Bristol Myers’ Sotyktu shows efficacy in arthritis and SLE

Bristol Myers (BMY) announced Week 52 data from the pivotal Phase 3 POETYK PsA-1 trial further confirming the efficacy and safety of Sotyktu – deucravacitinib – in adults with active psoriatic arthritis, or PsA, who were not previously treated with a biologic disease-modifying antirheumatic drug. The company also announced new findings from an integrated analysis of the Phase 2 PAISLEY-SLE and PAISLEY studies supporting the safety and efficacy with up to four years of Sotyktu treatment for moderate-to-severe systemic lupus erythematosus, or SLE. New data showed ACR20 responses – at least a 20% improvement in signs and symptoms of disease – achieved at Week 16 – , Sotyktu 54.2%; placebo, 34.1% – continued to improve and were maintained for patients receiving continuous Sotyktu treatment through Week 52. Patients who switched from placebo to Sotyktu at Week 16 also had a similar ACR20 response at Week 52 – 60.8% -. The overall safety profile of Sotyktu through Week 52 was consistent with that established across the Sotyktu development program. Inhibition of progression of structural joint damage was observed at Week 16 and sustained through Week 52. Additionally, 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, which continued to improve after Week 16 and were maintained through Week 52. No new safety signals were identified through Week 52 in the POETYK PsA-1 trial. Regulatory applications for Sotyktu for the treatment of adults with active PsA are currently under review in the U.S., Europe, Japan and China. The FDA has assigned a Prescription Drug User Fee Act goal date of March 6, 2026. Sotyktu maintained a consistent safety profile and durable efficacy in patients with moderate-to-severe SLE with up to four years of drug exposure, with no new safety signals, despite complex background therapies.