Deucravacitinib in moderate-to-severe plaque psoriasis: 5-year results from the POETYK PSO-1, PSO-2, and LTE trials

The phase III POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials demonstrated that deucravacitinib 6 mg once daily was significantly effective and well tolerated compared with placebo and apremilast at Week 16 in patients with moderate-to-severe plaque psoriasis. Patients who completed these trials were eligible to enroll in the ongoing POETYK long-term extension (LTE) trial (NCT04036435) to continue treatment with open-label deucravacitinib.¹

During the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress, June 11–14, 2025, Barcelona, ES, April Armstrong presented long-term efficacy and safety outcomes of deucravacitinib treatment over 5 years in patients with moderate-to-severe plaque psoriasis enrolled in the POETYK PSO-1, PSO-2, and LTE trials. The safety analysis included 1,519 patients who received ≥1 dose of deucravacitinib, while the efficacy analysis comprised 513 patients who received continuous treatment over the 5-year period.¹

Key learnings

In the efficacy set, PASI 75, PASI 90, and sPGA 0/1 response rates with deucravacitinib were sustained from 1 year (72.1%, 45.9%, and 57.5%, respectively) through 5 years (67.3%, 46.3%, and 52.6%, respectively).

Over the 5-year period, deucravacitinib maintained a stable safety profile. Incidence rates of AEs decreased from Year 1 (EAIR, 229.23/100 PY) to Year 5 (EAIR, 127.40/100 PY). Nasopharyngitis and URTI remained the most common AEs.

The EAIR for serious infections (1.93/100 PY), MACE (0.34/100 PY), and malignancies (0.92/100 PY) through 5 years remained low and were consistent with clinical trials and real-world safety data of other approved psoriasis treatments.

Deucravacitinib demonstrated a consistent safety profile with no new safety signals and sustained clinical efficacy over 5 years.