Efficacy and Safety of Deucravacitinib in Patients With Plaque Psoriasis
abstract
This abstract is available on the publisher's site.
Access this abstract nowBACKGROUND
In the phase 3 POETYK PSO-1 and PSO-2 trials, deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, was well-tolerated and efficacious over 1 year in patients with psoriasis.
OBJECTIVE
Evaluate deucravacitinib safety and efficacy over 2 years in patients participating in the phase 3 trials.
METHODS
In the POETYK long-term extension (LTE), an ongoing, phase 3b, open-label trial, adults with moderate to severe plaque psoriasis who completed PSO-1 or PSO-2 receive deucravacitinib 6 mg once daily. Safety was assessed via adverse events (AEs) and laboratory parameter abnormalities. Efficacy endpoints, including ≥75% reduction from baseline in the Psoriasis Area and Severity Index (PASI 75) and static Physician Global Assessment (sPGA) score of 0/1 (clear/almost clear), were evaluated in patients originally randomized to deucravacitinib, patients crossing over from placebo at Week 16, and patients achieving PASI 75 at Week 24 (peak efficacy).
RESULTS
At data cutoff (October 1, 2021), 1519 patients had received ≥1 dose of deucravacitinib; 79.0% and 39.9% had ≥52 weeks and ≥104 weeks, respectively, of total deucravacitinib exposure. Exposure-adjusted incidence rates (EAIRs) per 100 person-years were similar at 1 year and 2 years, respectively, for any AEs (229.2 vs 154.4), serious AEs (5.7 vs 6.1), discontinuations (4.4 vs 2.8), deaths (0.2 vs 0.4), serious infections (1.7 vs 2.6), herpes zoster (0.9 vs 0.8), major adverse cardiovascular events (0.3 vs 0.4), venous thromboembolic events (0.2 vs 0.1), and malignancies (1.0 vs 0.9). EAIRs for COVID-19 infections were higher at 2 years than at 1 year (5.1 vs 0.5) due to the peak of the global COVID-19 pandemic occurring during the LTE. No clinically meaningful changes from baseline or trends were observed over 2 years in haematologic, chemistry, or lipid parameters. Clinical responses were maintained in patients receiving continuous deucravacitinib treatment from baseline (PASI 75: Week 52, 72.4%; Week 112, 79.7%; sPGA 0/1: Week 52, 57.9%; Week 112, 61.1% [as observed]). Responses at Week 52 were also maintained in placebo crossovers and in Week 24 PASI 75 responders.
CONCLUSIONS
Deucravacitinib maintained efficacy and demonstrated consistent safety with no new safety signals observed through 2 years. (ClinicalTrials.gov identifier: NCT04036435).
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Additional Info
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Deucravacitinib in plaque psoriasis: 2-year safety and efficacy results from the phase 3 poetyk trials
Br J Dermatol 2024 Jan 16;[EPub Ahead of Print], M Lebwohl, RB Warren, H Sofen, S Imafuku, C Paul, JC Szepietowski, L Spelman, T Passeron, E Vritzali, A Napoli, RM Kisa, A Buck, S Banerjee, D Thaçi, A BlauveltFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Plaque psoriasis is a chronic inflammatory skin condition, with pervasive systemic effects that impair the quality of life. Lebwohl et al evaluated the use of deucravacitinib, an oral allosteric tyrosine kinase 2 inhibitor, in treating patients with moderate to severe plaque psoriasis over a 2-year period. A consistent safety profile was observed when compared with the previous 1-year study. Furthermore, both efficacy and tolerability were maintained throughout the 2-year period. The exposure-adjusted incidence rates (EAIRs) for adverse events, serious adverse events, discontinuations, deaths, serious infections, herpes zoster, major adverse cardiovascular events, venous thromboembolic events, and malignancies were comparable at 1 and 2 years. The most reported adverse events over the 2 years were nasopharyngitis (EAIR, 12.9/100 person-years), upper respiratory tract infections (EAIR, 6.5/100 person-years), and COVID-19 (EAIR, 5.1/100 person-years). All EAIRs, except those for COVID-19 infections, were lower at 2 years than at 1 year, citing peak numbers during the global pandemic.
Overall, this study demonstrated consistent results at 2 years when compared with the shorter 1-year study, with no emergence of new safety signals reported. The limitations in both studies included a patient population predominantly involving males (67.5%) and White individuals (87.2%). Consequently, these demographics may lead to limited insights into the long-term effects of deucravacitinib in females and individuals of other races and ethnicities.