Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double-Blind, Randomized Controlled Trial
Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double-Blind, Randomized Controlled Trial
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DOI：
10.1002/art.41032
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发表时间：
2019-08-28
影响因子：
13.3
通讯作者：
Genovese, Mark C.
中科院分区：
文献类型：
--
作者：
Fleischmann, Roy;Pangan, Aileen L.;Genovese, Mark C.
目的 评估与安慰剂或阿达木单抗相比，乌帕替尼（一种 JAK1 选择性抑制剂）对甲氨蝶呤（MTX）反应不足的类风湿性关节炎（RA）患者的疗效，包括抑制放射学进展的能力和安全性。方法 总计 1,629 名对 MTX 反应不足的 RA 患者被随机（2:2:1）接受 upadacitinib（15 mg，每天一次）、安慰剂或阿达木单抗（40 mg，每隔一周），同时继续服用稳定背景剂量的 MTX。主要终点是美国风湿病学会 20% (ACR20) 改善反应以及 28 个关节的疾病活动评分，使用 C 反应蛋白水平 (DAS28-CRP)
Objective To evaluate the efficacy, including capacity for inhibition of radiographic progression, and safety of upadacitinib, a JAK1-selective inhibitor, as compared to placebo or adalimumab in patients with rheumatoid arthritis (RA) who have experienced an inadequate response to methotrexate (MTX). Methods In total, 1,629 RA patients with an inadequate response to MTX were randomized (2:2:1) to receive upadacitinib (15 mg once daily), placebo, or adalimumab (40 mg every other week) while continuing to take a stable background dose of MTX. The primary end points were achievement of an American College of Rheumatology 20% (ACR20) improvement response and a Disease Activity Score in 28 joints using C-reactive protein level (DAS28-CRP) of