Bristol Myers Squibb released new three-year results from the POETYK PSO long-term extension (LTE) trial evaluating Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. At Week 148, continuous treatment demonstrated sustained clinical response rates, with modified nonresponder imputation (mNRI) responses of 73.2% for Psoriasis Area and Severity Index (PASI) 75, 48.1% for PASI 90, and 54.1% for static Physician’s Global Assessment (sPGA) 0/1. Sotyktu exhibited a consistent safety profile, showing no increase in adverse events (AEs) or serious AEs over time, and no emergence of new safety signals.
These findings were presented at the European Academy of Dermatology and Venereology (EADV) Congress in Berlin, Germany from October 11-14, 2023. This oral presentation, along with 49 additional abstracts, underscores Bristol Myers Squibb's continued dedication to dermatology research.
The safety analysis encompassed 1,519 patients who received at least one dose of Sotyktu across POETYK PSO-1, POETYK PSO-2, and POETYK PSO-LTE. The efficacy analysis involved 513 patients who received continuous Sotyktu treatment from Day 1 in the pivotal POETYK PSO-1 and POETYK PSO-2 trials and transitioned to the LTE trial. Cumulative exposure from parent trial randomization was 3,294 patient-years (PYs) for the safety analyses.
Efficacy outcomes remained consistent in patients continuously treated with Sotyktu from baseline through Week 148, with sustained response rates for PASI 75 (Week 16, 61.1%; Week 52, 72.6%; Week 148, 73.2%), PASI 90 (Week 16, 35.2%; Week 52, 45.6%; Week 148, 48.1%), and sPGA 0/1 (Week 16, 57.5%; Week 52, 58.1%; Week 148, 54.1%).
At three years, cumulative exposure-adjusted incidence rates (EAIRs)/100 PYs were either stable or decreased compared to rates observed at two years for AEs (144.8, 154.4), serious AEs (5.5, 6.1), discontinuation due to AEs (2.4, 2.8), herpes zoster (0.6, 0.7), malignancies (0.9, 0.9), major adverse cardiovascular events (0.3, 0.4), venous thromboembolism (0.1, 0.1), and deaths (0.3, 0.4). EAIRs/100 PYs were calculated as the number of patients with an AE over the total exposure time for all patients at risk.