Deucravacitinib in Moderate to Severe Plaque Psoriasis: Comorbidities and Use of Prior and Concomitant Medication in Patients Enrolled in 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 treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was superior to placebo and apremilast in two global, phase 3 trials, POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751), in moderate to severe plaque psoriasis. Here, we evaluate the comorbidities present at baseline and use of prior and concomitant medications in the pooled POETYK PSO-1 and PSO-2 trial populations to more comprehensively describe the medical history of individuals who participated in the deucravacitinib phase 3 trials. Methods: In POETYK PSO-1 and PSO-2, adults with moderate to severe plaque psoriasis were randomized 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. The rates of baseline comorbidities and medications received before and concomitantly with deucravacitinib in the pooled POETYK PSO trials were assessed. Medication classes evaluated included antidiabetic, antihypertensive and cardiovascular, lipid-reducing, anti-anxiety/depression, and oral contraceptive therapies. Results: Baseline patient demographics were similar across treatment arms. Metabolism and nutrition disorders were reported most often in each treatment arm (placebo, 42.7%; deucravacitinib, 39.2%; apremilast, 38.4%), followed by vascular disorders (33.7%, 34.9%, and 31.8%, respectively). Hypertension was the most common baseline medical condition (placebo, 30.3%, deucravacitinib, 32.8%, and apremilast, 29.1%), with obesity, hyperlipidemia, type 2 diabetes mellitus, and seasonal allergies each reported in 10% to 12% of patients in at least one treatment arm. Antihypertensive and cardiovascular agents, lipid-reducing agents, and antidiabetic agents were the most commonly reported medications. Conclusion: The phase 3 POETYK PSO trials enrolled adults with moderate to severe plaque psoriasis with a range of comorbidities consistent with the real-world population of patients with psoriasis. Medication classes used by patients were consistent with the comorbidities reported at baseline in both trials.