作者
Jianzhong Zhang,Yangfeng Ding,Ping Wang,Linfeng Li,Weili Pan,Yan Lü,Hao Cheng,Xian Jiang,Ji‐Chen Ho,Shuping Guo,Seong Jun Seo,Linda Stein Gold,Andrew Blauvelt,Joe Zhuo,Yichen Zhong,Brandon Becker,L. Liu,Subhashis Banerjee,Diamant Thaçi
摘要
ABSTRACT POETYK PSO‐3, a 52‐week, double‐blind, phase 3 study, evaluated the efficacy and safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in adult patients with moderate to severe plaque psoriasis in mainland China, Taiwan, and South Korea. Secondary and additional endpoints included improvement on two patient‐reported outcome measures: the Psoriasis Symptoms and Signs Diary (PSSD) total score and the Dermatology Life Quality Index (DLQI). Patients were randomized 1:2 to placebo or deucravacitinib 6 mg once daily; at week 16, patients receiving placebo crossed over to receive deucravacitinib. PSSD and DLQI score changes from baseline and response rates for achieving meaningful within‐patient change from baseline in PSSD total score (≥ 15 points) and DLQI of 0 or 1 (DLQI 0/1) were assessed over 52 weeks. In POETYK PSO‐3, 74 patients were randomized to placebo and 146 patients to deucravacitinib. At week 16, mean (95% confidence interval [CI]) PSSD total score changes from baseline were −1.9 (−6.9, 3.1) and −28.8 (−32.6, −25.0) in patients receiving placebo and deucravacitinib, respectively. At both weeks 16 and 52, the response rate for ≥ 15‐point meaningful change in PSSD total score (95% CI) was 73.3% (65.3, 80.3) in the group randomized to deucravacitinib. At week 16, mean (95% CI) DLQI changes from baseline were −1.7 (−3.1, −0.4) and −7.4 (−8.4, −6.4) in patients receiving placebo and deucravacitinib, respectively. In patients randomized to deucravacitinib, DLQI 0/1 response rates (95% CI) at weeks 16 and 52 were 36.4% (28.5, 44.4) and 44.7% (36.5, 52.9), respectively. Deucravacitinib was associated with meaningful and sustained improvements in psoriasis symptoms and signs and in quality of life in Asian patients with moderate to severe plaque psoriasis. Trial Registration: ClinicalTrials.gov identifier: NCT04167462