Abatacept for rheumatoid arthritis refractory to tumor necrosis factor α inhibition
Abatacept for rheumatoid arthritis refractory to tumor necrosis factor α inhibition
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DOI：
10.1056/nejmoa050524
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发表时间：
2005-09-15
影响因子：
158.5
通讯作者：
Dougados, M
中科院分区：
文献类型：
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作者：
Genovese, MC;Becker, J;Dougados, M
背景：相当数量的类风湿关节炎患者对肿瘤坏死因子α（TNF-α）抑制剂的反应不充分或不持续。我们进行了一项随机、双盲、3期临床试验，以评估阿巴西普（一种选择性共刺激调节剂）在活动性类风湿关节炎和对抗TNF-α治疗反应不充分的患者中的疗效和安全性。在第1、15和29天以及此后每28天接受阿巴西普或安慰剂6个月，以及至少一种缓解疾病的抗风湿药。患者在随机化前停止抗TNF-α治疗。评估了美国流变学学会（ACR）20次应答率（表明临床改善20%或更高）和功能障碍改善率，如健康评估问卷（HAQ）残疾指数评分所反映。结果：6个月后，阿巴西普组ACR 20次应答率为50.4%，安慰剂组为19.5%（P
BACKGROUND:A substantial number of patients with rheumatoid arthritis have an inadequate or unsustained response to tumor necrosis factor alpha (TNF-alpha) inhibitors. We conducted a randomized, double-blind, phase 3 trial to evaluate the efficacy and safety of abatacept, a selective costimulation modulator, in patients with active rheumatoid arthritis and an inadequate response to at least three months of anti-TNF-alpha therapy.METHODS:Patients with active rheumatoid arthritis and an inadequate response to anti-TNF-alpha therapy were randomly assigned in a 2:1 ratio to receive abatacept or placebo on days 1, 15, and 29 and every 28 days thereafter for 6 months, in addition to at least one disease-modifying antirheumatic drug. Patients discontinued anti-TNF-alpha therapy before randomization. The rates of American College of Rheumatology (ACR) 20 responses (indicating a clinical improvement of 20 percent or greater) and improvement in functional disability, as reflected by scores for the Health Assessment Questionnaire (HAQ) disability index, were assessed.RESULTS:After six months, the rates of ACR 20 responses were 50.4 percent in the abatacept group and 19.5 percent in the placebo group (P