按基线银屑病面积和严重程度指数 (PASI) 和基线体表面积 (BSA) 划分的口服选择性异位酪氨酸激酶 2 (TYK2) 抑制剂 Deucravacitinib 对头皮银屑病的疗效:对 3 期临床试验数据的子分析

Andrew Blauvelt, H. Sofen, Jo Lambert, Joseph F. Merola, M. Lebwohl, K. Hoyt, Subhashis Banerjee, Thomas Scharnitz, Jeffrey J. Crowley
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引用次数: 0

摘要

简介Deucravacitinib是一种口服、选择性、异位TYK2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。在为期52周的全球3期POETYK PSO-1(NCT03624127)和POETYK PSO-2(NCT03611751)试验中,Deucravacitinib疗效显著,耐受性良好。在此,我们根据试验中头皮受累患者的银屑病基线严重程度评估了德拉瓦替尼对头皮银屑病的疗效。研究方法基线时头皮受累程度为中度至重度(头皮特异性医生总体评估[ss-PGA]≥3)的患者被纳入本次分析。疗效结果(ss-PGA 0/1和银屑病头皮严重程度指数[PSSI] 90)报告至第24周(PSO-1/PSO-2汇总,PSO-2重新随机化前,n=514)和第52周(PSO-1,持续去氯法替尼治疗,n=192)。结果按基线 PASI 评分 12-15% (高)进行分层。结果:在第24周(分别为65.8%和58.3%)和第52周(分别为73.5%和60.0%),PASI高的亚组与PASI低的亚组相比,ss-PGA 0/1应答率较高且略高。同样,在第 24 周(55.3% 和 45.8%)和第 52 周(66.0% 和 53.3%),PSSI 90 反应率在 PASI 高的亚组与 PASI 低的亚组中也较高(分别为 55.3% 和 45.8%)和较高(分别为 66.0% 和 53.3%)。在第 24 周和第 52 周,两个基线 BSA 亚组的 ss-PGA 0/1 和 PSSI 90 反应率相当。结论无论总体基线疾病严重程度如何,Deucravacitinib治疗对头皮受累的银屑病患者均有效。
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Efficacy of Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 (TYK2) Inhibitor, in Scalp Psoriasis by Baseline Psoriasis Area and Severity Index (PASI) and Baseline Body Surface Area (BSA): A Subanalysis of the Phase 3 Clinical Trial Data
Introduction: Deucravacitinib, an oral, selective, allosteric TYK2 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 effective and well tolerated in the global, 52-week, phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials. Here, efficacy of deucravacitinib in scalp psoriasis was evaluated by baseline severity of psoriasis in the trial patients with scalp involvement. Methods: Patients with moderate to severe scalp involvement (scalp-specific Physician Global Assessment [ss-PGA] ≥3) at baseline were included in this analysis. Efficacy outcomes (ss-PGA 0/1 and Psoriasis Scalp Severity Index [PSSI] 90) were reported through Week 24 (pooled PSO-1/PSO-2, before PSO-2 rerandomization, n=514) and Week 52 (PSO-1, continuous deucravacitinib treatment, n=192). Outcomes were stratified by baseline PASI score 12-<15 (low) or ≥15 (high) and baseline BSA involvement 10%-≤15% (low) or >15% (high). Results: ss-PGA 0/1 response rates were high and slightly greater in the high versus low PASI subgroup at Week 24 (65.8% and 58.3%, respectively) and Week 52 (73.5% and 60.0%). Similarly, PSSI 90 response rates were high and also somewhat greater in the high versus low PASI subgroup at Week 24 (55.3% and 45.8%) and Week 52 (66.0% and 53.3%). Across the 2 baseline BSA subgroups, ss-PGA 0/1 and PSSI 90 response rates were comparable at Weeks 24 and 52. Conclusion: Deucravacitinib treatment was effective in patients with scalp involvement in psoriasis regardless of overall baseline disease severity.
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