BMS announces positive topline results from second pivotal phase III POETYK PSO-2 psoriasis study showing superiority of deucravacitinib over placebo and Otezla .

Bristol Myers Squibb announced positive results from POETYK PSO-2, the second pivotal Phase III trial evaluating deucravacitinib, a novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. POETYK PSO-2 evaluated deucravacitinib 6 mg once daily and met both co-primary endpoints versus placebo , with significantly more patients achieving Psoriasis Area and Severity Index (PASI 75), defined as at least a 75 percent improvement of baseline 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 6 mg once daily was superior to Otezla (apremilast) in the proportion of patients reaching PASI 75 and sPGA 0/1 at Week 16 . The overall safety profile of deucravacitinib in POETYK PSO-2 remains consistent with previously reported results and consistent with the mechanism of action of deucravacitinib. POETYK PSO-2 is the second of two global Phase III studies demonstrating superiority of once daily deucravacitinib compared to placebo and Otezla in patients with moderate to severe plaque psoriasis . Positive topline results from the first Phase III trial, POETYK PSO-1, were announced in November 2020. The company and key investigators will complete a full evaluation of the POETYK PSO-2 data and share the detailed results at a future medical meeting. The trial also met multiple key secondary endpoints, including showing deucravacitinib 6 mg once daily was superior to Otezla (apremilast) in the proportion of patients reaching PASI 75 and sPGA 0/1 at Week 16. The overall safety profile of deucravacitinib in POETYK PSO-2 remains consistent with previously reported results and consistent with the mechanism of action of deucravacitinib.