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 3 randomized clinical trial.

Abstract

Background: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the United States, European Union, Japan, South Korea, China, and other countries for treatment of moderate-to-severe plaque psoriasis.

Objective: To evaluate the efficacy and safety of deucravacitinib in Asian patients with moderate to severe plaque psoriasis.

Methods: In the 52-week, blinded, phase 3 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. Coprimary endpoints were achievement of ≥ 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 versus placebo achieved PASI 75 (68.8% vs. 8.1%; P < 0.0001) and sPGA 0/1 (55.6% vs. 6.8%; P < 0.0001). Response rates with deucravacitinib were maintained through Week 52. Common adverse events included upper respiratory tract infection and nasopharyngitis. Serious adverse event and discontinuation rates were low.

Conclusions: Deucravacitinib was efficacious and well tolerated in Asian patients with moderate to severe plaque psoriasis.