Deucravacitinib in Active Psoriatic Arthritis: Efficacy and Safety up to 52 Weeks From the Randomized, Double‐Blind, Phase 3 POETYK PsA‐2 Trial

OBJECTIVE: To assess the efficacy and safety of deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs or received tumor necrosis factor inhibitors. METHODS: In the 52-week (W), double-blind, placebo-controlled, phase 3 POETYK PsA-2 study (NCT04908189), patients were randomized 3:3:1 to deucravacitinib 6 mg daily, placebo, or apremilast 30 mg twice daily (safety reference arm) through W16. From W16 to W52, patients continued receiving deucravacitinib or apremilast or switched from placebo to deucravacitinib. The primary endpoint was American College of Rheumatology 20% improvement in response (ACR20) at W16. Secondary endpoints were analyzed per prespecified order to control for multiplicity. RESULTS: Overall, 729 patients were randomized (312 deucravacitinib, 312 placebo, 105 apremilast). Significantly more patients achieved ACR20 at W16 with deucravacitinib versus placebo (54.2% vs 39.4%; P=0.0002); responses improved beyond W16 and were maintained through W52 (deucravacitinib-deucravacitinib, 62.2%; placebo-deucravacitinib, 67.3%). At W16, significant differences with deucravacitinib versus placebo were observed in hierarchal secondary endpoints of HAQ-DI, PASI-75, SF-36 PCS, and achievement of MDA. At W16, serious adverse events occurred in 1.0%, 1.9%, and 3.8% of patients with placebo, deucravacitinib, and apremilast, respectively. No new safety signals, deaths, or imbalances in cardiovascular events, malignancies, or opportunistic infections occurred through W52. CONCLUSION: Deucravacitinib was well-tolerated in patients with PsA and demonstrated superior efficacy versus placebo across multiple clinical endpoints and patient-reported outcomes, including functional ability and quality of life. Clinical responses and patient-reported outcomes were maintained through week 52.