POETYK PsA-1: First results up to Week 16 of deucravacitinib vs placebo in patients with active PSA

Deucravacitinib is approved in multiple countries for psoriasis and has demonstrated efficacy in moderate-to-severe plaque psoriasis. Deucravacitinib is a first-in-class oral selective TYK2 inhibitor under investigation in phase III POETYK PsA-1 (NCT04908202) and PEOTYK PsA-2 (NCT04908189) trials. 

During the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress, Désirée van der Heijde presented the first results up to Week 16 from the POETYK PsA-1 trial, assessing the efficacy and safety of deucravacitinib in bDMARD-naïve adult patients with active PsA.¹

Patients with active PsA, defined by ≥3 swollen or tender joints, hsCRP ≥3 mg/L, and ≥1 PSA-related hand or foot erosion on radiographs, and no prior use of bDMARDs, were included (N = 670). Eligible patients were randomized 1:1 to receive either deucravacitinib 6 mg QD (n = 336) or placebo (n = 334). The primary endpoint was ACR 20. Key secondary endpoints included PASI 75, MDA, enthesitis and dactylitis resolution, and change from baseline in HAQ-DI, SF-36 PCS, mSvdH, FACIT-Fatigue, and DAS28-CRP.

Key learnings

The primary endpoint of ACR 20 at Week 16 was met; ACR 20 was achieved by 54.2% vs 34.1% of patients in the deucravacitinib vs placebo arms, respectively (p < 0.0001).

Deucravacitinib produced greater changes from baseline in HAQ-DI (-0.39 vs -0.22; p < 0.0001), SF-36 PCS (6.06 vs 3.71; p < 0.0001), FACIT-Fatigue (4.6 vs 2.0; p < 0.0001), and DAS-28 CRP scores (-1.33 vs -0.83; p < 0.0001) vs placebo.

Patients receiving deucravacitinib achieved higher rates of PASI 75 (51.9% vs 7.1%; p < 0.0001) and MDA (19.0% vs 10.2%; p = 0.0012) vs those receiving placebo.

Pooled analysis of PsA 1 and PsA-2 trials using the SPARCC index showed deucravacitinib achieved higher resolution of enthesitis (47.1% vs 36.1%; p = 0.0018) and dactylitis (57.6% vs 44.1%; p = 0.0100) vs placebo. 

Post hoc radiographic analyses showed deucravacitinib vs placebo achieved a lower change from baseline in mSvdH total score in the prespecified population (0.41 vs 0.50; p = 0.0187), as well as the full population (0.37 vs 0.60; p = 0.0090).

No new safety signals were observed; AEs were consistent with the known safety profile of deucravacitinib. SAEs were reported in 2.4% vs 1.8% of patients in the deucravacitinib vs placebo arms, respectively.

Deucravacitinib was effective and well-tolerated in patients with active PsA and offers a promising oral therapeutic option.