Results from a long-term extension (LTE) study evaluating deucravacitinib in patients with moderate to severe plaque psoriasis showed durable efficacy and a consistent safety profile.
The open-label, multicenter POETYK PSO-LTE trial (ClinicalTrials.gov Identifier: NCT04036435) evaluated the long-term efficacy and safety of deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, in 1221 adults with moderate to severe plaque psoriasis. The trial included patients who were previously enrolled in the 52-week phase 3 POETYK PSO-1 (ClinicalTrials.gov Identifier: NCT03624127) and POETYK PSO-2 (ClinicalTrials.gov Identifier: NCT03611751) trials.
Findings showed that clinical efficacy was maintained through up to 2 years of treatment, with 77.7% and 58.7% of deucravacitinib-treated patients achieving Psoriasis Area and Severity Index (PASI) 75 and static Physician’s Global Assessment (sPGA) of 0 or 1, respectively, at week 60.
“These long-term follow up results add to the growing body of evidence for deucravacitinib, a first-in-class, oral, selective allosteric TYK2 inhibitor with a unique mechanism of action, reinforcing its potential to offer patients with moderate to severe plaque psoriasis an oral treatment option that addresses current gaps in care,” said Jonathan Sadeh, MD, MSc, senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb.
The safety profile of deucravacitinib was consistent with that observed in the previous phase 3 trials. The most common adverse events reported were nasopharyngitis, upper respiratory tract infection, and headache.
In November 2021, the Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis. A Prescription Drug User Fee Act (PDUFA) target date of September 10, 2022 has been set for the application.
The Company is also investigating deucravacitinib for a wide range of immune-mediated diseases, including psoriatic arthritis, lupus, and inflammatory bowel disease.
New two-year deucravacitinib data reinforce durable efficacy and consistent safety profile in treatment of moderate to severe plaque psoriasis. News release. Bristol Myers Squibb. Accessed May 12, 2022. https://www.businesswire.com/news/home/20220511005587/en/New-Two-Year-Deucravacitinib-Data-Reinforce-Durable-Efficacy-and-Consistent-Safety-Profile-in-Treatment-of-Moderate-to-Severe-Plaque-Psoriasis