Deucravacitinib治疗日本斑块、广泛性脓疱或红皮病型银屑病患者:POETYK PSO-4研究中患者报告的结果

IF 2.9 3区 医学 Q2 DERMATOLOGY Journal of Dermatology Pub Date : 2024-12-06 DOI:10.1111/1346-8138.17570
Yayoi Tada, April W. Armstrong, Shinichi Imafuku, Yukari Okubo, Akimichi Morita, Yichen Zhong, Joe Zhuo, Brandon Becker, Andrew Napoli, Subhashis Banerjee, Mamitaro Ohtsuki
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引用次数: 0

摘要

Deucravacitinib是一种口服、选择性、变steric酪氨酸激酶2抑制剂,在日本被批准用于斑块、广泛性脓疱或红皮病型银屑病的成年患者。POETYK PSO-4 (NCT03924427)是一项开放标签,单组,3期试验,显示deucravacitinib对日本斑块(n = 63),广泛性脓疱(n = 3)或红皮病(n = 8)牛皮癣患者有效且耐受性良好。POETYK PSO-4的其他终点包括通过患者报告的结果测量银屑病症状和体征日记和皮肤病生活质量指数测量的变化。在52周内,对每组患者进行每项测量的评分与基线的平均变化和达到皮肤病学生活质量指数得分0或1的反应率进行评估。所有的评估报告都是观察到的,没有归咎,在治疗人群中。每组均报告第16周患者报告的两项结果指标较基线评分有所改善,在第52周维持或数字上有所改善。在第52周,每组中大约三分之二的患者达到皮肤病生活质量指数得分0或1,表明疾病对生活质量没有影响。这些结果表明,在日本斑块、广泛性脓疱或红皮病型银屑病患者中,deucravacitinib治疗可改善银屑病症状和体征以及生活质量。广泛性脓疱性或红皮病性牛皮癣患者的少数限制了这些组中发现的普遍可解释性。
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Deucravacitinib in Japanese patients with plaque, generalized pustular, or erythrodermic psoriasis: Patient-reported outcomes in the POETYK PSO-4 study

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in Japan for adult patients with plaque, generalized pustular, or erythrodermic psoriasis. POETYK PSO-4 (NCT03924427), an open-label, single-arm, phase 3 trial, showed that deucravacitinib was effective and well tolerated in Japanese patients with plaque (n = 63), generalized pustular (n = 3), or erythrodermic (n = 8) psoriasis. Additional end points in POETYK PSO-4 included change measured by the patient-reported outcome measures Psoriasis Symptoms and Signs Diary and Dermatology Life Quality Index. Mean changes from baseline in score on each measure and the response rate for achieving Dermatology Life Quality Index scores of 0 or 1 were assessed in each patient group over 52 weeks. All assessments were reported as observed, without imputation, in the as-treated population. Each group reported week 16 score improvements from baseline for both patient-reported outcome measures that were maintained or numerically improved at week 52. At week 52, approximately two-thirds of patients in each group achieved a Dermatology Life Quality Index score of 0 or 1, indicating no impact of disease on quality of life. These results demonstrate improvements in psoriasis symptoms and signs and in quality of life with deucravacitinib treatment in Japanese patients with plaque, generalized pustular, or erythrodermic psoriasis. The small number of patients with generalized pustular or erythrodermic psoriasis limits the generalized interpretability of the findings in these groups.

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来源期刊
Journal of Dermatology
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.
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