Key Takeaways
•The POETYK PSO long-term extension trial demonstrated that Sotyktu maintains a consistent safety profile over five years.
•Clinical responses, including PASI 90, were sustained in nearly half of the patients throughout the study period.
•These findings reinforce Sotyktu’s potential as a long-term oral treatment option for moderate-to-severe plaque psoriasis.
Bristol Myers Squibb has released five-year data from the POETYK PSO long-term extension (LTE) trial, evaluating the safety and efficacy of Sotyktu (deucravacitinib) in adults with moderate-to-severe plaque psoriasis. The study encompassed over 5,000 patient-years of exposure, revealing no new safety concerns and confirming a consistent safety profile for Sotyktu.
These results were presented at the Winter Clinical Dermatology Conference in Hawaii. Dr. Mark Lebwohl, dean of Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai, highlighted that patients maintained significant skin clearance over the five-year period, underscoring Sotyktu’s role as a potential oral standard of care in psoriasis treatment.
Sustained Efficacy Over Five Years
The trial’s efficacy analysis included 513 patients who received continuous Sotyktu treatment from the onset of the pivotal POETYK PSO-1 and POETYK PSO-2 trials and transitioned into the LTE phase. Findings demonstrated that clinical responses were durable over the five-year span, with 67.3% of patients achieving Psoriasis Area and Severity Index (PASI) 75 and 46.3% reaching PASI 90 at Year 5. Additionally, 52.6% of participants attained a static Physician’s Global Assessment (sPGA) score of 0 or 1, indicating clear or almost clear skin.
Dr. Edgar Charles, vice president at Bristol Myers Squibb, emphasized that these positive outcomes reinforce Sotyktu’s profile as a transformative oral therapy for psoriasis, reflecting the company’s commitment to advancing TYK2 innovation and setting new standards in patient care.
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