K.
背景：许多银屑病患者发生银屑病关节炎，这是一种慢性炎症性疾病，累及周围滑膜、轴突和末端结构。全人单抗Ustekinumab是治疗中重度斑块型银屑病的有效药物。我们进行了一项随机的、安慰剂对照的第三阶段试验，以评估ustekinumab对活动期银屑病关节炎患者的安全性和有效性。方法在第三阶段，在欧洲、北美和亚太地区的104个地点进行的多中心、双盲、安慰剂对照试验，患有活动期银屑病关节炎的成年人(5次疼痛和5次关节肿胀，C反应蛋白和GT；=3.0 mg/L)在0周、4周和此后每12周随机分配(1：1：1，基于交互式语音-网络响应系统实现的算法的动态中心随机化)45 mg ustekinumab、90 mg ustekinumab或安慰剂。在第16周，关节压痛和肿胀都改善不到5%的患者进入隐蔽的早期逃逸，并接受45 mg Ustekinumab(如果是安慰剂组)或90 mg Ustekinumab(如果是45 mg组)。在第24周，安慰剂组的所有其余患者服用Ustekinumab 45 mg，他们在第28周继续服用，此后每12周继续服用一次。我们的主要终点是在第24周时美国风湿病学会(ACR20)标准改善20%或更多。这项试验在ClinicalTrials.gov(NCT01009086)和EudraCT(2009-012264-14)注册。结果在2009年11月30日至2011年3月30日期间，615名患者被随机分配-206mgustekinumab，205mgustekinumab，204mgustekinumab，204mgustekinumab。接受Ustekinumab治疗的患者(45 mg组205人中87人[42.4%]，90 mg组204人中101人[49.5%])比安慰剂组(206人中47人[22.8%])在24周时达到ACR20(p
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-blind, placebo-controlled trial at 104 sites in Europe, North America, and Asia-Pacific, adults with active psoriatic arthritis (>= 5 tender and >= 5 swollen joints, C-reactive protein >= 3.0 mg/L) were randomly assigned (1:1:1, by dynamic central randomisation based on an algorithm implemented by an interactive voice-web response system) to 45 mg ustekinumab, 90 mg ustekinumab, or placebo at week 0, week 4, and every 12 weeks thereafter. At week 16, patients with less than 5% improvement in both tender and swollen joint counts entered masked early-escape and were given 45 mg ustekinumab (if in the placebo group) or 90 mg ustekinumab (if in the 45 mg group). At week 24, all remaining patients in the placebo group received ustekinumab 45 mg, which they continued at week 28 and every 12 weeks thereafter. Our primary endpoint was 20% or greater improvement in American College of Rheumatology (ACR20) criteria at week 24. This trial is registered with ClinicalTrials.gov (NCT01009086) and EudraCT (2009-012264-14).Findings Between Nov 30, 2009, and March 30, 2011, 615 patients were randomly assigned-206 to placebo, 205 to 45 mg ustekinumab, and 204 to 90 mg ustekinumab. More ustekinumab-treated (87 of 205 [42.4%] in the 45 mg group and 101 of 204 [49.5%] in the 90 mg group) than placebo-treated (47 of 206 [22.8%]) patients achieved ACR20 at week 24 (p