POETYK PSO-1、PSO-2 和 LTE 3 期项目中第 16 周安慰剂交叉患者服用 Deucravacitinib 4 年后的长期疗效

M. Lebwohl, Richard B Warren, Shinichi Imafuku, J. Bagel, April W. Armstrong, T. Passeron, Subhashis Banerjee, Matthew J Colombo, Thomas Scharnitz, K. Hoyt, Diamant Thaçi, Andrew Blauvelt
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Efficacy is reported using modified nonresponder imputation (mNRI) in patients who reached the Week 208 assessment or discontinued before Week 208. \nResults: Of 421 patients originally randomized to placebo, 348 crossed over to deucravacitinib at Week 16; 298 completed the parent trials and entered the LTE, with 291 meeting mNRI criteria. Efficacy response rates improved from Week 16 on placebo (PASI 75, 12.0% [95% CI, 8.5%-16.3%]; PASI 90, 3.4% [1.7%-6.2%]; sPGA 0/1, 10.0% [6.8%-14.0%]) through Week 52 on deucravacitinib (PASI 75, 75.2% [70.2%-80.2%]; PASI 90, 47.4% [41.6%-53.1%]; sPGA 0/1, 60.1% [54.5%-65.7%]). 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引用次数: 0

摘要

简介Deucravacitinib是一种口服、选择性、异位酪氨酸激酶2抑制剂,已在美国、欧盟和其他国家获得批准,用于治疗可接受系统疗法的中重度斑块状银屑病成人患者。在两项为期52周的全球3期POETYK PSO-1(NCT03624127)和POETYK PSO-2(NCT03611751)母体试验中,以及在POETYK长期扩展(LTE)(NCT04036435)试验中,从PSO-1/PSO-2第1天开始接受deucravacitinib治疗的患者中,deucravacitinib具有良好的疗效和耐受性。在此,我们对在PSO-1或PSO-2中第16周从安慰剂转为服用deucravacitinib并进入LTE试验的患者4年的长期疗效进行了评估。研究方法PSO-1和PSO-2将患者按1:2:1的比例随机分配到口服安慰剂、每天一次、每次6毫克的deucravacitinib或每天两次、每次30毫克的apremilast。第16周,随机接受安慰剂治疗的患者转为接受deucravacitinib治疗。第52周时,患者可加入LTE,接受开放标签的deucravacitinib治疗。疗效评估的对象是在母体试验第16周从安慰剂转为服用德拉瓦替尼并持续服用德拉瓦替尼4年(第208周;数据截止日期为2023年11月1日)的患者。疗效包括银屑病面积和严重程度指数(PASI 75/90)较基线下降≥75%/≥90%,以及静态医生总体评估评分为0(清晰)或1(基本清晰)(sPGA 0/1)。疗效报告采用修正的无应答者归因(mNRI)方法,对达到第 208 周评估标准或在第 208 周前停药的患者进行归因。结果:在最初随机接受安慰剂治疗的421名患者中,有348名患者在第16周时接受了deucravacitinib治疗;298名患者完成了母体试验并进入LTE,其中291名患者符合mNRI标准。从第 16 周开始,安慰剂的疗效反应率有所提高(PASI 75,12.0% [95% CI,8.5%-16.3%];PASI 90,3.4% [1.7%-6.2%];sPGA 0/1,10.0% [6.8%-14.0%])。PASI90,47.4% [41.6%-53.1%];sPGA 0/1,60.1% [54.5%-65.7%])。反应率在第 208 周保持良好(PASI 75,75.6% [70.0%-81.2%];PASI 90,46.6% [40.4%-52.7%];sPGA 0/1,55.1% [48.8%-61.4%])。结论这些研究结果支持每日口服一次的德拉瓦替尼治疗中重度斑块状银屑病患者的长期疗效。
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Deucravacitinib Long-Term Efficacy Through 4 years in Week 16 Placebo Crossover Patients in the Phase 3 POETYK PSO-1, PSO-2, and LTE Program
Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was efficacious and well tolerated in two global, 52-week, phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) parent trials, and through 2 additional years in the POETYK long-term extension (LTE) (NCT04036435) trial in patients treated with deucravacitinib from Day 1 of PSO-1/PSO-2. Here, long-term efficacy was assessed through 4 years in patients who crossed over from placebo to deucravacitinib at Week 16 in PSO-1 or PSO-2 and entered the LTE trial. Methods: PSO-1 and PSO-2 randomized patients 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. At Week 16, patients randomized to placebo crossed over to deucravacitinib. At Week 52, patients could enroll in the LTE and receive open-label deucravacitinib. Efficacy was evaluated in patients who crossed over from placebo to deucravacitinib at Week 16 of the parent trial and received continuous deucravacitinib through 4 years (Week 208; data cutoff, November 1, 2023). Outcomes included ≥75%/≥90% reduction from baseline in Psoriasis Area and Severity Index (PASI 75/90) and static Physician Global Assessment score of 0 (clear) or 1 (almost clear) (sPGA 0/1). Efficacy is reported using modified nonresponder imputation (mNRI) in patients who reached the Week 208 assessment or discontinued before Week 208. Results: Of 421 patients originally randomized to placebo, 348 crossed over to deucravacitinib at Week 16; 298 completed the parent trials and entered the LTE, with 291 meeting mNRI criteria. Efficacy response rates improved from Week 16 on placebo (PASI 75, 12.0% [95% CI, 8.5%-16.3%]; PASI 90, 3.4% [1.7%-6.2%]; sPGA 0/1, 10.0% [6.8%-14.0%]) through Week 52 on deucravacitinib (PASI 75, 75.2% [70.2%-80.2%]; PASI 90, 47.4% [41.6%-53.1%]; sPGA 0/1, 60.1% [54.5%-65.7%]). Response rates were maintained well through Week 208 (PASI 75, 75.6% [70.0%-81.2%]; PASI 90, 46.6% [40.4%-52.7%]; sPGA 0/1, 55.1% [48.8%-61.4%]). Conclusion: These findings support the long-term efficacy profile of once-daily oral deucravacitinib for treatment of patients with moderate to severe plaque psoriasis.
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