501 - Efficacy and safety of upadacitinib in a phase 2 randomized, double-blind, dose-ranging study of adults with extensive non-segmental vitiligo

剂量范围研究 白癜风 医学 双盲 测距 随机对照试验 外科 皮肤病科 病理 地理 大地测量学 替代医学 安慰剂
作者
Thierry Passeron,Khaled Ezzedine,Iltefat Hamzavi,Nanja van Geel,Bethanee J. Schlosser,Xiaofei Hu,Xiaohong Huang,David Rosmarin,John E. Harris,Heidi S. Camp,Amit G. Pandya
出处
期刊:British Journal of Dermatology [Oxford University Press]
卷期号:190 (Supplement_2): ii65-ii66 被引量:2
标识
DOI:10.1093/bjd/ljad498.066
摘要

Abstract Introduction & Objectives Janus kinase (JAK) inhibition is a promising approach for the treatment of vitiligo. Here, we report the clinical efficacy and safety of upadacitinib (UPA), an oral JAK inhibitor, in a phase 2b multicenter, randomized, double-blind, placebo-controlled study of adults with extensive non-segmental vitiligo (NSV). Materials & Methods Eligible patients were aged 18–65 years with NSV, a Facial Vitiligo Area Scoring Index (F-VASI) of ≥0.5, and a Total Vitiligo Area Scoring Index (T-VASI) of ≥5 at baseline. This 52-week study (NCT04927975) comprised 2 periods. In period 1, patients were randomly assigned to once daily UPA 22 mg (UPA22), UPA 11 mg (UPA11), UPA 6 mg (UPA6), or placebo (PBO) for 24 weeks of treatment. In a 28-week blinded extension (period 2), patients receiving UPA during period 1 continued their respective regimens; patients who received PBO in period 1 were pre-assigned to either UPA11 or UPA22. Clinical efficacy endpoints evaluated through week 36 included percent change from baseline (%CFB) in F-VASI (week 24, primary endpoint), reductions from baseline in F-VASI of ≥50% (F-VASI 50) and ≥75% (F-VASI 75), %CFB in T-VASI, and reduction from baseline in T-VASI of ≥50% (T-VASI 50). Safety data as of January 13, 2023 (data cutoff date) are presented. Results Of the 185 patients enrolled in period 1, 165 (89.2%) continued to period 2. At baseline, 68% of patients had extensive vitiligo (T-VASI > 10), and 71% had active vitiligo. At week 24, the %CFB in F-VASI was greater with UPA11 (−35.6%) and UPA22 (−34.0%) vs PBO (−14.4%; nominal P = .005 and P = .013, respectively). A greater proportion of patients achieved F-VASI 50 and F-VASI 75 with UPA11 (38.3%, 19.1%) and UPA22 (39.5%, 14.0%) vs PBO (10.9%, 2.2%; nominal P < .05 for both doses and for both endpoints). Likewise, the %CFB in T-VASI was greater with UPA11 (−17.3%) and UPA22 (−20.7%) vs PBO (−6.4%; nominal P = .026 and P = .005, respectively). A higher percentage of patients achieved T-VASI 50 with UPA22 (11.6%) than with PBO (2.2%; nominal P = .027). UPA efficacy continued to improve through week 36, with %CFB in F-VASI for UPA6, UPA11, and UPA22 of −20.8%, −44.9% and −47.7%, respectively. At week 36, F-VASI 50 was achieved with UPA6, UPA11, and UPA22 by 34.2%, 54.3% and 61.5% of patients and F-VASI 75 by 15.8%, 40.0%, and 30.8%, respectively. At week 36, %CFB in T-VASI for UPA6, UPA11 and UPA22 were −24.3%, −32.0% and −37.6%, with 10.5%, 20.0% and 19.2% of patients, respectively, achieving T-VASI 50. Treatment-emergent adverse event (TEAE) rates were generally similar with UPA and PBO in period 1 (most common TEAEs: COVID-19, acne, fatigue, and headache) and were similar across treatment arms in period 2. One death adjudicated as undetermined/unknown cause and deemed by the investigator to have no reasonable possibility of being related to study drug occurred in the UPA22 group (period 1). One adjudicated event of nonfatal ischemic stroke occurred with UPA11 (period 2). There were no adjudicated events of venous thromboembolism, gastrointestinal perforation, or events of opportunistic infection, active tuberculosis, or malignancy. Conclusion Treatment with UPA for 24 weeks resulted in greater improvements vs PBO in the clinical outcomes of adults with extensive NSV. Observed clinical efficacy continued to improve through week 36 with UPA treatment. UPA was generally well tolerated, with no new safety signals ­identified.
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
玉玲子LIN发布了新的文献求助10
刚刚
在水一方应助汤飞柏采纳,获得10
刚刚
whatever应助追寻航空采纳,获得10
刚刚
_Charmo发布了新的文献求助10
1秒前
Echo完成签到,获得积分10
1秒前
科目三应助芒草lx采纳,获得10
1秒前
量子星尘发布了新的文献求助10
1秒前
Ava应助小晚采纳,获得10
2秒前
ding应助小晚采纳,获得10
2秒前
灵巧灵槐完成签到,获得积分10
4秒前
4秒前
任夏发布了新的文献求助10
4秒前
5秒前
香蕉觅云应助狐狐采纳,获得10
5秒前
gugugaga发布了新的文献求助10
5秒前
杨佳睿完成签到 ,获得积分10
6秒前
CodeCraft应助学习采纳,获得10
6秒前
文静不斜完成签到,获得积分20
6秒前
zpctx发布了新的文献求助10
6秒前
爆米花应助pp采纳,获得10
6秒前
慕青应助Delia采纳,获得10
6秒前
chanchanman发布了新的文献求助20
6秒前
7秒前
小鱼发布了新的文献求助10
8秒前
8秒前
陈明娃完成签到,获得积分10
9秒前
9秒前
jessie完成签到,获得积分10
10秒前
不羁的风完成签到,获得积分10
11秒前
小鱼发布了新的文献求助30
11秒前
11秒前
11秒前
12秒前
里里完成签到,获得积分10
12秒前
12秒前
JXHX完成签到 ,获得积分10
14秒前
吕邓宏发布了新的文献求助10
15秒前
16秒前
_Charmo完成签到,获得积分10
16秒前
16秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Picture Books with Same-sex Parented Families: Unintentional Censorship 500
Nucleophilic substitution in azasydnone-modified dinitroanisoles 500
不知道标题是什么 500
A Preliminary Study on Correlation Between Independent Components of Facial Thermal Images and Subjective Assessment of Chronic Stress 500
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 360
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 3971091
求助须知:如何正确求助?哪些是违规求助? 3515797
关于积分的说明 11179488
捐赠科研通 3250872
什么是DOI,文献DOI怎么找? 1795536
邀请新用户注册赠送积分活动 875891
科研通“疑难数据库(出版商)”最低求助积分说明 805207