Long-Term Efficacy and Safety of Deucravacitinib in Moderate-to-Severe Plaque Psoriasis

The phase 3 POETYK PSO-1 and PSO-2 trials demonstrated that deucravacitinib, an oral selective allosteric tyrosine kinase 2 (TYK2) inhibitor, was both well tolerated and effective for patients with moderate-to-severe psoriasis during a 1-year period. A recent long-term extension (LTE) study was conducted to evaluate the safety and efficacy of deucravacitinib over 2 years in patients who completed the initial trials. This LTE study provides further data on the long-term use of deucravacitinib in treating psoriasis.

Given the chronic nature of psoriasis, it is essential to assess the long-term safety and efficacy of treatments. Previous studies, including the PSO-1 and PSO-2 trials, demonstrated the short-term benefits of deucravacitinib. The LTE was designed to extend these observations and determine whether the therapeutic effects and safety profile remain favorable over a longer duration of use.

In this ongoing phase 3b open-label LTE trial, adults with moderate-to-severe plaque psoriasis who completed the PSO-1 or PSO-2 trials were enrolled and received 6 mg of deucravacitinib daily. Safety was assessed through adverse events (AEs) and laboratory parameter abnormalities. Efficacy was measured by achieving a ≥ 75% reduction in the Psoriasis Area and Severity Index (PASI 75) score and a static Physician's Global Assessment (sPGA) score of 0/1 (clear/almost clear). These efficacy measures were evaluated at weeks 52 and 112 for patients originally randomized to deucravacitinib, those who crossed over from placebo, and those who achieved PASI 75 at week 24.

At the data cutoff on October 1, 2021, 1519 patients had received at least one dose of deucravacitinib, with 79% having received at least 52 weeks of treatment, and 39.9% having been treated for more than 2 years. The exposure-adjusted incidence rates (EAIRs) of any AEs, serious AEs, and other safety outcomes were comparable between the 1-year and 2-year time points. EAIRs for COVID-19 infections were higher at 2 years than at 1 year, likely due to the peak of the global COVID-19 pandemic occurring during the LTE. No clinically meaningful changes were observed in hematological, chemistry, or lipid parameters over the 2 years. Efficacy was maintained in patients who received continuous treatment from baseline, with 72.4% achieving PASI 75 at week 52 and 79.7% at week 112. Similarly, 57.9% had a sPGA score of 0/1 at week 52, increasing to 61.1% by week 112.

‘Deucravacitinib maintained efficacy and demonstrated consistent safety with no new safety signals observed through 2 years,” the study authors concluded.

Reference

Lebwohl M, Warren RB, Sofen H, et al. Deucravacitinib in plaque psoriasis: 2-year safety and efficacy results from the phase III POETYK trials. Br J Dermatol. 2024;190(5):668-679. doi:10.1093/bjd/ljae014