Phase III POETYK PsA-1 trial: Deucravacitinib in PsA

Results from the multicenter, randomized, double-blind, placebo-controlled, phase III POETYK PsA-1 (NCT04908202) trial evaluating deucravacitinib in 670 adults with active psoriatic arthritis (PsA) who were naïve to biologic disease-modifying antirheumatic drugs (bDMARDs) were published in the Annals of the Rheumatic Diseases by van der Heijde et al. The primary endpoint was American College of Rheumatology 20% improvement in response (ACR20) at Week 16.  

Key data: At Week 16, the ACR20 response rate was higher with deucravacitinib vs placebo (54.2% vs 34.1%; p < 0.001). ACR20 response rates increased through Week 52 in patients who received deucravacitinib throughout the study (63.1%) and in those who switched from placebo to deucravacitinib at Week 16 (60.8%). At Week 16, response rates for ≥75% improvement in Psoriasis Area and Severity Index (PASI75; 51.9% vs 7.1%; p < 0.001) and minimal disease activity (MDA; 19.0% vs 10.2%; p = 0.001) were higher with deucravacitinib vs placebo. In post hoc analyses, radiographic progression was lower with deucravacitinib vs placebo at Week 16 (rank analysis of covariance [ANCOVA], p = 0.009 in the full population). Rates of serious adverse events (SAEs) were comparable between deucravacitinib and placebo at Week 16 (1.8% vs 2.4%) and remained similar through Week 52 between patients who received continuous deucravacitinib and those who switched from placebo at Week 16 (exposure-adjusted incidence rate [EAIR], 8.9 vs 9.0 per 100 patient-years, respectively). No new safety signals related to major adverse cardiac events (MACE), venous thromboembolism (VTE), malignancies, or opportunistic infections were reported. 

Key learning: Deucravacitinib demonstrated greater clinical responses than placebo across multiple PsA domains at Week 16, with responses maintained through Week 52 and no new safety signals identified in patients who were bDMARD-naïve.