New 52-Week Data Reinforce Deucravacitinib’s Benefits for Psoriatic Arthritis and SLE

Today, Bristol Myers Squibb announced new late-breaking data reinforcing the efficacy and safety of deucravacitinib (Sotyktu), a first-in-class, oral, selective TYK2 inhibitor, in 2 rheumatologic diseases: psoriatic arthritis (PsA) and systemic lupus erythematosus (SLE).¹ The findings, presented at the American College of Rheumatology Convergence 2025 in Chicago, Illinois, include 52-week results from the pivotal phase 3 POETYK PsA-1 trial and long-term follow-up from the phase 2 PAISLEY-SLE and PAISLEY long-term extension (LTE) studies.

Psoriatic Arthritis: POETYK PsA-1 Phase 3 Results

The POETYK PsA-1 trial evaluated deucravacitinib in adults with active PsA who were biologic disease-modifying antirheumatic drug (bDMARD)-naïve. Results through Week 52demonstrated sustained and clinically meaningful improvements across multiple PsA domains, with efficacy maintained over time and a consistent safety profile.

At Week 16, ACR20 responses were achieved by 54.2% of patients receiving deucravacitinib compared with 34.1% on placebo (p < 0.0001). By Week 52, ACR20 responses improved further to 63.1% among those who continued deucravacitinib and 60.8% among patients switched from placebo to deucravacitinib at Week 16, aligning with results from the companion POETYK PsA-2 trial.

Radiographic analyses confirmed inhibition of joint damage progression, as measured by the modified Sharp–van der Heijde score. A higher proportion of patients receiving deucravacitinib demonstrated no radiographic progression at Week 16 (82.0% vs. 71.5% with placebo) and Week 52 (73.3% for continuous treatment vs. 66.5% for those switched from placebo). Deucravacitinib also improved patient-reported outcomes and extra-articular manifestations of PsA, with consistent trends for higher-order endpoints (ACR50 and ACR70).

The safety profile through Week 52 remained consistent with previous data from the deucravacitinib development program. The most common adverse effect was upper respiratory infection, and serious events or treatment discontinuations were infrequent. Importantly, no new safety signals—including cardiovascular events, venous thromboembolism, or opportunistic infections—were detected.

“Psoriatic arthritis is a heterogeneous disease that affects patients in diverse and often debilitating ways, and there remains a clear need for oral therapies that can address both joint and skin symptoms,” said Philip Mease, MD, director of rheumatology research at Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, Seattle. “These compelling results build on the previously disclosed data, showing that Sotyktu delivered meaningful improvements across key domains of psoriatic arthritis disease activity with a consistent safety profile, supporting the potential for Sotyktu as a new, first-line, advanced, oral option for patients living with psoriatic arthritis.”¹

Systemic Lupus Erythematosus: PAISLEY-SLE and LTE Findings

An integrated analysis from the phase 2 PAISLEY-SLE and PAISLEY LTE studies showed durable efficacy and consistent safety of deucravacitinib for up to 4 years in patients with moderate-to-severe SLE, marking the longest follow-up to date for a TYK2 inhibitor in lupus. Across up to 222 weeks of treatment, improvements were maintained in key efficacy endpoints, including SLE Responder Index-4 (SRI-4), BICLA, Lupus Low Disease Activity State (LLDAS), and CLASI-50 for cutaneous disease activity.

Patients who transitioned from placebo to deucravacitinib during the LTE achieved comparable responses to those on continuous treatment. Safety findings were favorable across all dosing arms (3 mg BID, 6 mg BID, and 12 mg QD). Serious adverse events occurred in 14.9–21.8% of participants, while discontinuations due to AEs ranged from 11.4–17.3%, with no new safety concerns identified despite concomitant background therapies.

Clinical and Regulatory Outlook

Bristol Myers Squibb plans to pursue regulatory approval for PsA, with applications under review in the US, Europe, Japan, and China, and a PDUFA decision expected March 6, 2026.² Meanwhile, phase 3 trials in SLE are ongoing. The company also continues to expand its immunology pipeline, including early-phase studies of a CD19-directed CAR T-cell therapy (BMS-986353) for refractory SLE, systemic sclerosis, and idiopathic inflammatory myopathies.

“The POETYK PsA-1 Week 52 data and PAISLEY LTE findings reinforce our confidence in Sotyktu for rheumatic conditions and underscore our commitment to addressing unmet needs and the pursuit of bold science that may elevate new standards of care in Immunology,” said Dennis Grasela, vice president and senior global program lead, Immunology and Cardiovascular. “We are eager to continue our discussions on psoriatic arthritis with global health authorities as we seek to add this indication to the approved label around the world. Meanwhile, we are excited about progressing our phase 3 trials in systemic lupus erythematosus, which represent an important part of our robust portfolio in lupus investigating multiple disease pathways.”¹

References

1. Bristol Myers Squibb Presents Two Late-Breaking Presentations Demonstrating Sotyktu (deucravacitinib) Efficacy in Psoriatic Arthritis and Systemic Lupus Erythematosus. News release. Bristol Myers Squib. Published October 27, 2025. Accessed October 27, 2025. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-Two-Late-Breaking-Presentations-Demonstrating-Sotyktu-deucravacitinib-Efficacy-in-Psoriatic-Arthritis-and-Systemic-Lupus-Erythematosus/default.aspx

2. Bristol Myers Squibb’s supplemental new drug application (sNDA) for sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis accepted for review across four regions globally. News release. BioSpace. Published July 21, 2025. Accessed October 27, 2025. https://www.biospace.com/press-releases/bristol-myers-squibbs-supplemental-new-drug-application-snda-for-sotyktu-deucravacitinib-for-the-treatment-of-adults-with-active-psoriatic-arthritis-accepted-for-review-across-four-regions-globally