Positive results were announced from a second phase 3 trial evaluating deucravacitinib (BMS-986165; Bristol Myers Squibb), a novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis.
The double-blind, placebo and active-controlled POETYK PSO-2 trial included 1022 patients 18 years of age and older with moderate to severe plaque psoriasis. Patients were randomly assigned to receive deucravacitinib 6mg orally once daily, apremilast 30mg orally twice daily, or placebo.
The coprimary end points were the percentage of patients who achieved Psoriasis Area and Severity Index (PASI) 75 and the percentage of patients who achieved static Physician’s Global Assessment (sPGA) score of 0 to 1, compared with placebo, at week 16. Key secondary end points included the percentage of patients who achieved PASI 75 and sPGA 0/1 compared with apremilast at week 16.
Results showed that a significantly greater proportion of patients treated with deucravacitinib achieved PASI 75 and sPGA 0/1 at week 16 compared with placebo. Additionally, deucravacitinib was found to be superior to apremilast, with a greater proportion of patients achieving PASI 75 and sPGA 0/1 at week 16.
“Deucravacitinib was designed to be a selective TYK2 inhibitor that inhibits the IL-12, IL-23 and Type 1 IFN pathways, which are implicated in multiple immune-mediated diseases,” said Samit Hirawat, MD, executive vice president, chief medical officer, global drug development, Bristol Myers Squibb. “The superior efficacy we have observed in patients with moderate to severe psoriasis, combined with the well-tolerated safety profile, are consistent with the novel mechanism of action of deucravacitinib, a potential new class of molecule.”
The Company is also investigating deucravacitinib for a wide range of immune-mediated diseases, including psoriatic arthritis, lupus, and inflammatory bowel disease.
Bristol Myers Squibb announces positive topline results from second pivotal phase 3 psoriasis study showing superiority of deucravacitinib compared to placebo and Otezla® (apremilast). [press release]. Princeton, NJ: Bristol Myers Squibb; February 2, 2021.