Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis
Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis
复制标题
DOI：
10.1056/nejmoa2008250
复制
发表时间：
2020-10-15
影响因子：
158.5
通讯作者：
Xavier, Ricardo M.
中科院分区：
文献类型：
--
作者：
Rubbert-Roth, Andrea;Enejosa, Jeffrey;Xavier, Ricardo M.
研究背景Upadacitinib是一种口服选择性Janus激酶抑制剂，用于治疗类风湿关节炎。在这项为期24周的3期双盲对照试验中，我们以1：1的比例随机将患者分为两组，分别给予口服Upadacitinib(15 mg，每日1次)或静脉注射阿帕替尼(15 mg，每日1次)，与T细胞共刺激调节剂abatacept相比，其疗效和安全性尚不清楚。主要终点是根据第12周的C-反应蛋白水平(DAS28-CRP；范围从0到9.4，分数越高表明疾病活动越多)对28个关节的综合疾病活动评分与基线的变化，以进行非劣势评估。在12周时，关键的次要终点是服用upadacitinib的患者在DAS28-CRP较基线的变化以及DAS28-CRP小于2.6的临床缓解率方面优于阿巴替尼。在12周时，upadacitinib组和abatacept组的基线DAS28-CRP值分别为5.70和5.88，平均变化分别为-2.52和-2.00(差异，-0.52分；95%可信区间[CI]，-0.69至-0.35；P
BackgroundUpadacitinib is an oral selective Janus kinase inhibitor to treat rheumatoid arthritis. The efficacy and safety of upadacitinib as compared with abatacept, a T-cell costimulation modulator, in patients with rheumatoid arthritis refractory to biologic disease-modifying antirheumatic drugs (DMARDs) are unclear.MethodsIn this 24-week, phase 3, double-blind, controlled trial, we randomly assigned patients in a 1:1 ratio to receive oral upadacitinib (15 mg once daily) or intravenous abatacept, each in combination with stable synthetic DMARDs. The primary end point was the change from baseline in the composite Disease Activity Score for 28 joints based on the C-reactive protein level (DAS28-CRP; range, 0 to 9.4, with higher scores indicating more disease activity) at week 12, assessed for noninferiority. Key secondary end points at week 12 were the superiority of upadacitinib over abatacept in the change from baseline in the DAS28-CRP and the percentage of patients having clinical remission according to a DAS28-CRP of less than 2.6.ResultsA total of 303 patients received upadacitinib, and 309 patients received abatacept. From baseline DAS28-CRP values of 5.70 in the upadacitinib group and 5.88 in the abatacept group, the mean change at week 12 was -2.52 and -2.00, respectively (difference, -0.52 points; 95% confidence interval [CI], -0.69 to -0.35; P