Deucravacitinib Shows Superiority in Psoriatic Arthritis Phase 3 Trial

Today, positive late-breaking results from the pivotal phase 3 POETYK PsA-1 (NCT04908202) and POETYK PsA-2 (NCT04908189) trials were released, showing that deucravacitinib (Sotyktu; Bristol Myers Squibb), an oral tyrosine kinase 2 (TYK2) inhibitor, significantly outperformed placebo in improving joint and skin symptoms, disease activity, and quality of life in adults with active psoriatic arthritis.¹ These findings, presented at the EULAR 2025 Congress, highlight the drug’s potential as a new treatment option for patients who are biologic-naïve or have had prior therapy, with clinical responses maintained through 52 weeks.

Late-breaking data reveal durable improvements in joint, skin, and quality-of-life outcomes with deucravacitinib. | Image credit: Oporty786 - stock.adobe.com

“Psoriatic arthritis can be a complex, multifaceted and heterogeneous disease, underscoring the significant need to equip health care providers with new safe and effective oral treatment options,” 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, in a statement.¹ “Improvements in joint and skin symptoms, as well as quality of life, are important treatment goals, and the results demonstrated in this phase 3 study across these parameters highlight the potential of Sotyktu as a new way of treating this debilitating disease.”

In 2022, the FDA approved deucravacitinib as a first-in-class, oral, selective TYK2 inhibitor for adults with moderate to severe plaque psoriasis.² Based on results from the phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials, deucravacitinib demonstrated superior skin clearance compared with both placebo and apremilast (Otezla), with a favorable safety and tolerability profile.

In the 3 POETYK PsA-1 trial, patients treated with deucravacitinib experienced statistically significant improvements in American College of Rheumatology 20 (ACR20), ACR50, and ACR70 responses compared with placebo, along with substantial skin clearance as shown by Psoriasis Area and Severity Index (PASI) 75 responses (51.9% vs. 7.1%) by week 16.¹ Key secondary patient-reported end points, including reductions in Health Assessment Questionnaire - Disability Index (HAQ-DI) and improvements in Physical Component Summary (SF-36 PCS) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scores, were also achieved.

Additionally, improvements were observed in composite measures such as Minimal Disease Activity (MDA), and nominally significant benefits were seen in Disease Activity Score 28 for Rheumatoid Arthritis (DAS28-CRP) scores and pooled analyses of dactylitis and Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC) enthesitis resolution. While the prespecified analysis of radiographic progression did not reach statistical significance, post hoc analysis showed a greater proportion of patients on deucravacitinib had no progression at week 16. The safety profile was favorable, with no new signals identified and comparable rates of adverse events between treatment arms.

In the POETYK PsA-2 trial, deucravacitinib demonstrated sustained and continued improvement in clinical responses through week 52 in patients with active psoriatic arthritis, including those who were biologic disease modifying antirheumatic drug–naïve or previously treated with TNFα inhibitors. At week 16, significantly more patients receiving deucravacitinib achieved an ACR20 response compared with placebo (54.2% vs. 39.4%; P = .0002), with ACR20 rates increasing to 62.2% for patients on continuous deucravacitinib and 67.3% for those who switched from placebo by week 52. Improvements in ACR50, ACR70, PASI 75, MDA response, HAQ-DI, and SF-36 PCS were also maintained or enhanced through week 52.

“These positive phase 3 data build on the strong results from our POETYK Phase 3 PsA-2 trial and underscore the potential of Sotyktu as an oral, first-in-class TYK2 inhibitor for people living with psoriatic arthritis,” said Dennis Grasela, PharmD, PhD, vice president and senior global program lead, Immunology and Cardiovascular, Bristol Myers Squibb, in a statement. “The potential of Sotyktu for this chronic, progressive disease exemplifies our commitment to the pursuit of transformative medicines for rheumatic conditions. We look forward to discussing the POETYK PsA-1 and PsA-2 results with global regulatory authorities.”

References

1. Bristol Myers Squibb presents late-breaking data from pivotal phase 3 POETYK PsA-1 trial demonstrating superiority of Sotyktu (deucravacitinib) compared with placebo in adults with psoriatic arthritis. Bristol Myers Squibb. News release. June 11, 2025. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-Late-Breaking-Data-from-Pivotal-Phase-3-POETYK-PsA-1-Trial-Demonstrating-Superiority-of-Sotyktu-deucravacitinib-Compared-with-Placebo-in-Adults-with-Psoriatic-Arthritis/default.aspx

2. US Food and Drug Administration approves Sotyktu (deucravacitinib), oral treatment for adults with moderate to severe plaque psoriasis. Bristol Myers Squibb. News release. September 9, 2022. Accessed June 11, 2025. https://news.bms.com/news/details/2022/U.S.-Food-and-Drug-Administration-Approves-Sotyktu-deucravacitinib-Oral-Treatment-for-Adults-with-Moderate-to-Severe-Plaque-Psoriasis/default.aspx