Bristol Myers Squibb Unveils Compelling Late-Breaking Phase 3 Data Highlighting the Efficacy of Sotyktu (Deucravacitinib) in Treating Psoriatic Arthritis
Bristol Myers Squibb has announced new late-breaking clinical data from the pivotal Phase 3 POETYK PsA-1 trial, reinforcing the potential of its oral, selective TYK2 inhibitor, Sotyktu® (deucravacitinib), as an effective treatment for adults with active psoriatic arthritis (PsA). The findings were presented as part of a late-breaking abstract session (#LB0001) at the European Alliance of Associations for Rheumatology (EULAR) Congress 2025, held June 11–14 in Barcelona, Spain.
Achieving the Primary Endpoint: Sotyktu Demonstrates Superiority Over Placebo
The POETYK PsA-1 trial, officially designated as study IM011-054, enrolled patients with active PsA who had not received prior treatment with biologic disease-modifying antirheumatic drugs (bDMARDs). At the 16-week primary analysis point, Sotyktu met its primary endpoint, demonstrating a statistically significant improvement in ACR20 response rate — defined as at least a 20% improvement in joint tenderness and swelling — compared with placebo. Specifically, 54.2% of patients treated with Sotyktu achieved an ACR20 response, compared to 34.1% in the placebo group (p<0.0001).
These findings underscore the meaningful clinical efficacy of Sotyktu in alleviating the signs and symptoms of psoriatic arthritis, a chronic, inflammatory condition that affects both the skin and joints and significantly impacts patients’ quality of life.
A Robust Safety Profile Consistent with Prior Trials
Importantly, the safety profile of Sotyktu through 16 weeks of treatment in POETYK PsA-1 was consistent with what had been previously reported in earlier studies, including the POETYK PsA-2 trial and the Phase 3 clinical trials evaluating Sotyktu in moderate-to-severe plaque psoriasis (PsO). No new safety signals emerged, and the treatment continued to be well tolerated.
Improvements Across Key Secondary Endpoints
Beyond the primary ACR20 endpoint, Sotyktu also demonstrated efficacy across a range of secondary endpoints in the POETYK PsA-1 trial:
- PASI 75 Response: Indicating a 75% or greater improvement in skin lesions.
- HAQ-DI (Health Assessment Questionnaire-Disability Index): A measure of physical functioning and disability.
- SF-36 PCS (Short Form-36 Physical Component Summary): A validated patient-reported outcome assessing physical health.
- Minimal Disease Activity (MDA): A composite measure reflecting low disease activity across multiple domains.
Furthermore, ACR50 and ACR70 responses — representing 50% and 70% improvement in PsA symptoms — were also observed at nominally significant levels. Improvements were additionally recorded in other parameters such as:
- FACIT-Fatigue: A patient-reported fatigue scale.
- DAS28-CRP (Disease Activity Score in 28 joints – C-reactive protein): A validated inflammatory disease activity metric.
- Dactylitis Resolution: Measured through pooled analysis, capturing resolution of a hallmark PsA symptom characterized by swollen digits.
These comprehensive improvements highlight the multi-dimensional benefits of Sotyktu, not only in musculoskeletal inflammation but also in skin manifestations, patient functionality, and fatigue — all key challenges faced by individuals with psoriatic arthritis.
Insights from POETYK PsA-2: Sustained Efficacy Through One Year
In parallel to POETYK PsA-1, new data from the Phase 3 POETYK PsA-2 trial (abstract #OP0095) were also unveiled at EULAR 2025. This study included a broader patient population, including both bDMARD-naïve patients and those previously treated with TNFα inhibitors.
At Week 16, Sotyktu again demonstrated superior efficacy compared with placebo, with 54.2% of patients achieving an ACR20 response versus 39.4% in the placebo group (p=0.0002).
Notably, patients continuing on Sotyktu through Week 52 exhibited sustained and even enhanced therapeutic response:
- 62.2% of patients receiving continuous Sotyktu achieved ACR20 response at Week 52.
- 67.3% of patients who switched from placebo to Sotyktu after Week 16 also achieved ACR20.
These trends held true for higher ACR thresholds (ACR50 and ACR70) as well as key secondary endpoints:
- PASI 75
- MDA
- HAQ-DI
- SF-36 PCS
As with the earlier data, Sotyktu’s safety profile through 52 weeks remained favorable and consistent, with no unexpected adverse events reported.
A New Era in Oral Treatment Options for Psoriatic Arthritis
Commenting on the findings, Dr. Philip Mease, Director of Rheumatology Research at Providence Swedish Medical Center and Clinical Professor at the University of Washington School of Medicine, noted:
“Psoriatic arthritis can be a complex, multifaceted and heterogeneous disease, underscoring the significant need to equip healthcare providers with new safe and effective oral treatment options. 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.”
Dr. Mease’s remarks emphasize the unmet need in PsA and the potential role of Sotyktu in bridging gaps in care, particularly for patients who prefer oral medications over injectable biologics.
Regulatory Landscape and Future Outlook
Sotyktu is already approved in multiple countries for the treatment of adults with moderate-to-severe plaque psoriasis. These new findings from POETYK PsA-1 and PsA-2 support the potential expansion of its therapeutic label to include psoriatic arthritis, pending regulatory review and approval.
Bristol Myers Squibb has indicated that it will collaborate with leading clinical investigators to present additional data from the POETYK PsA program at upcoming medical congresses and to engage with regulatory authorities worldwide to pursue further approvals.
In Summary, the data presented at EULAR 2025 reinforces the promise of Sotyktu (deucravacitinib) as a novel oral therapeutic for psoriatic arthritis. With robust efficacy in both joint and skin domains, favorable patient-reported outcomes, a consistent safety profile, and sustained long-term benefits, Sotyktu is poised to become a valuable treatment option for PsA patients globally.
