Study Highlights Laboratory Parameters in 4 Years of Psoriasis Treatment with Deucravacitinib

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There are no clinically meaningful mean changes or trends from baseline in the lipid, chemistry, or hematology parameters of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy involved in the POETYK PSO-1, PSO-2, and LTE studies, recent findings suggest.¹

The findings indicate that deucravacitinib use will not require routine laboratory testing among all psoriasis patients, contrasting with the noted requirements for janus kinase (JAK) 1, 2, and 3 inhibitors. These findings were presented as poster data at the Maui Derm NP+PA Fall 2024 conference in Nashville, with the study titled ‘Deucravacitinib in Plaque Psoriasis: Laboratory Parameters Through 4 Years of Treatment in the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials.’

The analysis of recent data was authored in part by Neil J. Korman, MD, PhD, professor of dermatology at University Hospitals Case Medical Center and the clinical director of the Murdough Family Center for Psoriasis. Korman et al. noted that the oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor was approved in the US and elsewhere for adults with moderate to severe psoriasis.²

Design and Findings

During the global, phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials lasting 52 weeks, investigators concluded that deucravacitinib was efficacious and well-tolerated when compared to both placebo and apremilast.2 The findings indicated greater cumulative benefits in terms of 75% reductions in their Psoriasis Area and Severity Index (PASI 75) scores and static Physician Global Assessment scores of 0 or 1 (sPGA 0/1).2

After the 52-week study period, subjects involved had been given the chance to sign up for the ongoing POETYK long-term extension (LTE; NCT04036435) study, during which they would be administered open-label deucravacitinib. During this extension study, the research team had concluded that shifts in participants’ blood laboratory parameters were typically linked with JAK 1, 2, and 3 inhibitors, and monitored through 4 years of deucravacitinib administration.

This study was noted as having assessed changes from baseline in liver function markers (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]). This was also true of subjects’ lipid levels (cholesterol and triglycerides) and other chemistry and hematology parameters including lymphocytes, creatine phosphokinase (CPK), neutrophils, creatine, hemoglobin, and platelets.

Participants had been evaluated through the 208-week mark, with investigators determining their data cutoff to be November 2023. In addition to laboratory parameters, investigators looked into treatment discontinuations resulting from abnormal lab results.

There were 1,519 subjects who were provided at least a single dose of deucravacitinib. This amounted to 4,392.8 person-years of treatment exposure, with 79.2% of these individuals finishing with 52 weeks of therapy at least.

A total of 35.7% subjects completed 208 weeks at least. The investigators noted a lack of major trends or substantial shifts from the point of baseline in any of the laboratory parameters evaluated here.

There had been a smaller number of participants who discontinued treatment given lab abnormalities such as elevated CPK levels, abnormal liver function, lymphopenia, and elevated ALT and AST. There were no treatment cessations due to increased triglycerides.

Overall, there were no clinically significant shifts in PSO-1/PSO-2/LTE from the point of baseline were observed in chemistry, hematology, lipid parameters, compared to the notable signature changes observed with use of JAK 1, 2 , and 3 inhibitors.

References

1. ^{Korman N, Passeron T, Stein Gold L, et al. ‘Deucravacitinib in Plaque Psoriasis: Laboratory Parameters Through 4 Years of Treatment in the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials.’ Poster data presented at Maui Derm NP+PA Fall 2024. Nashville, Tennessee. September 15-18.}
2. ^{Armstrong AW, Park SH, Patel V, et al. Cumulative Benefit Over 52 Weeks With Deucravacitinib Versus Apremilast in Moderate to Severe Plaque Psoriasis: POETYK PSO-1 Post Hoc Analysis. Dermatol Ther (Heidelb) (2024). https://doi.org/10.1007/s13555-024-01201-4.}