By: IPP Bureau
Last updated : October 30, 2025 10:41 am
Sotyktu continues to demonstrate consistent efficacy and safety across rheumatic conditions
Bristol Myers Squibb (BMS) announced new late-breaking data reinforcing the efficacy and safety of Sotyktu (deucravacitinib) in patients with psoriatic arthritis (PsA) and systemic lupus erythematosus (SLE).
The findings, presented at the American College of Rheumatology (ACR) Convergence 2025 in Chicago, Illinois, highlight results from the pivotal Phase 3 POETYK PsA-1 trial and the Phase 2 PAISLEY-SLE and PAISLEY long-term extension (LTE) studies.
In the POETYK PsA-1 trial, Week 52 data confirmed that Sotyktu delivered meaningful and durable clinical responses, including inhibition of radiographic progression and sustained improvements in patient-reported outcomes among adults with active psoriatic arthritis who were biologic disease-modifying antirheumatic drug (bDMARD)-naïve. The safety profile through Week 52 remained consistent with the established Sotyktu profile, with no new safety signals identified.
“Sotyktu continues to demonstrate consistent efficacy and safety across rheumatic conditions,” said Dennis Grasela, Vice President and Senior Global Program Lead, Immunology and Cardiovascular, Bristol Myers Squibb. “These data strengthen our confidence in Sotyktu’s potential as a treatment for psoriatic arthritis and systemic lupus erythematosus, as we continue to pursue regulatory discussions worldwide and advance our Phase 3 lupus program.”
Dr. Philip Mease, Director of Rheumatology Research at Providence Swedish Medical Center and Clinical Professor at the University of Washington School of Medicine, added: “Psoriatic arthritis remains a complex, heterogeneous disease with ongoing unmet needs. These results highlight the promise of Sotyktu as an effective oral therapy capable of improving both joint and skin manifestations, with a reassuring safety profile.”
No new safety concerns were observed through Week 52, with the most frequent adverse event being upper respiratory infection. Serious adverse events and discontinuations due to adverse events were infrequent, and no new signals related to major adverse cardiovascular events, venous thromboembolism, or opportunistic infections were identified. Regulatory applications for Sotyktu for PsA are currently under review in the U.S., Europe, Japan, and China, with a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.
“New systemic lupus treatments are urgently needed, as many patients fail to achieve treatment goals with existing options,” said Dr. Eric F. Morand, Head of Rheumatology, Monash University, Australia. “These findings represent the longest follow-up of a TYK2 inhibitor in lupus to date, reinforcing Sotyktu’s potential as a novel oral therapy capable of maintaining long-term efficacy and safety.”