Deucravacitinib delivers long-term efficacy in psoriatic arthritis

Treatment with deucravacitinib demonstrates its superiority to placebo across several endpoints in patients with psoriatic arthritis (PsA) at week 16, according to the phase III POETYK PsA-2 study. Clinical responses have also persisted for up to a year.

Furthermore, “[s]afety was consistent with the established deucravacitinib safety profile, [and] no new safety signals were identified,” said lead author Dr Philip J Mease, Providence Swedish Medical Center and University of Washington, Seattle, Washington, US, who presented the study at EADV 2025.

Mease and his team identified patients who met the CASPAR criteria and had a PsA diagnosis ≥3 months, active/documented history of plaque psoriasis, active arthritis (≥3 swollen/≥3 tender joints), and high-sensitivity C-reactive protein level ≥3 mg/L at screening. They randomized 729 patients to deucravacitinib 6 mg QD (n=312), placebo (n=312), or apremilast 30 mg BID (n=105) through week 16.

From week 16 to 52, patients on deucravacitinib or apremilast continued treatment, while those on placebo switched to deucravacitinib. The authors used multiplicity-controlled hierarchical testing to assess all endpoints. They also used nonresponder imputation for missing binary data and control-based pattern for missing continuous data. Safety was assessed through week 52.

ACR 20 at week 16 was the primary endpoint, while musculoskeletal system, skin, and PsA disease activity measures and quality of life (QoL) vs placebo were secondary endpoints.

Treatment groups had balanced patient demographics and disease characteristics at baseline. Significantly more patients in the deucravacitinib group achieved ACR 20 at week 16 than those in the placebo group (54.2 percent vs 39.4 percent; p=0.0002). Similar trends were noted for ACR 50 (28.8 percent vs 16.3 percent) and ACR 70 (10.6 percent vs 5.4 percent). [EADV 2025, abstract 4584]

“Response rates were maintained through week 52,” according to Mease and colleagues.

The proportion of patients who achieved the secondary endpoints were also significantly greater in the deucravacitinib than the placebo group (PASI 75: 40.9 percent vs 15.4 percent; p<0.0001; minimal disease activity: 25.6 percent vs 14.7 percent; p=0.0007).

Moreover, those treated with deucravacitinib demonstrated greater mean change from baseline in Health Assessment Questionnaire Disability Index (‒0.3246 vs ‒0.2120; p=0.0013) and Short Form-36 Physical Component Summary (5.838 vs 3.796; p=0.0002).

Resolution

In prespecified pooled analyses of the POETYK studies, deucravacitinib had higher resolution rates for enthesitis (50.3 percent vs 45.1 percent; p=0.1781) and dactylitis (57.6 percent vs 44.1 percent; p=0.0100) than placebo.

There was also a numerical improvement seen in FACIT-Fatigue score with deucravacitinib relative to placebo (2.5 vs 1.8; p=0.2017), while the mean change in DAS28-CRP from baseline was ‒1.2781 vs ‒0.8038 (p<0.0001).

Safety

The occurrence of serious adverse events (AEs) at week 16 was rare (deucravacitinib: 1.9 percent; placebo: 1.0 percent; apremilast: 3.8 percent), as was discontinuations due to AEs (2.2 percent, 1.3 percent, and 10.5 percent, respectively).

Notably, the use of deucravacitinib was well tolerated through week 52. The rates of major adverse cardiac events, venous thromboembolic events, opportunistic infections, and malignancies were similar with each treatment arm throughout the trial.

“Deucravacitinib is efficacious and well tolerated in PsA,” Mease said.

“Deucravacitinib, a first-in-class, oral, selective, allosteric TYK2 inhibitor, was investigated for PsA in the randomized, double-blind, phase III POETYK PsA-1 and POETYK PsA-2 trials,” he noted.