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.

• Tác giả: Subhashis Banerjee, Arkendu Chatterjee, Hao Cheng, Yangfeng Ding, Shuping Guo, Ji-Chen Ho, Xian Jiang, Renata M Kisa, Linfeng Li, Leona Liu, Yan Lu, Weili Pan, Ping Wang, Jianzhong Zhang
• Ngôn ngữ: eng
• Ký hiệu phân loại: 553.453 Tin
• Thông tin xuất bản: England : The British journal of dermatology , 2025
• Bộ sưu tập: NCBI
• ID: 174698

Tóm tắt

 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.