Phase III POETYK PSO-1, PSO-2, and PSO-LTE trials: 5-year follow-up of deucravacitinib in moderate-to-severe plaque PsO

Results from a 5-year follow-up of the phase III POETYK PSO-1 (NCT03624127), POETYK PSO-2 (NCT03611751), and POETYK PSO-long-term extension (LTE; NCT04036435) trials, evaluating deucravacitinib in adults with moderate-to-severe plaque psoriasis (PsO), were published in the American Journal of Clinical Dermatology by Armstrong et al. The pooled safety and efficacy populations included 1,519 and 513 patients, respectively. The primary endpoint was safety. 

Key data: Exposure-adjusted incidence rates (EAIRs) per 100 patient-years (PY) were comparable or decreased from Year 1 to Year 5 for adverse events (AEs; 229.23 vs 127.40), serious AEs (SAEs; 5.68 vs 5.06), and discontinuations due to AEs (4.38 vs 2.09). A similar trend was observed for AEs of interest (AEIs) from Year 1 to Year 5, including herpes zoster (EAIR/100 PY, 0.81 vs 0.58), major adverse cardiovascular events (MACE; EAIR/100 PY, 0.30 vs 0.34), venous thromboembolism (EAIR/100 PY, 0.20 vs 0.06), and malignancies (EAIR/100 PY, 1.02 vs 0.92). At Years 1 and 5, ≥75% reduction from baseline in the Psoriasis Area and Severity Index (PASI75) was achieved in 72.1% and 67.3% of patients, respectively, and static Physician Global Assessment (sPGA) 0/1 was achieved in 57.5% and 52.6%, respectively. Dermatology Life Quality Index (DLQI) 0/1 was maintained from Year 1 (52.5%) through Year 5 (45.4%). 

Key learning: Deucravacitinib demonstrated a consistent safety profile with no new safety signals and durable clinical and patient-reported efficacy outcomes over 5 years, supporting its role as a long-term treatment option for adults with moderate-to-severe plaque PsO.