Bristol Myers Squibb announced Tuesday that the experimental drug deucravacitinib demonstrated superiority over Amgen's Otezla (apremilast) in a Phase III trial of patients with moderate-to-severe plaque psoriasis. Samit Hirawat, chief medical officer at Bristol Myers Squibb, said the data "[support] the strong potential we see for…our novel, oral, selective TYK2 inhibitor, to be an important new therapy in psoriasis."
The POETYK PSO-1 study randomised 666 patients with moderate-to-severe plaque psoriasis to receive deucravacitinib once daily, Otezla or placebo. The trial's co-primary outcome measures are the percentage of participants who achieved at least a 75% reduction in their Psoriasis Area and Severity Index (PASI 75) score from baseline to week 16, as well as the percentage of subjects attaining a static Physician's Global Assessment (sPGA) score of 0 to 1, denoting clear or almost clear, respectively, at week 16 versus placebo.
Top-line results showed that the study met both co-primary endpoints, with more patients in the deucravacitinib arm achieving PASI 75 and treatment success based on their sPGA scores than placebo. POETYK PSO-1 also met multiple key secondary goals, including demonstrating that deucravacitinib was superior to Otezla in the proportion of patients reaching a PASI 75 response and sPGA 0/1 at week 16.
Bristol Myers Squibb said that the overall safety profile of deucravacitinib in the POETYK PSO-1 trial was consistent with previously reported Phase II results. The company plans to share detailed findings from the trial at a future medical meeting. Meanwhile, results from POETYK PSO-2, a second Phase III study of deucravacitinib in patients with moderate-to-severe plaque psoriasis, are expected in the first quarter of 2021.
Deucravacitinib, also known as BMS-986165, is being studied in multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. Bristol Myers Squibb noted that results from a Phase II trial of the drug in psoriatic arthritis will be presented at the American College of Rheumatology (ACR) later this week. For related analysis, read ViewPoints: BMS secures easy psoriasis win over Otezla for oral agent – how safe is it?
Amgen acquired Otezla from Celgene for $13.4 billion in November last year, in connection with the latter's takeover by Bristol Myers Squibb. Otezla generated sales of $538 million in the third quarter, but fell short of analyst expectations of $587 million.
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