Bristol-Myers Squibb reported positive results from POETYK PSO-1, the first pivotal Phase 3 trial evaluating deucravacitinib (BMS-986165) versus Otezla (apremilast) and placebo in patients with moderate to severe plaque psoriasis. Patients in the deucravacitinib treatment arm met both co-primary endpoints versus placebo, and met multiple key secondary endpoints, including one endpoint showing deucravacitinib was superior to Otezla (apremilast).
POETYK PSO-1 (PrOgram to Evaluate the efficacy and safety of BMS-986165, a selective TYK2 inhibitor PSO-1) is the first of two global Phase 3 studies. The multi-center, randomized, double-blind, placebo- and active comparator-controlled study enrolled 666 patients diagnosed with moderate to severe plaque psoriasis. The co-primary outcome measures of the trial 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 at Week 16 versus placebo. Key secondary outcome measures of the trial include percentage of patients who achieved PASI 75 and sPGA 0/1 compared to Otezla at Week 16.
Patients treated with 6 mg of deucravacitinib once daily met both co-primary endpoints versus placebo, with more patients achieving PASI 75, defined as at least a 75 percent improvement in PASI, and a static Physician’s Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment with deucravacitinib. The trial also met multiple key secondary endpoints, including showing deucravacitinib was superior to Otezla (apremilast) in the proportion of patients reaching a PASI 75 response and sPGA 0/1 at Week 16. The overall safety profile of deucravacitinib in the POETYK PSO-1 trial was consistent with previously reported results.
Results from the second study, POETYK PSO-2, are expected in the first quarter of 2021.
About Deucravacitinib (BMS-986165)
Deucravacitinib (BMS-986165) is an oral, selective tyrosine kinase 2 (TYK2). Deucravacitinib’s selectivity is driven by a unique mechanism of action that is distinct from other kinase inhibitors. TYK2 is an intracellular signaling kinase that mediates signaling of IL-23, IL-12 and Type I IFN, which are naturally occurring cytokines involved in inflammatory and immune responses.
Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients’ physical health, quality of life and work productivity. Psoriasis is a serious global problem, impacting at least 100 million people worldwide. Up to 90% of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis, which is characterized by distinct, round or oval plaques typically covered by silvery white scales. People with psoriasis can experience social stigma that can lead to significant psychological distress, while accompanying pain can cause functional disability and reduced quality of life. Psoriasis is associated with multiple comorbidities that are known to reduce life expectancy, including cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease, depression and malignancies.