A phase 3 trial evaluating the efficacy and safety of 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 met both co-primary and secondary end points.

The multicenter, randomized, double-blind, placebo- and active-controlled POETYK PSO-1 study included 666 patients aged 18 years and older with moderate to severe plaque psoriasis. Patients were randomized to receive deucravacitinib 6mg orally once daily, Otezla® (apremilast; Amgen) or placebo. 

The co-primary 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 Otezla at week 16.

Results showed that treatment with deucravacitinib demonstrated superiority to placebo and Otezla at week 16 with a higher proportion of patients achieving PASI 75 and sPGA 0/1. The safety profile of deucravacitinib was consistent with that seen in previous phase 2 results.

Detailed study data will be shared at a future medical meeting following a full evaluation by the Company and principal investigators.

“With limited oral therapeutic options available for psoriasis, there remains a significant need for safe and effective oral therapies. This makes the positive topline results for deucravacitinib in the POETYK PSO-1 trial exciting for the psoriasis community,” said April Armstrong, MD, MPH, Associate Dean and Professor of Dermatology at the University of Southern California. “These findings indicate deucravacitinib has the potential to be a new treatment option for people living with psoriasis and may provide clinically meaningful improvements with the convenience of oral administration.”

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Additionally, the Company is evaluating deucravacitinib in a second phase 3 POETYK PSO-2 study for moderate to severe plaque psoriasis with results expected in the first quarter of 2021. Deucravacitinib is also being investigated in a wide spectrum of immune-mediated diseases, including psoriatic arthritis.

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Bristol Myers Squibb announces deucravacitinib (BMS-986165) demonstrated superiority to placebo and Otezla® (apremilast) in pivotal phase 3 psoriasis study. [press release]. Princeton, NJ: Bristol Myers Squibb; November 3, 2020.