Bristol Myers reports data from Phase 3 POETYK PsA-1 trial of Sotyktu

Bristol Myers (BMY) Squibb announced positive data from the pivotal Phase 3 POETYK PsA-1 trial evaluating the efficacy and safety of Sotyktu, or deucravacitinib, in adults with active psoriatic arthritis, or PsA, who were not previously treated with a biologic disease-modifying antirheumatic drug, or bDMARD. The trial met its primary endpoint, with a significantly greater proportion of patients treated with Sotyktu achieving ACR20 response, at least a 20 percent improvement in signs and symptoms of disease, compared with placebo at Week 16. 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 clinical trials. The data for POETYK PsA-1 are being presented as a late-breaking abstract at the European Alliance of Associations for Rheumatology Congress in Barcelona, Spain, taking place June 11-14. Patients treated with Sotyktu saw improvements across a wide range of clinical measures of disease activity, patient-reported outcomes and extra-articular manifestations of PsA at Week 16. Importantly, several key secondary endpoints were met, including Psoriasis Area and Severity Index, or PASI, 75 response, Health Assessment Questionnaire-Disability Index, or HAQ-DI, score, 36-Item Short Form Survey Physical Component Summary, or PCS, score and Minimal Disease Activity, or MDA, response. Additionally, improvements were observed for ACR50 and ACR70 responses. Nominally significant differences were observed in Functional Assessment of Chronic Illness Therapy-Fatigue Scale score, 28-Joint Disease Activity Score-C-Reactive Protein score and dactylitis resolution pooled analysis. In addition, inhibition of radiographic progression was observed with Sotyktu at Week 16 in post hoc analyses. While the prespecified analysis did not show a statistically significant difference between Sotyktu and placebo in mean change from baseline (CfB) in the modified Sharp-van der Heijde (mSvdH) score, results from a post hoc analysis demonstrated a statistically significant difference between the treatment groups. Further, a significantly greater proportion of patients treated with Sotyktu did not have radiographic progression versus placebo. No new safety signals were identified in the POETYK PsA-1 trial. Additionally, new data from the pivotal Phase 3 POETYK PsA-2 trial, which evaluated patients with active PsA who were bDMARD naive or had previously received TNFalpha inhibitor treatment, is also being presented at the meeting. Results showed superior efficacy of Sotyktu compared with placebo at Week 16. Additionally, through Week 52, clinical responses continued to improve for those who remained on or switched to Sotyktu treatment, and outcomes were maintained for those receiving continuous Sotyktu treatment.