Abstract：
Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in Japan for adult patients with plaque (PP), generalized pustular (GPP), and erythrodermic (EP) psoriasis who have had an inadequate response to conventional systemic therapies. This approval is based on results from the global phase 3 POETYK PSO-1 and PSO-2 trials in which deucravacitinib was associated with significantly improved efficacy outcomes compared with placebo in adults with moderate to severe plaque psoriasis, and results described here from POETYK PSO-4, an open-label, single-arm, phase 3 trial (NCT03924427), which evaluated the efficacy and safety of deucravacitinib 6 mg once daily in adult Japanese patients with PP, GPP, or EP. The coprimary endpoints were the proportion of patients achieving a ≥75% reduction from baseline in the Psoriasis Area and Severity Index (PASI 75) and a static Physician\'s Global Assessment score of 0 (clear) or 1 (almost clear) (sPGA 0/1) with at least a two-point improvement from baseline at week 16. Nonresponder imputation was used for missing data. Efficacy responses, adverse events (AEs), and serious AEs (SAEs) were recorded for up to 52 weeks. Seventy-four patients were treated (PP, n = 63; GPP, n = 3; EP, n = 8). At week 16, 76.2%, 66.7%, and 37.5% of patients with PP, GPP, and EP, respectively, had achieved PASI 75, and 82.5%, 0.0%, and 50.0% had achieved sPGA 0/1. Responses were overall maintained through week 52. AEs occurred in 74.6% of patients with PP, 100% of patients with GPP, and 87.5% of patients with EP. The most common AEs were nasopharyngitis and acne. Rates of SAEs and discontinuations were low. There were no deaths. Deucravacitinib was effective and well tolerated in Japanese patients with moderate to severe PP and in a limited number of patients with GPP or EP.
摘要：
Deucravitinib,一个口头，选择性,变构酪氨酸激酶2抑制剂，在日本被批准用于成人斑块（PP）患者，广义脓疱(3GPP)，和红皮病性（EP）银屑病对常规全身治疗反应不足。这项批准是基于全球3期POETYKPSO-1和PSO-2试验的结果，在这些试验中，与安慰剂相比，在中度至重度斑块状银屑病的成人中，deucravitinib的疗效结果显着改善。这里描述的结果来自POETYKPSO-4，一个开放标签，单臂,3期试验(NCT03924427),评估了ducravitinib6mg每日一次在日本成年PP患者中的疗效和安全性，3GPP,或EP。共同主要终点是银屑病面积和严重程度指数(PASI75)与静态医师全球评估评分为0(明确)或1(几乎明确)(sPGA0/1)且在第16周时与基线相比至少改善2分的患者比例。无响应者归因用于缺失数据。疗效反应，不良事件（AE），和严重AE（SAE）记录长达52周。74例患者接受了治疗(PP，n=63；3GPP，n=3；EP，n=8)。在第16周，76.2%，66.7%,和37.5%的PP患者，3GPP,EP,分别,获得了PASI75和82.5%，0.0%,50.0%达到sPGA0/1。反应总体维持至第52周。不良事件发生在74.6%的PP患者中，100%的患者，和87.5%的EP患者。最常见的AE是鼻咽炎和痤疮。严重不良事件和中止率很低。没有死亡。Deucravacitinib在日本中度至重度PP患者和有限数量的3GPP或EP患者中有效且耐受性良好。
