Deucravacitinib: Laboratory Parameters Across Phase 3 Plaque Psoriasis Trials.

Abstract

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the USA and other countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. In POETYK PSO-1 and PSO-2, deucravacitinib was superior to placebo and apremilast and well tolerated in patients with plaque psoriasis. Patients who completed PSO-1/PSO-2 could enroll in the POETYK long-term extension (LTE) trial. This analysis evaluates the effects of deucravacitinib on laboratory parameters.

Methods: POETYK PSO-1 and PSO-2 were 52-week, phase 3, double-blinded trials that randomized patients 1:2:1 to placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. At week 52, eligible patients enrolled in POETYK LTE and received open-label deucravacitinib. Mean changes from baseline in laboratory parameters, laboratory adverse events (AEs), and laboratory AEs resulting in discontinuation were evaluated over 3 years.

Results: A total of 1519 patients received one or more doses of deucravacitinib across trials. Total exposure over 3 years was 3294.3 person-years. No clinically relevant mean changes were observed in laboratory parameters. Grade ≥ 3 laboratory AEs were infrequent during the 1-year period, with incidence rates remaining stable in patients treated with deucravacitinib through 3 years. Most laboratory AEs remained at the same grade; shifts to higher grades were infrequent, with most increases being to grade ≤ 2. Discontinuations due to laboratory AEs were rare.

Conclusions: Deucravacitinib did not result in clinically meaningful changes in laboratory parameters over 3 years, including changes seen with Janus kinase (JAK) 1,2,3 inhibitors. Grade ≥ 3 laboratory AEs and discontinuations were rare.

Trial registration: ClinicalTrials.gov identifier, POETYK PSO-1 (NCT03624127), POETYK PSO-2 (NCT03611751), POETYK LTE (NCT04036435).