POETYK-PSO LTE: No New Safety Signals for Deucravacitinib at Five Years

Key Takeaways

• Deucravacitinib maintained PASI 75/90 response rates and sPGA 0/1 scores over 5 years in patients with moderate-to-severe plaque psoriasis.
• No new safety signals identified across more than 5,000 patient-years of exposure.
• The manufacturer said the results suggest support deucravacitinib's continued use in long-term plaque psoriasis management.

Sotyktu (deucravacitinib) showed sustained efficacy and an acceptable safety profile over a period of 5 years in adults with moderate-to-severe plaque psoriasis, according to an announcement by Bristol Myers Squibb.

Based on recent updates from the POETYK-PSO long-term extension (LTE) trial, which included over 5,000 patient-years of exposure, the mannufacturer reported no new safety signals emerging during the study period. According to the press release, the safety profile of deucravacitinib observed in year 1 was consistent throughout 5 years of follow-up. Clinical response rates were steady among continuously treated patients.

Primary outcomes of interest included Psoriasis Area and Severity Index (PASI) 75 and 90 response rates and Static Physician Global Assessment (sPGA) 0/1 scores from year one to year five. Sustained efficacy was observed for three outcome measures: PASI 75 (72.1%, year 1; 67.3%, year 5), PASI 90 (45.9%, year 1; 46.3%, year 5) and sPGA 0/1 (57.5%, year 1; 52.6%, year 5).

“Today’s findings demonstrate the continued long-term safety and efficacy profile of deucravacitinib with patients maintaining skin clearance over five years,” said 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 on the study, 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.”

The results of the extension study were recently presented at the Winter Clinical Dermatology Conference in Hawaii. 

Source: Bristol Meyers Squibb press release. February 17, 2025.

Disclosure: Mark Lebwohl, MD, is paid consultant for Bristol Myers Squibb