Results from Phase 2 PoS Trial
In patients with active psoriatic arthritis (PsA) , deucravacitinib was efficacious versus placebo (PBO) over 16 weeks of treatment. Treatment was well tolerated and the safety profile was consistent with that of the previous Phase 2 plaque psoriasis (PsO) trial.
In the previous trial, 67%–75% of patients with PsO who received deucravacitinib ≥3 mg twice daily achieved PASI 75 at 12 weeks versus 7% for PBO. No serious adverse events (AEs) were observed.
Results of this trial were recently presented at ACR Convergence 2020.
This is an ongoing, 1-year, randomized, double-blind, PBO-controlled, multicenter trial. Eligible patients had a PsA diagnosis for ≥6 months, met CASPAR criteria, and had active disease, C‑reactive protein ≥3 mg/L, and ≥1 psoriatic lesion. Patients had failed or were intolerant (IR) to ≥1 nonsteroidal anti-inflammatory drug, corticosteroid, and/or conventional synthetic disease-modifying antirheumatic drug (csDMARD), or 1 TNF inhibitor (TNFi).
Subjects were randomized 1:1:1 to deucravacitinib 6 mg once daily (QD) or 12 mg QD, or PBO. The primary endpoint was ACR 20 response at week 16. Key secondary endpoints included improvement from baseline in the HAQ-DI and SF-36 PCS. Additional endpoints included the proportion of patients achieving ACR 50/70, HAQ-DI response (≥0.35 improvement from baseline), minimal disease activity, enthesitis resolution (Leeds Index), and AEs.
Of 203 patients randomized, 180 (89%) completed 16 weeks of treatment. Demographic and baseline disease characteristics were similar across the three groups. The median PsA duration was 4.5 years, 66% of patients were using csDMARDs at baseline, and 15% were TNFi-IR.
The study met its primary objective of showing a dose-response relationship, with both deucravacitinib 6 mg (n=70) and 12 mg QD (n=67) demonstrating significantly greater ACR 20 responses versus PBO (n=66) at week 16 (52.9% and 62.7% versus 31.8%, respectively).
Key secondary objectives were achieved with significant and generally similar improvements in secondary endpoints for both deucravacitinib doses versus PBO.