中度至重度斑块状银屑病患者52周内服用Deucravacitinib与Apremilast的累积疗效:POETYK PSO-1 后期分析。

IF 3.5 3区 医学 Q1 DERMATOLOGY Dermatology and Therapy Pub Date : 2024-07-01 Epub Date: 2024-06-22 DOI:10.1007/s13555-024-01201-4
April W Armstrong, Sang Hee Park, Vardhaman Patel, Pierre Nicolas, Wei-Jhih Wang, Matthew J Colombo, Viktor Chirikov
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引用次数: 0

摘要

简介在 POETYK PSO-1 和 PSO-2 临床试验中,德拉瓦替尼对中重度斑块状银屑病患者的疗效优于阿普司特。在本文报告的研究中,我们旨在确定开始使用去氯法替尼与阿普司特治疗52周的总体累积临床获益,并比较开始使用并坚持使用去氯法替尼与开始使用阿普司特并在治疗第24周时继续使用或改用去氯法替尼的52周累积获益:这项对POETYK PSO-1数据(ClinicalTrials.gov标识符:NCT03624127)的事后分析确定了中重度斑块状银屑病成人患者每天一次、每次6毫克的deucravacitinib和每天两次、每次30毫克的apremilast的累积临床疗效。接受阿普司特治疗的患者如果在第24周时银屑病面积和严重程度指数(PASI 50)没有达到50%的下降,则改用deucravacitinib治疗。52周内,德拉瓦替尼与阿普瑞司特的累积临床获益基于PASI评分(PASI 75)较基线改善≥75%的累积测量值,以及静态医生总体评估评分为0或1分(sPGA 0/1)的患者比例。根据协方差回归分析模型计算并比较了不同治疗方法的曲线下面积估计值之比:结果:根据PASI 75和sPGA 0/1来衡量,开始接受德拉瓦替尼治疗的患者(332人)比开始接受阿普司特治疗的患者(168人)有更大的累积获益。在52周的时间里,与阿普司特相比,根据PASI 75和sPGA 0/1来衡量,开始使用deucravacitinib的患者获益多50%,而开始使用阿普司特的患者获益多58%。根据既往接受过系统治疗和生物治疗的患者进行分类后,结果与主要分析一致:该分析结果证实了主要疗效分析结果,支持在中重度斑块状银屑病治疗中,与阿普司特相比使用去氯伐他替尼,而与既往接受过系统治疗或生物制剂治疗的患者无关。
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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Cumulative Benefit Over 52 Weeks With Deucravacitinib Versus Apremilast in Moderate to Severe Plaque Psoriasis: POETYK PSO-1 Post Hoc Analysis.

Introduction: Deucravacitinib demonstrated superior efficacy to apremilast in patients with moderate to severe plaque psoriasis in the POETYK PSO-1 and PSO-2 clinical trials. In the study reported here, we aimed to determine the overall 52-week cumulative clinical benefit of treatment initiated with deucravacitinib versus apremilast and to compare the 52-week cumulative benefit of initiating and staying on deucravacitinib versus initiating apremilast and continuing or switching to deucravacitinib at week 24 of treatment.

Methods: This post hoc analysis of POETYK PSO-1 data (ClinicalTrials.gov identifier: NCT03624127) determined the cumulative clinical benefit of deucravacitinib 6 mg once daily and apremilast 30 mg twice daily in adults with moderate to severe plaque psoriasis. Patients treated with apremilast who did not achieve a 50% reduction in the Psoriasis Area and Severity Index (PASI 50) at week 24 were switched to deucravacitinib. The cumulative clinical benefit of deucravacitinib versus apremilast over 52 weeks was based on cumulative measures of ≥ 75% improvement from baseline in PASI score (PASI 75) and the proportion of patients with a static Physician Global Assessment score of 0 or 1 (sPGA 0/1). Ratios of area under the curve estimates between treatments were calculated and compared based on analysis of covariance regression models.

Results: Patients initiating deucravacitinib (N = 332) had a greater cumulative benefit as measured by the PASI 75 and sPGA 0/1 than those initiating apremilast (N = 168). Over 52 weeks, those initiating deucravacitinib experienced 50% more benefit as measured by PASI 75 and 58% more benefit as measured by sPGA 0/1 than those initiating apremilast. Results were consistent with the primary analysis when patients were classified by prior systemic and prior biologic therapy exposure.

Conclusion: Results from this analysis corroborate the primary efficacy analysis supporting the use of deucravacitinib compared with apremilast for moderate to severe plaque psoriasis, regardless of prior systemic or biologic use.

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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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