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Deucravacitinib, a selective, TYK2 inhibitor, in psoriatic arthritis: Achievement of minimal disease activity components in a phase 2 trial
Rheumatology ( IF 4.7 ) Pub Date : 2024-10-18 , DOI: 10.1093/rheumatology/keae580
Arthur Kavanaugh, Laura C Coates, Philip J Mease, Miroslawa Nowak, Lauren Hippeli, Thomas Lehman, Subhashis Banerjee, Joseph F Merola

Objectives Deucravacitinib is a novel, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor belonging to a distinct class of enzyme inhibitors. In a phase 2 trial in psoriatic arthritis (NCT03881059), deucravacitinib was significantly more efficacious than placebo across multiple endpoints, including achieving minimal disease activity (MDA). This post hoc analysis further evaluated the achievement of individual components of the MDA criteria with deucravacitinib treatment and the time course of responses in the phase 2 trial. Methods Patients (N = 203) were randomized 1:1:1 to once daily treatment with placebo, deucravacitinib 6 mg, or deucravacitinib 12 mg. The proportions of patients achieving MDA and each of the 7 individual MDA components through week 16 were assessed. Results At baseline, although some patients met criteria for individual MDA components, none of the patients met the composite MDA criterion, and all components were balanced overall across treatment arms. Treatment with deucravacitinib was associated with a numerically greater mean reduction from baseline in all MDA components vs placebo over 16 weeks of treatment. At week 16, a greater percentage of patients treated with either dose of deucravacitinib vs placebo achieved the threshold criteria for meeting MDA in each of the components. Conclusions More patients treated with deucravacitinib met each of the MDA components vs placebo, along with a higher rate of MDA response, after 16 weeks of treatment.

中文翻译:


Deucravacitinib,一种选择性 TYK2 抑制剂,治疗银屑病关节炎:在 2 期试验中实现最小的疾病活动成分



目的 Deucravacitinib 是一种新型、口服、选择性、变构酪氨酸激酶 2 (TYK2) 抑制剂,属于一类独特的酶抑制剂。在银屑病关节炎 (sO) 的一项 2 期试验 (NCT03881059) 中,deucravacitinib 在多个终点(包括达到最小疾病活动度 (MDA)的疗效明显优于安慰剂。该事后分析进一步评估了 deucravacitinib 治疗对 MDA 标准各个组成部分的实现情况以及 2 期试验中反应的时间进程。方法 患者 (N = 203) 以 1:1:1 的比例随机分配至每日一次安慰剂、deucravacitinib 6 mg 或 deucravacitinib 12 mg 治疗。评估了第 16 周达到 MDA 的患者比例和 7 个单独的 MDA 组成部分中的每一种。结果 在基线时,虽然一些患者符合单个 MDA 成分的标准,但没有一个患者符合复合 MDA 标准,并且所有成分在治疗组之间总体上是平衡的。在治疗 16 周内,与安慰剂相比,deucravacitinib 治疗的所有 MDA 成分相对于基线的平均减少在数值上更大。在第 16 周时,接受任一剂量的 deucravacitinib 与安慰剂治疗的患者达到每个成分满足 MDA 的阈值标准的百分比更高。结论 治疗 16 周后,与安慰剂相比,接受 deucravacitinib 治疗的患者更多满足每个 MDA 成分,并且 MDA 反应率更高。
更新日期:2024-10-18
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