Deucravacitinib 可改善中度至重度银屑病患者的疗效:POETYK PSO-1 和 PSO-2 3 期随机试验结果。

IF 3.5 3区 医学 Q1 DERMATOLOGY
Dermatology and Therapy Pub Date : 2024-08-01 Epub Date: 2024-07-30 DOI:10.1007/s13555-024-01224-x
April W Armstrong, Matthias Augustin, Jennifer L Beaumont, Tan P Pham, Stacie Hudgens, Kenneth B Gordon, Joe Zhuo, Brandon Becker, Yichen Zhong, Renata M Kisa, Subhashis Banerjee, Kim A Papp
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引用次数: 0

摘要

简介德拉瓦替尼是一种新型口服选择性异位酪氨酸激酶2抑制剂,在POETYK PSO-1和PSO-2研究中,德拉瓦替尼的疗效优于安慰剂和阿普司特。我们描述了这些研究中患者报告的德拉瓦替尼治疗结果与安慰剂和阿普司特的比较:两项多中心、全球性、双盲、安慰剂和活性对比剂对照研究将中重度斑块状银屑病患者按1:2:1的比例随机分配给安慰剂、每天一次、每次6毫克的deucravacitinib或每天两次、每次30毫克的apremilast。评估了银屑病症状和体征日记(PSSD)和皮肤病生活质量指数(DLQI)与基线相比的评分变化以及患者内部有意义的变化反应:结果:在 POETYK PSO-1(n = 666)和 PSO-2(n = 1020)中,与安慰剂(- 4.4和-5.9)和阿普瑞司特(-18.9和-22.5)相比,在第16周和第24周,德拉瓦替尼(-32.8和-30.7;阿普瑞司特:-21.6和-22.8)和阿普瑞司特(-18.9和-22.5)相比(名义P与阿普司特和安慰剂相比,Deucravacitinib对中重度斑块状银屑病患者的患者报告结果有明显改善:NCT03624127、NCT03611751。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials.

Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials.

Introduction: Deucravacitinib, a novel, oral, selective allosteric tyrosine kinase 2 inhibitor, demonstrated superiority versus placebo and apremilast in the POETYK PSO-1 and PSO-2 studies. We describe patient-reported outcomes with deucravacitinib treatment versus placebo and apremilast in these studies.

Methods: Two multicenter, global, double-blind, placebo- and active comparator-controlled studies randomized patients with moderate-to-severe plaque psoriasis 1:2:1 to placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. Score changes from baseline and meaningful within-patient change responses for Psoriasis Symptoms and Signs Diary (PSSD) and Dermatology Life Quality Index (DLQI) were assessed.

Results: In POETYK PSO-1 (n = 666) and PSO-2 (n = 1020), respectively, improvement from baseline in PSSD total score was greater with deucravacitinib (- 27.8 and - 30.1) versus placebo (- 4.4 and - 5.9) and apremilast (- 18.9 and - 22.5) at Week 16 and versus apremilast at Week 24 (deucravacitinib: - 32.8 and - 30.7; apremilast: - 21.6 and - 22.8) (nominal p < 0.0001). Improvement from baseline in DLQI score was also greater with deucravacitinib (- 8.5 and - 7.6) versus placebo (- 3.3 and - 3.0) and apremilast (- 5.9 and - 5.8) at Week 16 and versus apremilast at Week 24 (deucravacitinib: - 8.6 and - 7.5; apremilast: - 5.6 and - 5.5) (nominal p < 0.0001). Achievement of meaningful within-patient change in PSSD total score and in DLQI score occurred more frequently with deucravacitinib than placebo and apremilast at Week 16 and versus apremilast at Week 24.

Conclusions: Deucravacitinib demonstrated meaningful improvements in patient-reported outcomes in patients with moderate-to-severe plaque psoriasis compared with apremilast and placebo.

Clinical trial registration: NCT03624127, NCT03611751.

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来源期刊
Dermatology and Therapy
Dermatology and Therapy Medicine-Dermatology
CiteScore
6.00
自引率
8.80%
发文量
187
审稿时长
6 weeks
期刊介绍: Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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