Edgar Charles, MD, on Long-term Deucravacitinib Psoriasis Data

Earlier this month, Bristol Myers Squibb presented new 5-year data from the POETYK PSO long-term extension (LTE) trial evaluating the safety and efficacy of deucravacitinib (Sotyktu) in adults with moderate to severe plaque psoriasis. The findings, presented at the 2025 Winter Clinical Hawaii Conference, confirm that deucravacitinib maintains a consistent safety profile with no new safety signals identified over 5 years and sustains clinical efficacy outcomes.¹

In light of this emerging data, Dermatology Times spoke with Edgar Charles, MD, vice president and senior global program lead, Early/Late Development Immunology, Bristol Myers Squibb, for insight into what this means for the greater psoriasis community.

Q&A

Dermatology Times: What were the key findings of the 5-year POETYK PSO LTE trial?

Charles: The key findings of the 5-year POETYK PSO long-term extension (LTE) trial are 2-fold. First, the safety profile of [deucravacitinib] remained consistent throughout the duration of the LTE trial. Second, efficacy was maintained across multiple important clinical response rates, including Psoriasis Area and Severity Index (PASI) 75, PASI 90 and static Physician’s Global Assessment (sPGA) 0/1, for patients who received continuous [deucravacitinib] treatment through five years.

DT: How do the 5-year results compare to the initial 1-year findings?

Charles: These results contribute to the consistently positive results we have observed throughout the long-term extension trial, dating back to year 1. Exposure-adjusted incidence rates of adverse events remained generally consistent at 5 years when compared to rates observed at the completion of the controlled clinical trials at 1 year. Efficacy achieved during the controlled trial was also maintained through 5 years. Importantly, with these 5-year results, we now have more than 5,000 patient years of exposure, with no new safety signals identified, which reflects a significant amount of time to demonstrate the consistency of the established safety profile of [deucravacitinib].

DT: How do you see these long-term data influencing physician confidence in prescribing deucravacitinib?

Charles: One of the most important aspects of these 5-year results from the POETYK PSO long-term extension trial is that they continue to support the consistent safety and durable efficacy profile of [deucravacitinib] for adults with moderatetosevere plaque psoriasis. As a result, these data show the important role[deucravacitinib] can play as a potential oral standard of care.

DT: How does the success of deucravacitinib in psoriasis influence research into TYK2 inhibition for other conditions?

Charles: BMS’ in-house knowledge and research continue to advance our understanding of the science behind TYK2 inhibition. As a result, [deucravacitinib] is the first selective TYK2 inhibitor in clinical studies across several immune-mediated diseases. We recently announced positive topline results from phase 3 trials for [deucravacitinib] in adults with active psoriatic arthritis, and it is currently in phase 3 trials for systemic lupus erythematosus (SLE) and Sjögren’s disease.

DT: Any additional thoughts or insights?

Charles: What is most important for clinicians to know is that the safety profile of [deucravacitinib], an oral therapy, remained consistent through 5 years with more than 5,000 patient years of exposure. There were no increases in adverse event rates or serious adverse event rates over time and no emergence of any new safety signals, continuing the demonstration of a differentiated safety profile. Clinical response rates were maintainedthrough5 years in more than 500 patients who were treated continuously with [deucravacitinib] from the beginning of the phase 3 parent trials.

Reference

1. New five-year sotyktu (deucravacitinib) data show consistent safety and durable response rates in moderate-to-severe plaque psoriasis. News release. Bristol Myers Squibb. Published February 16, 2025. Accessed February 27, 2025. https://news.bms.com/news/corporate-financial/2025/New-Five-Year-Sotyktu-deucravacitinib-Data-Show-Consistent-Safety-and-Durable-Response-Rates-in-Moderate-to-Severe-Plaque-Psoriasis/default.aspx