Deucravacitinib in plaque psoriasis: A subgroup analysis of Japanese patients in the POETYK PSO-1, PSO-4, and LTE trials

Deucravacitinib is an oral selective, allosteric TYK2 inhibitor approved in the US, EU, and other countries for the treatment of plaque psoriasis. Deucravacitinib demonstrated sustained clinical responses over 1 year in the POETYK PSO-1 (NCT03624127) and POETYK PSO-4 (NCT03924427) phase III clinical trials. Patients who completed these trials were eligible for the long-term extension POETYK LTE (NCT04036435) trial, where they received deucravacitinib 6 mg once daily. 

Morita et al. has published a subgroup analysis in The Journal of Dermatology, evaluating the long-term safety and efficacy of deucravacitinib in Japanese patients with moderate to severe plaque psoriasis enrolled in the POETYK PSO-1, PSO-4, and LTE trials.¹The pooled analysis included 125 Japanese patients who received at least one dose of deucravacitinib in the PSO-1/LTE (n = 62) and PSO-4/LTE (n = 63) trials. Safety and efficacy were evaluated over 3 years (148 weeks, with a data cutoff of June 15, 2022). 

Key learnings

The EAIRs for AEs, SAEs, and AEs leading to treatment discontinuation with deucravacitinib at 3 years were 188.5, 7.4, and 3.2 per 100 PYs, respectively.  

The most common AEs were nasopharyngitis and psoriasis (EAIRs, 20.0 and 5.6 per 100 PYs, respectively) with no deaths reported. The EAIRs for serious infections, herpes zoster, MACE, and malignancies were 1.3, 1.6, 0.6, and 1.0 per 100 PYs, respectively. 

Patients receiving deucravacitinib in PSO-1 and PSO-4 as well as those switching from placebo to deucravacitinib at 16 weeks in PSO-1, maintained high rates of PASI 75 (87.5%, 83.3%, and 91.7%) and sPGA 0/1 (66.7%, 83.3%, and 91.7%) through 3 years, respectively.  

The acceptable safety profile and durable efficacy of deucravacitinib in patients with moderate-to-severe plaque psoriasis are further supported by this subgroup analysis of Japanese patients.