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.