Deucravacitinib Long-term Efficacy With Continuous Treatment in Plaque Psoriasis: 2-Year Results From the Phase 3 POETYK PSO-1 and PSO-2 Trials

Abstract

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib treatment was superior to placebo and apremilast in the POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials in moderate to severe plaque psoriasis. We evaluated long-term clinical outcomes in patients with ≈2 years (112 weeks) of continuous deucravacitinib exposure.
 Methods: PSO-1 and PSO-2 patients were randomized 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. At Week 52, patients were eligible to enroll in the POETYK long-term extension (LTE; NCT04036435) trial and receive deucravacitinib 6 mg once daily. Efficacy outcomes included ≥75%/≥90% reduction from baseline in Psoriasis Area and Severity Index (PASI 75/90) and static Physician Global Assessment score of 0 (clear) or 1 (almost clear) with a ≥2-point improvement from baseline (sPGA 0/1). Efficacy was assessed using modified nonresponder imputation through the data cutoff date of October 1, 2021 (Week 112) in patients receiving continuous deucravacitinib treatment from Day 1 and in patients receiving continuous deucravacitinib treatment who achieved PASI 75 at Week 24. As-observed data and results by treatment failure rules imputation were also analyzed.
 Results: A total of 513 patients received continuous deucravacitinib from Day 1 in PSO-1/PSO-2 until Week 112 in the LTE, including 336 patients who had achieved PASI 75 at Week 24. High clinical response rates achieved at Week 52 in PSO-1/PSO-2 (PASI 75, 73.0%; PASI 90, 46.3%; sPGA 0/1, 58.5%) were maintained at Week 112 in the LTE (PASI 75, 76.2%; PASI 90, 48.3%; sPGA 0/1, 58.4%) among patients receiving continuous deucravacitinib treatment from Day 1. High response rates were also maintained in Week 24 PASI 75 responders (Week 52: PASI 75, 90.3%: PASI 90, 62.1%: sPGA 0/1, 73.8%; Week 112: PASI 75, 89.2%; PASI 90, 61.1%; sPGA 0/1, 70.5%). Results were consistent regardless of data imputation methodology.
 Conclusion: Deucravacitinib was associated with sustained efficacy through 2 years in patients who received continuous treatment from Day 1 and in patients who achieved PASI 75 at Week 24. High clinical response rates achieved at Week 52 were maintained at Week 112. These findings provide additional support for deucravacitinib as an efficacious long-term treatment for moderate to severe plaque psoriasis.