Bristol Myers Squibb Announces Phase 3 POETYK PsA-1 Trial Met Primary Endpoint For Sotyktu In Psoriatic Arthritis

Significantly more patients treated with Sotyktu achieved improvements in joint and skin symptoms, measures of disease activity and quality of life at Week 16 in POETYK PsA-1

New data from POETYK PsA-2 trial demonstrated that meaningful clinical responses continued to improve and outcomes were maintained through Week 52

Sotyktu demonstrated safety consistent with the established clinical profile and was well tolerated in both studies, with no new safety signals

Bristol Myers Squibb (NYSE:BMY) today announced positive data from the pivotal Phase 3 POETYK PsA-1 trial (IM011-054) evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA) who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD). The trial met its primary endpoint, with a significantly greater proportion of patients treated with Sotyktu achievingACR20 response (at least a 20 percent improvement in signs and symptoms of disease) compared with placebo at Week 16 (54.2% versus 34.1%, respectively; p<0.0001). The safety profile of Sotyktu through 16 weeks of treatment was consistent with what has been reported throughout the clinical trial programs for Sotyktu, including the Phase 3 POETYK PsA-2 trial and the Phase 3 moderate-to-severe plaque psoriasis (PsO) clinical trials.

The data for POETYK PsA-1 are being presented as a late-breaking abstract (#LB0001) at the European Alliance of Associations for Rheumatology (EULAR) Congress in Barcelona, Spain, taking place June 11-14, 2025.