Safety and Efficacy of Deucravacitinib in Japanese Patients With Moderate to Severe Plaque Psoriasis: 5‐Year Analysis of the Phase 3 POETYK PSO ‐1, PSO

ABSTRACT

Deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, is approved in multiple countries for the treatment of moderate to severe plaque psoriasis, as well as generalized pustular and erythrodermic psoriasis in Japan. Deucravacitinib 6 mg once daily was efficacious and well tolerated through 3 years in the pooled population of Japanese patients in the POETYK PSO‐1 and PSO‐4 trials who entered the ongoing open‐label POETYK long‐term extension trial. Safety and efficacy of deucravacitinib were evaluated through 5 years (256 weeks; data cutoff September 2, 2024) in Japanese patients who received continuous deucravacitinib in PSO‐1 or PSO‐4 or who crossed over from placebo to deucravacitinib at Week 16 in PSO‐1. Safety was evaluated via adverse event (AE) exposure‐adjusted incidence rates (EAIRs); efficacy was evaluated via endpoints including ≥ 75% reduction from baseline in the Psoriasis Area and Severity Index (PASI 75) and static Physician Global Assessment (sPGA) score of 0/1 (clear/almost clear). At data cutoff, 136 patients had received at least one deucravacitinib dose; 77.2% had > 48 months and 39.7% had > 60 months of total deucravacitinib exposure. EAIRs per 100 person‐years were 182.1 (any AEs), 6.9 (serious AEs), 3.0 (discontinuations due to AEs), 1.6 (serious infections), 1.6 (herpes zoster events), 0.5 (major adverse cardiovascular events), and 1.4 (malignancies). Clinical responses (as observed) were maintained over 5 years in PSO‐1 patients receiving continuous deucravacitinib treatment from baseline (PASI 75: Year 1, 88.9%; Year 5, 85.7%; sPGA 0/1: Year 1, 74.1%; Year 5, 71.4%); results were consistent regardless of imputation method (modified nonresponder imputation, treatment failure rule). Year 1 response rates were also maintained through Year 5 in PSO‐4 patients and in PSO‐1 patients who crossed over from placebo. These findings support the long‐term safety and durable efficacy profile of deucravacitinib through 5 years in Japanese patients with psoriasis.