Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial
Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial
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DOI：
10.1016/s0140-6736(15)61134-5
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发表时间：
2015-09-19
期刊：
影响因子：
168.9
通讯作者：
Mpofu, Shephard
中科院分区：
文献类型：
--
作者：
McInnes, Iain B.;Mease, Philip J.;Mpofu, Shephard
背景白细胞介素17 A是一种促炎细胞因子，参与银屑病关节炎的发病机制。我们评估了皮下注射人抗白细胞介素-17A单克隆抗体Rakkinumab治疗银屑病关节炎患者的疗效和安全性。方法在这项3期、双盲、安慰剂对照研究中，在亚洲、澳大利亚、加拿大、欧洲和美国的76个中心进行，年龄>= 18岁的活动性银屑病关节炎患者随机分为1：1：1：1个比率，计算机生成的区组，接受皮下安慰剂或阿基诺单抗300 mg、150 mg、或75 mg，从基线开始每周一次，然后从第4周开始每4周一次。患者和研究者对治疗分配设盲。主要终点是第24周时达到美国流变学会反应标准（ACR 20）至少20%改善的患者比例。研究结果在2013年4月14日至11月25日期间，397名患者被随机分配接受300 mg（n=100），150 mg（n = 100），75 mg（n=99）或安慰剂（n=98）。ClinicalTrials.gov在第24周时，接受300 mg克林单抗治疗的患者中达到ACR 20的比例显著更高（54例[54%]患者;与安慰剂相比的比值比为6.81，95% CI 3.42-13.56; p
Background Interleukin 17A is a proinflammatory cytokine that is implicated in the pathogenesis of psoriatic arthritis. We assessed the efficacy and safety of subcutaneous secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis.Methods In this phase 3, double-blind, placebo-controlled study undertaken at 76 centres in Asia, Australia, Canada, Europe, and the USA, adults (aged >= 18 years old) with active psoriatic arthritis were randomly allocated in a 1: 1: 1: 1 ratio with computer-generated blocks to receive subcutaneous placebo or secukinumab 300 mg, 150 mg, or 75 mg once a week from baseline and then every 4 weeks from week 4. Patients and investigators were masked to treatment assignment. The primary endpoint was the proportion of patients achieving at least 20% improvement in the American College of Rheumatology response criteria (ACR20) at week 24. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01752634.Findings Between April 14, and Nov 25, 2013, 397 patients were randomly assigned to receive secukinumab 300 mg (n=100), 150 mg (n=100), 75 mg (n=99), or placebo (n=98). A significantly higher proportion of patients achieved an ACR20 at week 24 with secukinumab 300 mg (54 [54%] patients; odds ratio versus placebo 6.81, 95% CI 3.42-13.56; p