Bristol Myers Squibb has released five-year data from the POETYK PSO long-term extension (LTE) trial, showing the sustained safety and efficacy of deucravacitinib (Sotyktu) for adults with moderate-to-severe plaque psoriasis. The findings, announced on February 16, highlight over 5,000 patient years of exposure to the drug, with no new safety concerns emerging during the trial.
Psoriasis, an inflammatory skin condition, affects approximately 100 million people globally. Despite the availability of effective systemic treatments, many patients with moderate-to-severe forms of the disease remain undertreated.
Mark Lebwohl, MD, Dean of Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai, emphasized the significance of the findings. “These results further support the role of deucravacitinib as a potential oral standard of care for patients living with moderate-to-severe plaque psoriasis,” he said. “Patients have maintained skin clearance over five years, demonstrating the continued long-term safety and efficacy of this treatment.”
Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, the first of its kind in clinical research across multiple immune-mediated conditions. The drug targets TYK2 selectively to inhibit interleukin (IL)-23, IL-12, and Type 1 interferons (IFN), key players in psoriasis.
The phase 3 POETYK PSO-1 and POETYK PSO-2 studies compared deucravacitinib with placebo and apremilast (Otezla) to assess the drug’s safety and efficacy. Both studies were randomized, double-blind, and multicenter trials. In these trials, participants were administered either 6 mg of deucravacitinib daily, a placebo, or 30 mg of apremilast twice daily.
Results showed that a higher percentage of patients in the deucravacitinib group achieved significant clinical responses—PASI 75, PASI 90, and static Physician’s Global Assessment (sPGA) 0/1—compared to those in the placebo or apremilast groups. These responses were maintained over 52 weeks, with 82% of patients in the POETYK PSO-1 trial maintaining PASI 75 at 52 weeks, and 80% of patients in POETYK PSO-2 who continued on deucravacitinib showing sustained PASI 75 at the 52-week mark.
After completing the initial studies, participants were invited to join the ongoing POETYK PSO-LTE study. A total of 1,221 patients were enrolled, continuing to receive deucravacitinib (6 mg daily) in an open-label extension. The results showed that patients who continued treatment with deucravacitinib maintained their clinical responses through the fifth year.
At the 1-year mark, 72.1% of participants achieved PASI 75, and 45.9% achieved PASI 90. At Year 5, these numbers were 67.3% and 46.3%, respectively. Similarly, the percentage of patients with sPGA 0/1 was 57.5% at Year 1 and 52.6% at Year 5. The investigators concluded that the long-term efficacy of deucravacitinib remained consistent throughout the five-year period.
The findings were presented at the 2025 Winter Clinical Dermatology Conference in Hawaii, underscoring the drug’s sustained safety and efficacy profile for individuals with moderate-to-severe plaque psoriasis.
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