The FDA initially approved deucravacitinib (Sotyktu) in September 2022 to treat moderate-to-severe plaque psoriasis.
The safety profile of deucravacitinib (Sotyktu) remains consistent through 5 years, with no new safety signals identified for patients with moderate-to-severe psoriasis, according to new data from the POETYK PSO long-term extension study (NCT04036435). Clinical response rates were also maintained, including scores for Psoriasis Area and Severity Index (PASI) 75, PASI 90, and static Physician’s Global Assessment (sPGA) 0/1.1
Deucravacitinib is a selective tyrosine kinase 2 protein inhibitor that has shown efficacy and safety compared to other biologic agents, including apremilast (Otezla). | Image Credit: SNAB | stock.adobe.com
“Today’s findings demonstrate the continued long-term safety and efficacy profile of Sotyktu, with patients maintaining skin clearance over 5 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, said in a release.1 “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.”
Deucravacitinib is a selective tyrosine kinase 2 protein inhibitor that has shown efficacy and safety compared to other biologic agents, including apremilast (Otezla). It is designed to be administered orally once per day. It was approved by the FDA in September 2022 as a treatment for moderate-to-severe plaque psoriasis for patients who are candidates for systemic therapy or phototherapy and has many off-label uses that involve the overexpression of type I interferons, including systemic sclerosis and systemic lupus erythematosus.2
Trial Name: Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis (POETYK PSO-LTE
ClinicalTrials.gov ID: NCT04036435
Sponsor: Bristol-Myers Squibb
Completion Date (Estimated): July 2026
In a previous analysis, 3-year data supported the long-term safety and efficacy of the drug. Patients from the POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) studies could be enrolled in the open-label extension, with the first patient visit for the extension occurring in August 2019. Safety and efficacy data were assessed during the extension study.3
For 3 years, the investigators found long-term treatment maintained clinical responses until 3 years. As for safety, exposure-adjusted incidence rates of adverse events (AEs) were 144.8 per 100 person-years, serious AEs were 5.5 per 100 person-years, and discontinuations due to AEs were 2.4 per 100 person-years. Investigators noted that these rates decreased or were similar compared with those from the first year. The incidence rates for the most common AEs included nasopharyngitis (11.4 per 100 person-years) and upper respiratory tract infection (6.2 per 100 person-years).3
As for the 5-year data, investigators reported that the clinical outcomes were 72.1% for PASI 75, 45.9% for PASI 90, and 57.5% for sPGA 0/1. The 1-year rates were 67.3%, 46.3%, and 52.6%, respectively. There were 513 patients included in the efficacy analysis and 1519 in the safety analysis.1
“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,” Edgar Charles, MD, vice president and senior global program lead of early and late development immunology at Bristol Myers Squibb, said in the release.1
The data were presented at the Winter Clinical Dermatology Conference — Hawaii in Big Island, Waikoloa Village, Hawaii, from February 14 to February 19, 2025.1
