5-Year Study Backs Deucravacitinib’s Safety and Efficacy

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This week, 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. These findings further support deucravacitinib as a viable oral treatment option for patients requiring long-term disease control.¹

“Today’s findings demonstrate the continued long-term safety and efficacy profile of [deucravacitinib], with patients maintaining skin clearance over 5 years,” said Mark Lebwohl, MD, Dermatology Times editorial advisory board member, 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, said in a press release. “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.”

While various systemic therapies exist for psoriasis, some patients remain inadequately treated due to efficacy limitations or safety concerns. Deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, has emerged as a novel therapeutic option. The POETYK PSO program, a series of global phase 3 clinical trials, was designed to assess the long-term safety and efficacy of deucravacitinib, providing critical insights into its durability as a treatment option.²

Methods

The 5-year efficacy analysis included 513 patients who received continuous deucravacitinib treatment from the start of the POETYK PSO-1 and POETYK PSO-2 trials through the POETYK PSO-LTE trial. The safety analysis incorporated 1,519 patients with at least 1 dose of deucravacitinib. Efficacy was measured using Psoriasis Area and Severity Index (PASI) scores and static Physician’s Global Assessment (sPGA) ratings, with a modified non-responder imputation (mNRI) method applied for analysis. The LTE trial followed patients for 256 weeks, ensuring robust long-term data collection.

Results

Efficacy outcomes remained stable over f5 years for patients receiving continuous deucravacitinib treatment:

• PASI 75 response rate: 72.1% at year 1, 67.3% at year 5
• PASI 90 response rate: 45.9% at year 1, 46.3% at year 5
• sPGA 0/1 (clear/almost clear): 57.5% at year 1, 52.6% at year 5

Researchers stated these findings indicate that clinical improvements achieved in the first year of treatment are largely maintained over time. Additionally, the long-term safety profile remained consistent, with no new safety signals observed in over 5,000 patient-years of exposure. Reported adverse events were in line with previous findings, with no significant increase in severe reactions, reinforcing deucravacitinib’s favorable risk-benefit profile.

“These positive 5-year results build upon the established profile of [deucravacitnib] , 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, in the release. “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.”

Discussion

These results reinforce deucravacitinib’s role as a first-in-class TYK2 inhibitor for moderate to severe plaque psoriasis. The sustained efficacy and stable safety profile suggests that deucravacitinib could become an oral standard of care for patients requiring durable disease control. The ability to maintain PASI 75 and PASI 90 responses over 5 years underscores its potential to improve long-term patient outcomes. Given the chronic nature of psoriasis, a treatment that offers consistent disease control without additional safety concerns is a crucial advancement.

Future research may explore deucravacitinib’s application in other immune-mediated diseases beyond psoriasis, such as psoriatic arthritis, inflammatory bowel disease, and lupus. Additional studies evaluating real-world efficacy and long-term patient adherence could further solidify its position as a mainstay treatment.

Conclusion

The 5-year POETYK PSO LTE trial results demonstrate that deucravacitinib maintains both efficacy and safety over extended use, offering a durable treatment option for moderate to severe plaque psoriasis. These findings provide strong support for deucravacitinib’s long-term use in clinical practice and highlight its potential as a transformative therapy for immune-mediated diseases.

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. Published February 16, 2025. Accessed February 18, 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. Lebwohl M, Warren RB, Sofen H, et al. Deucravacitinib in plaque psoriasis: 2-year safety and efficacy results from the phase III POETYK trials. Br J Dermatol. 2024;190(5):668-679. doi:10.1093/bjd/ljae014