Deucravacitinib: Adverse Events of Interest Across Phase 3 Plaque Psoriasis Trials.

IF 3.5 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2025-02-01 Epub Date: 2025-02-07 DOI:10.1007/s13555-025-01337-x

Joseph F Merola, Laura K Ferris, Jeffrey M Sobell, Howard Sofen, John Osborne, John Vaile, Ying-Ming Jou, Carolin Daamen, Julie Scotto, Thomas Scharnitz, Mark Lebwohl

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引用次数: 0

Abstract

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in multiple countries for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. The safety and efficacy of deucravacitinib in psoriasis has been demonstrated through 3 years in the phase 3 POETYK PSO-1, PSO-2, and long-term extension (LTE) trials enrolling adults with moderate to severe plaque psoriasis.

Methods: To review the effect of deucravacitinib treatment on adverse events of interest (AEIs) over 3 years in POETYK PSO-1, PSO-2, and LTE, cumulative exposure-adjusted incidence rates (EAIRs) of AEIs were recorded through 3 years.

Results: AEIs and 3-year EAIRs of select infections included serious infections (2.5/100 person-years [PY]), COVID-19 (1.6/100 PY), and herpes zoster (0.6/100 PY). Excluding COVID-19, the serious infections EAIR was 0.9/100 PY. Major adverse cardiovascular event (MACE) and venous thromboembolism EAIRs were 0.3/100 PY and 0.1/100 PY, respectively. The EAIRs for malignancies were 0.9/100 PY overall and 0.5/100 PY, excluding nonmelanoma skin cancer (NMSC). Cutaneous events included acne (EAIR, 1.3/100 PY) and folliculitis (EAIR, 1.1/100 PY). Three-year cumulative EAIRs generally remained stable or decreased relative to 1-year rates. EAIRs of non-COVID-19 serious infections, malignancies excluding NMSC, and MACE through 3 years were consistent with rates for other antipsoriatic agents from clinical trials, disease registries, and real-world claims data.

Conclusion: In adults with plaque psoriasis treated with deucravacitinib, the cumulative incidence of AEIs remained comparable or decreased over 3 years of follow-up and aligned with comparison data for other antipsoriatic therapies.

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Deucravacitinib：斑块型银屑病3期临床试验中关注的不良事件

Deucravacitinib是一种口服、选择性、变质酪氨酸激酶2抑制剂，已在多个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。deucravacitinib治疗银屑病的安全性和有效性已经在3年的POETYK PSO-1、PSO-2和长期扩展（LTE）试验中得到证实，该试验招募了中度至重度斑块性银屑病的成人患者。方法：为了回顾deucravacitinib治疗对POETYK PSO-1、PSO-2和LTE患者3年内的不良事件（AEIs）的影响，记录3年内的累积暴露调整发生率（EAIRs）。结果：选定感染的aei和3年eair包括严重感染（2.5/100人年[PY]）、COVID-19 （1.6/100 PY）和带状疱疹（0.6/100 PY）。除COVID-19外，严重感染的EAIR为0.9/100 PY。主要不良心血管事件（MACE）和静脉血栓栓塞eair分别为0.3/100 PY和0.1/100 PY。恶性肿瘤的EAIRs为总体0.9/100 PY和0.5/100 PY，不包括非黑色素瘤皮肤癌（NMSC）。皮肤事件包括痤疮（EAIR, 1.3/100 PY）和毛囊炎（EAIR, 1.1/100 PY）。相对于1年期利率，3年期累积eair一般保持稳定或下降。3年内，非covid -19严重感染、恶性肿瘤（不包括NMSC）和MACE的发生率与临床试验、疾病登记和现实世界索赔数据中其他抗银屑病药物的发生率一致。结论：在接受deucravacitinib治疗的斑块型银屑病成人患者中，AEIs的累积发生率在3年随访期间保持相当或下降，并与其他抗银屑病治疗的比较数据一致。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

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.