Bristol Myers' deucravacitinib maintains efficacy at 2 years against plaque psoriasis in study
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Bristol Myers Squibb (NYSE:BMY) said efficacy was maintained through up to two years of treatment with deucravacitinib for plaque psoriasis.
The New York-based pharma giant on May 12 reported two-year data from the POETYK PSO long-term extension (LTE) trial.
Following 52-week phase 3 studies, POETYK PSO-1 and POETYK PSO-2 which compared deucravacitinib to placebo and Amgen's Otezla, patients could enroll in the ongoing POETYK PSO-LTE trial and receive deucravacitinib 6 mg once daily.; 1,221 patients enrolled in the LTE trial and received at least 1 dose of the drug.
Bristol Myers (BMY) said clinical efficacy was maintained through up to two years of treatment with deucravacitinib, with response rates at week 60 in the LTE of 77.7% and 58.7% for Psoriasis Area and Severity Index (PASI) 75 and static Physicians Global Assessment (sPGA) 0/1 (clear/almost clear skin), respectively.
Adverse events (AEs) continued to be predominantly of mild or moderate severity, with the most common AEs continuing to be nasopharyngitis (swelling of nasal passage), upper respiratory tract infection and headache, according to the company.
Bristol Myers (BMY) noted that serious AEs and AEs that lead to discontinuation remained low for up to two years, and no emerging safety signals were seen.
Deucravacitinib is currently under review in the U.S. and EU. The FDA is expected to make a decision by September 10.