New five-year Sotyktu (deucravacitinib) data show consistent safety and durable response rates in moderate-to-severe plaque psoriasis – BMS

Bristol Myers Squibb announced new five-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. The safety profile of Sotyktu remained consistent through five years with more than 5,000 patient-years of exposure in the trial, with no new safety signals identified. In patients who were treated continuously with Sotyktu , clinical response rates were maintained from Year 1 to Year 5, including Psoriasis Area and Severity Index (PASI) 75, PASI 90 and static Physician’s Global Assessment (sPGA) 0/1 (clear/almost clear).

These data were presented at the Winter Clinical Dermatology Conference – Hawaii (WCH) in Big Island, Waikoloa Village 2025.

“Today’s findings demonstrate the continued long-term safety and efficacy profile of Sotyktu, 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 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.”

Clinical efficacy outcomes were sustained in patients who were continuously treated with Sotyktu for 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). The efficacy analysis included 513 patients who received continuous Sotyktu treatment from Day 1 in the pivotal POETYK PSO-1 and POETYK PSO-2 trials and transitioned to the POETYK PSO-LTE trial, while the safety analysis included 1,519 patients who received at least one dose of Sotyktu during the trials. The patients in this five-year analysis completed 256 weeks of treatment. Efficacy was analyzed using the modified nonresponder imputation (mNRI) 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.”

Sotyktu is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis.