Deucravacitinib:斑块型银屑病 3 期临床试验的实验室参数。

IF 3.5 3区 医学 Q1 DERMATOLOGY
Dermatology and Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-20 DOI:10.1007/s13555-025-01362-w
April W Armstrong, Leon Kircik, Linda Stein Gold, Bruce Strober, Claudia H M C De Oliveira, John Vaile, Ying-Ming Jou, Carolin Daamen, Thomas Scharnitz, Mark Lebwohl
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引用次数: 0

摘要

Deucravacitinib是一种口服、选择性、变质酪氨酸激酶2抑制剂,在美国和其他国家被批准用于治疗中度至重度斑块性银屑病的成人患者,这些患者是全身治疗的候选人。在POETYK PSO-1和PSO-2中,deucravacitinib优于安慰剂和阿普雷米司特,并且在斑块型银屑病患者中耐受性良好。完成PSO-1/PSO-2的患者可以参加POETYK长期延长(LTE)试验。本分析评估了deucravacitinib对实验室参数的影响。方法:POETYK PSO-1和PSO-2是为期52周的3期双盲试验,将患者以1:2:1随机分配到安慰剂,deucravacitinib 6 mg每日一次,或apremilast 30 mg每日两次。在第52周,符合条件的患者入组POETYK LTE并接受开放标签deucravacitinib。从基线到实验室参数、实验室不良事件(ae)和导致停药的实验室ae的平均变化在3年内进行评估。结果:共有1519名患者接受了一个或多个剂量的deucravacitinib。3年的总暴露量为3294.3人年。实验室参数未见临床相关的平均变化。≥3级实验室ae在1年期间很少发生,在deucravacitinib治疗的患者中,发生率在3年内保持稳定。大多数实验室ae保持在同一等级;向更高等级的转变很少,大多数是等级≤2。由于实验室不良反应而中断的情况很少见。结论:Deucravacitinib在3年内没有导致有临床意义的实验室参数变化,包括Janus激酶(JAK) 1,2,3抑制剂的变化。≥3级实验室不良反应和停药罕见。试验注册:ClinicalTrials.gov标识符,POETYK PSO-1 (NCT03624127), POETYK PSO-2 (NCT03611751), POETYK LTE (NCT04036435)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Deucravacitinib: Laboratory Parameters Across Phase 3 Plaque Psoriasis Trials.

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the USA and other countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. In POETYK PSO-1 and PSO-2, deucravacitinib was superior to placebo and apremilast and well tolerated in patients with plaque psoriasis. Patients who completed PSO-1/PSO-2 could enroll in the POETYK long-term extension (LTE) trial. This analysis evaluates the effects of deucravacitinib on laboratory parameters.

Methods: POETYK PSO-1 and PSO-2 were 52-week, phase 3, double-blinded trials that randomized patients 1:2:1 to placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. At week 52, eligible patients enrolled in POETYK LTE and received open-label deucravacitinib. Mean changes from baseline in laboratory parameters, laboratory adverse events (AEs), and laboratory AEs resulting in discontinuation were evaluated over 3 years.

Results: A total of 1519 patients received one or more doses of deucravacitinib across trials. Total exposure over 3 years was 3294.3 person-years. No clinically relevant mean changes were observed in laboratory parameters. Grade ≥ 3 laboratory AEs were infrequent during the 1-year period, with incidence rates remaining stable in patients treated with deucravacitinib through 3 years. Most laboratory AEs remained at the same grade; shifts to higher grades were infrequent, with most increases being to grade ≤ 2. Discontinuations due to laboratory AEs were rare.

Conclusions: Deucravacitinib did not result in clinically meaningful changes in laboratory parameters over 3 years, including changes seen with Janus kinase (JAK) 1,2,3 inhibitors. Grade ≥ 3 laboratory AEs and discontinuations were rare.

Trial registration: ClinicalTrials.gov identifier, POETYK PSO-1 (NCT03624127), POETYK PSO-2 (NCT03611751), POETYK LTE (NCT04036435).

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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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