Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Asian Patients With Moderate to Severe Psoriasis: Improvements in Patient-Reported Outcomes in a Randomized Trial

IF 2.7 3区医学 Q2 DERMATOLOGY

Journal of Dermatology Pub Date : 2025-07-17 DOI:10.1111/1346-8138.17834

Jianzhong Zhang, Yangfeng Ding, Ping Wang, Linfeng Li, Weili Pan, Yan Lu, Hao Cheng, Xian Jiang, Ji-Chen Ho, Shuping Guo, Seong Jun Seo, Linda Stein Gold, Andrew Blauvelt, Joe Zhuo, Yichen Zhong, Brandon Becker, Leona Liu, Subhashis Banerjee, Diamant Thaçi

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引用次数: 0

Abstract

POETYK PSO-3, a 52-week, double-blind, phase 3 study, evaluated the efficacy and safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in adult patients with moderate to severe plaque psoriasis in mainland China, Taiwan, and South Korea. Secondary and additional endpoints included improvement on two patient-reported outcome measures: the Psoriasis Symptoms and Signs Diary (PSSD) total score and the Dermatology Life Quality Index (DLQI). Patients were randomized 1:2 to placebo or deucravacitinib 6 mg once daily; at week 16, patients receiving placebo crossed over to receive deucravacitinib. PSSD and DLQI score changes from baseline and response rates for achieving meaningful within-patient change from baseline in PSSD total score (≥ 15 points) and DLQI of 0 or 1 (DLQI 0/1) were assessed over 52 weeks. In POETYK PSO-3, 74 patients were randomized to placebo and 146 patients to deucravacitinib. At week 16, mean (95% confidence interval [CI]) PSSD total score changes from baseline were −1.9 (−6.9, 3.1) and −28.8 (−32.6, −25.0) in patients receiving placebo and deucravacitinib, respectively. At both weeks 16 and 52, the response rate for ≥ 15-point meaningful change in PSSD total score (95% CI) was 73.3% (65.3, 80.3) in the group randomized to deucravacitinib. At week 16, mean (95% CI) DLQI changes from baseline were −1.7 (−3.1, −0.4) and −7.4 (−8.4, −6.4) in patients receiving placebo and deucravacitinib, respectively. In patients randomized to deucravacitinib, DLQI 0/1 response rates (95% CI) at weeks 16 and 52 were 36.4% (28.5, 44.4) and 44.7% (36.5, 52.9), respectively. Deucravacitinib was associated with meaningful and sustained improvements in psoriasis symptoms and signs and in quality of life in Asian patients with moderate to severe plaque psoriasis.

Trial Registration: ClinicalTrials.gov identifier: NCT04167462

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Deucravacitinib，一种口服选择性变steric酪氨酸激酶2抑制剂，用于亚洲中重度牛皮癣患者：一项随机试验中患者报告结果的改善

POETYK PSO-3是一项为期52周的双盲iii期研究，评估了口服选择性变质酪氨酸激酶2抑制剂deucravacitinib对中国大陆、台湾和韩国中度至重度斑块型银屑病成人患者的疗效和安全性。次要和额外的终点包括两项患者报告的结果测量的改善：牛皮癣症状和体征日记（PSSD）总分和皮肤病生活质量指数（DLQI）。患者按1:2随机分为安慰剂组或deucravacitinib组（6 mg，每日1次）；在第16周，接受安慰剂的患者交叉接受deucravacitinib。在52周内评估PSSD和DLQI评分较基线的变化，以及PSSD总分（≥15分）和DLQI为0或1 （DLQI 0/1）较基线实现有意义的患者内变化的缓解率。在POETYK PSO-3中，74名患者随机分配到安慰剂组，146名患者随机分配到deucravacitinib组。在第16周，接受安慰剂和deucravacitinib治疗的患者PSSD总分与基线相比的平均（95%置信区间[CI]）变化分别为-1.9（-6.9,3.1）和-28.8（-32.6,-25.0）。在第16周和第52周，随机分配到deucravacitinib组的PSSD总分≥15点有意义变化的缓解率（95% CI）为73.3%（65.3,80.3）。在第16周，接受安慰剂和deucravacitinib治疗的患者DLQI较基线的平均（95% CI）变化分别为-1.7（-3.1,-0.4）和-7.4（-8.4,-6.4）。在随机分配到deucravacitinib的患者中，DLQI 0/1缓解率（95% CI）在第16周和第52周分别为36.4%（28.5,44.4）和44.7%（36.5,52.9）。Deucravacitinib与亚洲中度至重度斑块型银屑病患者的银屑病症状和体征以及生活质量有意义和持续的改善相关。试验注册：ClinicalTrials.gov标识符：NCT04167462。

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来源期刊

Journal of Dermatology 医学-皮肤病学

CiteScore

4.60

自引率

9.70%

发文量

368

审稿时长

4-8 weeks

期刊介绍： The Journal of Dermatology is the official peer-reviewed publication of the Japanese Dermatological Association and the Asian Dermatological Association. The journal aims to provide a forum for the exchange of information about new and significant research in dermatology and to promote the discipline of dermatology in Japan and throughout the world. Research articles are supplemented by reviews, theoretical articles, special features, commentaries, book reviews and proceedings of workshops and conferences. Preliminary or short reports and letters to the editor of two printed pages or less will be published as soon as possible. Papers in all fields of dermatology will be considered.