POETYK PsA-1: Deucravacitinib in Biologic-Naïve PsA Save

Know-it-now

POETYK PsA-1 trial tested the disease modifying efficacy of deucravacitinib, a tyrosine kinase 2  (TYK2) inhibitor, in psoriatic arthritis (PsA) patients and was shown to be superior vs to placebo for clinical responses, patient-reported outcomes, and structural damage inhibition in PsA. 

This was a multicentre, randomised, double-blind, placebo-controlled phase 3 trial (186 sites, 21 countries) that tested deucravacitinib 6 mg once daily vs. placebo in biologic-naïve patients with active PsA.  Patients had to hav active disease (hsCRP ≥3 mg/L, active joints), and ≥1 PsA-related hand/foot erosion on radiograph. After 16 weeks of blinded therapy, placebo patients switched to deucravacitinib through Week 52. Primary endpoint: ACR20 at W16, with nonresponder imputation. 

A total of 670 PsA patients were randomised; 82% completed 52 weeks. Mean disease duration was 7.7 years; 70% were on csDMARDs at baseline (58.5% methotrexate); 38.5% had hsCRP ≥10 mg/L. The study was moderately treatment-experienced, with more csDMARD-inadequate-response than treatment-naïve patients.  The ACR20 at W16 was 54% on deucravacitinib vs 34% on placebo (P < .001). 

Key secondary endpoints benefits were seen in skin, musculoskeletal, and composite disease-activity domains were also met.  Patients initially treated with placebo continued to numerically increase benefits through Week 52. 

Radiographic structural damage inhibition was demonstrated at both W16 and W52.

Safety outcomes were favorable with low numbers of serious adverse events (AEs)- 1.8% (deucravacitinib) vs 2.4% (placebo). Discontinuations due to AEs were also similar (2.4% vs 1.8%). No imbalance in MACE, malignancy, or opportunistic infection, or deaths were observed.