Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial

医学 强直性脊柱炎 安慰剂 禁忌症 内科学 脊柱炎 临床终点 不利影响 临床试验 外科 病理 替代医学
作者
Désirée van der Heijde,In-Ho Song,Aileen L. Pangan,Atul Deodhar,Filip Van den Bosch,Walter P. Maksymowych,Tae‐Hwan Kim,Mitsumasa Kishimoto,Andrea Everding,Yunxia Sui,Xin Wang,Alvina D. Chu,Joachim Sieper
出处
期刊:The Lancet [Elsevier BV]
卷期号:394 (10214): 2108-2117 被引量:295
标识
DOI:10.1016/s0140-6736(19)32534-6
摘要

The JAK pathway is a potential therapeutic target in ankylosing spondylitis. This study assessed the efficacy and safety of upadacitinib, a selective JAK1 inhibitor, in patients with ankylosing spondylitis.This multicentre, randomised, double-blind, placebo-controlled, two-period, parallel-group, phase 2/3 study, SELECT-AXIS 1, enrolled adults in 62 sites in 20 countries. Eligible patients had active ankylosing spondylitis, fulfilled modified New York criteria, were previously untreated with biological disease-modifying antirheumatic drugs, and had inadequate response to at least two or intolerance or contraindication to non-steroidal anti-inflammatory drugs. Patients were randomly assigned 1:1 using interactive response technology to take oral upadacitinib 15 mg once daily or oral placebo for the 14-week period 1; only period 1 data are reported here. The primary endpoint was the composite outcome measure of the Assessment of SpondyloArthritis international Society 40 response at week 14. Analyses were done in the full analysis set of patients who were randomly assigned and received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT03178487.Between Nov 30, 2017, and Oct 15, 2018, 187 patients were randomly assigned to upadacitinib 15 mg (93 patients) or to placebo (94 patients), and 178 (95%) patients (89 in the upadacitinib group and 89 in the placebo group) completed period 1 on study drug (by the completion date of Jan 21, 2019). Significantly more patients had an Assessment of SpondyloArthritis international Society 40 response in the upadacitinib group versus in the placebo group at week 14 (48 [52%] of 93 patients vs 24 [26%] of 94 patients; p=0·0003; treatment difference 26% [95% CI 13-40]). Adverse events were reported in 58 (62%) of 93 patients in the upadacitinib group versus 52 (55%) of 94 in the placebo group. The most common adverse event in the upadacitinib group was increased creatine phosphokinase (eight [9%] of 93 patients in the upadacitinib group vs two [2%] of 94 patients with placebo). No serious infections, herpes zoster, malignancy, venous thromboembolic events, or deaths were reported; one serious adverse event was reported in each group.Upadacitinib 15 mg was efficacious and well tolerated in patients with active ankylosing spondylitis who had an inadequate response or contraindication to non-steroidal anti-inflammatory drugs. These data support the further investigation of upadacitinib for the treatment of axial spondyloarthritis.AbbVie.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
大神完成签到,获得积分0
刚刚
Avert.完成签到 ,获得积分10
1秒前
君回应助wen采纳,获得10
1秒前
以舟完成签到,获得积分10
2秒前
樱悼柳雪发布了新的文献求助10
2秒前
莉莉完成签到,获得积分10
2秒前
Singularity应助啊伟采纳,获得10
2秒前
ED应助烂漫臻采纳,获得10
3秒前
3秒前
3秒前
超A完成签到,获得积分20
3秒前
clair发布了新的文献求助20
3秒前
Singularity举报酷酷的赛凤求助涉嫌违规
4秒前
扶苏发布了新的文献求助10
4秒前
黄杰发布了新的文献求助10
5秒前
偷喝汽水发布了新的文献求助10
5秒前
5秒前
深情安青应助cx330采纳,获得10
5秒前
饼干完成签到,获得积分10
5秒前
Lee完成签到,获得积分10
5秒前
233完成签到,获得积分10
6秒前
丘比特应助揽星色采纳,获得10
6秒前
与山发布了新的文献求助10
7秒前
IMF完成签到 ,获得积分10
7秒前
7秒前
Condor完成签到,获得积分10
8秒前
沅芷0871发布了新的文献求助10
8秒前
莉莉发布了新的文献求助10
8秒前
Jasper应助执着的忆雪采纳,获得10
8秒前
8秒前
科研通AI5应助kk采纳,获得10
9秒前
9秒前
雪糕刺客完成签到,获得积分20
9秒前
9秒前
WANGCHU发布了新的文献求助10
9秒前
9秒前
赘婿应助完美芒果采纳,获得10
10秒前
stuckinrain完成签到,获得积分10
10秒前
11秒前
我是老大应助俊汝燕采纳,获得30
11秒前
高分求助中
Picture Books with Same-sex Parented Families: Unintentional Censorship 700
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Nucleophilic substitution in azasydnone-modified dinitroanisoles 500
不知道标题是什么 500
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
Effective Learning and Mental Wellbeing 300
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3974426
求助须知:如何正确求助?哪些是违规求助? 3518788
关于积分的说明 11195842
捐赠科研通 3254946
什么是DOI,文献DOI怎么找? 1797649
邀请新用户注册赠送积分活动 877037
科研通“疑难数据库(出版商)”最低求助积分说明 806130