Deucravacitinib, an oral selective allosteric tyrosine kinase 2 inhibitor, in patients from China mainland, Taiwan and South Korea with moderate-to-severe plaque psoriasis: a phase III randomized clinical trial

Background Deucravacitinib, an oral selective allosteric tyrosine kinase 2 inhibitor, is approved in the USA, the European Union, Japan, South Korea, China and other countries for the treatment of moderate-to-severe plaque psoriasis. Objectives To evaluate the efficacy and safety of deucravacitinib in Asian patients with moderate-to-severe plaque psoriasis. Methods In the 52-week blinded phase III POETYK PSO-3 trial (NCT04167462), patients were randomized 1 : 2 to placebo (n = 74) or deucravacitinib 6 mg once daily (n = 146) for 16 weeks followed by deucravacitinib alone. Co-primary endpoints were the achievement of a >= 75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician Global Assessment score of 0 (clear) or 1 (almost clear; sPGA 0/1) at week 16. Efficacy and safety were evaluated throughout. Results At week 16, significantly higher proportions of patients receiving deucravacitinib compared with placebo achieved PASI 75 (68.8% vs. 8.1%; P < 0.001) and sPGA 0/1 (55.6% vs. 6.8%; P < 0.001). Response rates with deucravacitinib were maintained through week 52. Common adverse events (AEs) included upper respiratory tract infection and nasopharyngitis. Serious AE and discontinuation rates were low. Conclusions Deucravacitinib was efficacious and well tolerated in Asian patients with moderate-to-severe plaque psoriasis.