New 5-Year Data Show Stability of Deucravacitinib Safety for Those with Psoriasis

Mark G. Lebwohl, MD

Credit: Vitiligo Research Foundation

In a new announcement by Bristol Myers Squibb, 5-year results from the POETYK PSO long-term extension (LTE) trial demonstrating the durable safety profile of deucravacitinib (Sotyktu) for adults with moderate-to-severe plaque psoriasis have been released.¹

The February 16 announcement highlights over 5,000 patient years of exposure to deucravacitinib and a complete lack of new safety concerns emerging over the extension trial among patients with psoriasis. The inflammatory skin disease is known to affect close to 100 million individuals worldwide, with many patients with moderate-to-severe disease being undertreated despite the availability of effective systemic treatment options.

“Today’s findings demonstrate the continued long-term safety and efficacy profile of [deucravacitinib], with patients maintaining skin clearance over five years,” Mark Lebwohl, MD, dean of Clinical Therapeutics at the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai and investigator and paid consultant for Bristol Myers Squibb, said in a statement. “These results further support the role of [deucravacitinib] , the first TYK2 inhibitor available for patients living with moderate-to-severe plaque psoriasis, as a potential oral standard of care.”¹

Deucravacitinib itself is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor and is the first selective TYK2 inhibitor in clinical research across multiple immune-mediated conditions, maintaining a unique mechanism of action. It was formulated to target TYK2 selectively, thus inhibiting interleukin (IL)-23, IL-12, and Type 1 interferons (IFN).

The phase 3 POETYK PSO-1 and POETYK PSO-2 studies were a set of global clinical trials designed to assess the efficacy and safety of deucravacitinib compared to placebo and apremilast (Otezla).² Each trial enrolled 666 and 1,020 subjects, respectively, with both studies structured as multicenter, randomized, double-blind studies.

Participants in the studies were either treated with deucravacitinib at a 6 mg daily dose, with a placebo, or with 30 mg apremilast twice-per-day. In POETYK PSO-2, there had been a randomized withdrawal phase and a retreatment phase after the 24-week mark.

In both of the studies, investigators found that a significantly higher percentage of individuals in the deucravacitinib treatment arm achieved Psoriasis Area and Severity Index (PASI) 75, PASI 90, and static Physician’s Global Assessment (sPGA) 0/1 responses as opposed to those in the placebo or apremilast arms.

Sustenance of these responses among patients occurred through the 52-week mark, with 82% of the subjects attaining PASI 75 at the 24-week mark in POETYK PSO-1 maintaining their response at 52 weeks. For those in POETYK PSO-2, 80% of the subjects who continued deucravacitinib therapy were shown by the investigators to have maintained PASI 75 at the 52-week mark, as opposed to only 31% of those who had withdrawn from the medication.¹

Following these 2 studies, participants had been given option to take part in the ongoing POETYK PSO-LTE study, during which these participants were given open-label deucravacitinib (6 mg once-per-day). There were 1,221 individuals who took part in the trial and were provided with at least a single dose of the drug in the extension.¹

The research team implemented the treatment failure rules (TFR) method for imputation in their assessments, making additional sensitivity analyses through the use of modified non-responder imputation and as-observed analysis. Overall, it was reported that subjects in the long-term extension who were provided with continuous deucravacitinib maintained their clinical responses from the first year through to Year 5.¹

Specifically, the POETYK-PSO-LTE investigators highlighted sustained rates of sPGA 0/1, PASI 75, and PASI 90, presenting the data at the 2025 Winter Clinical Dermatology Conference in Hawaii.

Consistent efficacy in the long term remained consistent among individuals who continued on the medication, the team concluded. They found that 72.1% of subjects at the 1-year mark attained PASI 75, as opposed to 67.3% at the 5-year mark. Additionally, the investigators highlighted rates of PASI 90 rates which had been 45.9% at the 1-year mark and 46.3% at the 5-year mark, as well as sPGA 0/1 observed in 57.5% and 52.6% at Year 1 and 5, respectively.¹

References

1. New Five-Year Sotyktu (deucravacitinib) Data Show Consistent Safety and Durable Response Rates in Moderate-to-Severe Plaque Psoriasis. Bristol Myers Squibb. February 16, 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. Date accessed: February 17, 2025.

2. Armstrong A. POETYK PSO-1 and POETYK PSO-2 Trials for Plaque Psoriasis. HCPLive. March 13, 2024. https://www.hcplive.com/view/poetyk-pso-1-and-poetyk-pso-2-trials-for-plaque-psoriasis. Date accessed: February 16, 2025.