Five-Year POETYK PSO Trial Results Show Sustained Efficacy, Safety with Sotyktu for Moderate-to-Severe Plaque Psoriasis

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Newly released five-year data from the POETYK PSO long-term extension (LTE) trial show sustained efficacy and safety with Sotyktu (deucravacitinib) in the treatment of moderate-to-severe plaque psoriasis.¹ The latest results follow up on four-data that showed seven in 10 adults with moderate-to-severe plaque psoriasis administered Sotyktu were able to maintain a clinical response in the Psoriasis Area and Severity Index (PASI) 75.² 

The results indicate that Sotyktu, an oral, selective, allosteric tyrosine kinase 2 inhibitor, limits cytokine signaling in psoriasis pathogenesis, could fill a significant unmet need for this patient population.³

“[The] findings demonstrate the continued long-term safety and efficacy profile of Sotyktu, 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 an investigator and paid consultant for Bristol Myers Squibb. “These results further support the role of Sotyktu, the first TYK2 inhibitor available for patients living with moderate-to-severe plaque psoriasis, as a potential oral standard of care.”¹

The global, multicenter, randomized, double-blind Phase III PrOgram to Evaluate the efficacy and safety of Sotyktu (POETYK) trials included PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751). The trials were designed to compare the efficacy of Sotyktu vs. placebo and Otezla (apremilast), and to assess the safety of Sotyktu in patients with moderate-to-severe plaque psoriasis. POETYK PSO-1 enrolled 666 patients, whereas POETYK PSO-2 enrolled 1,020 patients to receive Sotyktu at a dose of 6 mg once daily to compare with placebo and Otezla at a dose of 30 mg twice daily.

For both POETYK PSO-1 and PSO-2, the co-primary endpoints were percentage of patients achieving a PASI 75 response and patients achieving static Physician's Global Assessment (sPGA) score of 0 or 1 (clear/almost clear) at week 16 compared with placebo. The trials’ key secondary endpoints included percentage of patients achieving PASI 75 and sPGA 0/1 vs. Otezla at week 16.

Investigators found that patients continuously treated with Sotyktu maintained clinical response rates from year one to year five, with PASI 75, PASI 90, and static Physician’s Global Assessment (sPGA) 0/1 (clear/almost clear). The results show that Sotyktu for PASI 75 was 72.1% at year one and 67.3% at year five, for PASI 90 was 45.9% at year one and 46.3% at year five, and sPGA 0/1 was 57.5% at year one and 52.6% at year five.

These findings included 513 patients administered continuous Sotyktu from day one of the POETYK PSO-1 and PSO-2 trials who transitioned to the POETYK PSO-LTE trial. The safety findings included 1,519 patients administered at least one dose of Sotyktu in the POETYK trial program. Patients in the five-year LTE finished 256 weeks of therapy, with efficacy evaluated via modified nonresponder imputation method.

“These positive five-year results build upon the established profile of Sotyktu , a first-in-class TYK2 inhibitor, as a transformative oral treatment for psoriasis,” said Edgar Charles, MD, vice president and senior global program lead, Early & Late Development Immunology, Bristol Myers Squibb. “As the leader in TYK2 innovation, we continue our relentless pursuit of bold science to elevate new standards of care for the patients we serve.”¹

References

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. February 16, 2025. Accessed February 17, 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

2. New Four-Year Sotyktu (deucravacitinib) Data Demonstrate Durable Response Rates and Consistent Safety in Moderate-to-Severe Plaque Psoriasis. News release. Bristol Myers Squibb. May 17, 2024. Accessed February 17, 2025. https://news.bms.com/news/corporate-financial/2024/New-Four-Year-Sotyktu-deucravacitinib-Data-Demonstrate-Durable-Response-Rates-and-Consistent-Safety-in-Moderate-to-Severe-Plaque-Psoriasis/default.aspx

3. Strober, B. et al. (2023) “Deucravacitinib versus Placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 program for evaluation of TYK2 inhibitor psoriasis second trial,” Journal of the American Academy of Dermatology, 88(1), pp. 40–51. Available at https://doi.org/10.1016/j.jaad.2022.08.061.