Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: Efficacy by Baseline Demographic and Disease Characteristics in the Phase 3 POETYK PSO-1 and PSO-2 Trials

M. Gooderham, L. Spelman, S. Imafuku, M. Romanelli, J. Merola, A. Armstrong, E. Colston, Subhashish Banerjee, T. Scharnitz, A. Blauvelt
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Abstract

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US and other countries for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In the POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) trials, deucravacitinib was superior to placebo and apremilast in patients with moderate to severe plaque psoriasis. This analysis evaluated deucravacitinib efficacy by baseline characteristics. Methods: Efficacy endpoints, including ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician’s Global Assessment score of 0 (clear) or 1 (almost clear) (sPGA 0/1), were evaluated at Week 24 by baseline subgroups including weight, sex, and PASI in the pooled PSO-1 and PSO-2 population, and at Week 52 in PSO-1 patients who received continuous deucravacitinib treatment from Day 1. Results: In the pooled PSO-1 and PSO-2 population, deucravacitinib (n=843) was more efficacious than apremilast (n=422) at Week 24 across subgroups defined by baseline weight (<90 kg: PASI 75, 69.8% vs 43.8%, sPGA 0/1, 60.2% vs 34.2%; ≥90 kg: PASI 75, 55.4% vs 31.5%, sPGA 0/1, 45.9% vs 25.6%), sex (male: PASI 75, 59.3% vs 33.7%, sPGA 0/1, 49.6% vs 24.7%; female: PASI 75, 70.4% vs 45.2%, sPGA 0/1, 60.9% vs 39.4%), and PASI (≤20: PASI 75, 61.6% vs 38.6%, sPGA 0/1, 53.5% vs 32.4%; >20: PASI 75, 64.7% vs 37.0%, sPGA 0/1: 53.2% vs 27.1%). Consistent efficacy was observed through Week 52 in patients who received continuous deucravacitinib treatment in PSO-1 (n=332), regardless of baseline characteristics. Conclusion: Deucravacitinib demonstrated consistent efficacy for up to 52 weeks regardless of baseline characteristics in patients with moderate to severe plaque psoriasis.   Acknowledgments This study was sponsored by Bristol Myers Squibb Writing and editorial assistance was provided by Liz Rockstein, PhD, of Peloton Advantage, LLC, an OPEN Health company, funded by Bristol Myers Squibb
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Deucravacitinib是一种口服、选择性、变质酪氨酸激酶2抑制剂,用于治疗中重度斑块型银屑病:POETYK PSO-1和PSO-2 3期试验中基线人口统计学和疾病特征的疗效
简介:Deurefacitinib是一种口服、选择性、变构酪氨酸激酶2抑制剂,在美国和其他国家被批准用于治疗成人中重度斑块型银屑病,这些患者是全身治疗或光疗的候选者。在POETYK PSO-1(NCT03624127)和PSO-2(NCT03611751)试验中,在中度至重度斑块型银屑病患者中,地拉帕替尼优于安慰剂和阿普司特。该分析通过基线特征评估了去乙酰替尼的疗效。方法:在第24周,通过合并PSO-1和PSO-2人群中的基线亚组(包括体重、性别和PASI)评估疗效终点,包括银屑病面积和严重程度指数(PASI 75)比基线降低≥75%,以及静态医师全球评估得分为0(明确)或1(几乎明确)(sPGA 0/1),在第52周,PSO-1患者从第1天开始接受连续的去阿替尼治疗。结果:在合并的PSO-1和PSO-2人群中,在第24周,在基线体重定义的亚组中(20:PASI 75,64.7%vs 37.0%,sPGA 0/1:53.2%vs 27.1%),去乙酰帕替尼(n=843)比阿培司特(n=422)更有效,而与基线特征无关。结论:在中度至重度斑块型银屑病患者中,无论基线特征如何,Deurefacitinib在长达52周的时间内都表现出一致的疗效。鸣谢本研究由百时美施贵宝赞助,编辑协助由百时美施贵宝资助的开放健康公司Peloton Advantage,LLC的Liz Rockstein博士提供
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