斑块状银屑病中的 Deucravacitinib:POETYK PSO-1、PSO-2 和 LTE 3 期试验中的反应维持时间超过 4 年

B. Strober, Shinichi Imafuku, Carle Paul, Melinda Gooderham, L. Spelman, S. J. Seo, T. Passeron, K. Hoyt, Matthew J Colombo, Subhashis Banerjee, Matthias Augustin, L. Stein Gold, Andrew Alexis, Diamant Thaçi, M. Lebwohl, Naiem T. Issa, Michael C. Cameron
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Long-term efficacy was maintained through 3 total years of continuous treatment with no new safety signals in the ongoing LTE. \nMethods: Efficacy was further evaluated through Week 208 (4 years; data cutoff, November 1, 2023) in patients from the pooled PSO-1/PSO-2 populations who received continuous deucravacitinib from Day 1, achieved ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) at Week 16 (primary endpoint) or Week 24 (peak response), and entered the LTE. Maintenance of response assessments included PASI 75, PASI 90, and sPGA 0/1 (static Physician Global Assessment score of 0 [clear]/1 [almost clear]). Efficacy is reported using modified nonresponder imputation in patients who reached or discontinued before Week 208. \nResults: Of 513 patients who received continuous deucravacitinib from Day 1 and entered the LTE, PASI 75 was achieved by 313 (61.0%) and 336 (65.5%) patients at Week 16 and Week 24. 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引用次数: 0

摘要

简介在针对中度至重度斑块状银屑病的两项全球性三期试验(POETYK PSO-1和PSO-2)中,选择性异位TYK2口服抑制剂Deucravacitinib的疗效优于安慰剂和阿普司特。在第52周时,患者可以进入POETYK长期扩展(LTE)试验,接受开放标签的deucravacitinib治疗。在持续3年的LTE治疗中,患者的长期疗效得以保持,且未出现新的安全性信号。治疗方法在第208周(4年;数据截止日期为2023年11月1日)之前,对PSO-1/PSO-2汇总组患者的疗效进行了进一步评估,这些患者从第1天开始连续接受德拉瓦替尼治疗,在第16周(主要终点)或第24周(峰值应答)时,银屑病面积和严重程度指数(PASI 75)较基线下降≥75%,并进入LTE。维持反应评估包括 PASI 75、PASI 90 和 sPGA 0/1(静态医生总体评估得分 0 [清晰]/1 [基本清晰])。疗效报告采用修正的非应答者估算方法,对第 208 周前达到或停止治疗的患者进行估算。结果513名患者从第1天开始连续接受去氯法替尼治疗并进入LTE,其中313名患者(61.0%)和336名患者(65.5%)在第16周和第24周达到了PASI 75。在第 16 周 PASI 75 有反应的患者中,反应率从第 16 周到第 208 周均保持良好(PASI 75:100%,84.4%;PASI 90:55.7%,57.4%;sPGA 0/1:82.8%,65.4%)。在第 24 周 PASI 75 反应者中,反应率从第 24 周到第 208 周也保持不变(PASI 75:100%,84.6%;PASI 90:62.7%,58.2%;sPGA 0/1:82.5%,66.0%)。结论在母体试验中,绝大多数第16周和第24周PASI 75有反应的患者在持续服用deucravacitinib 4年后仍能保持临床疗效,这支持了每日一次口服deucravacitinib治疗中度至重度斑块状银屑病的长期有效性和治疗持久性。
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Deucravacitinib in Plaque Psoriasis: Maintenance of Response Over 4 Years in the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Introduction: Deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, was superior to placebo and apremilast in two global, phase 3 trials (POETYK PSO-1 and PSO-2) in moderate to severe plaque psoriasis. At Week 52, patients could enter the POETYK long-term extension (LTE) trial and receive open-label deucravacitinib. Long-term efficacy was maintained through 3 total years of continuous treatment with no new safety signals in the ongoing LTE. Methods: Efficacy was further evaluated through Week 208 (4 years; data cutoff, November 1, 2023) in patients from the pooled PSO-1/PSO-2 populations who received continuous deucravacitinib from Day 1, achieved ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) at Week 16 (primary endpoint) or Week 24 (peak response), and entered the LTE. Maintenance of response assessments included PASI 75, PASI 90, and sPGA 0/1 (static Physician Global Assessment score of 0 [clear]/1 [almost clear]). Efficacy is reported using modified nonresponder imputation in patients who reached or discontinued before Week 208. Results: Of 513 patients who received continuous deucravacitinib from Day 1 and entered the LTE, PASI 75 was achieved by 313 (61.0%) and 336 (65.5%) patients at Week 16 and Week 24. Among Week 16 PASI 75 responders, response rates were maintained well from Week 16 to Week 208 (PASI 75: 100%, 84.4%; PASI 90: 55.7%, 57.4%; sPGA 0/1: 82.8%, 65.4%). Among Week 24 PASI 75 responders, response rates were also maintained from Week 24 to Week 208 (PASI 75: 100%, 84.6%; PASI 90: 62.7%, 58.2%; sPGA 0/1: 82.5%, 66.0%). Conclusion: Clinical efficacy was generally maintained with continuous deucravacitinib in the vast majority of Week 16 and Week 24 PASI 75 responders from the parent trials through 4 years, supporting the long-term effectiveness and treatment durability of once-daily oral deucravacitinib for moderate to severe plaque psoriasis.
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