Key Takeaways
- Sotyktu Meets Primary Endpoint in POETYK PsA-1 Trial. In the Phase III POETYK PsA-1 trial, 54.2% of patients receiving Sotyktu achieved an ACR20 response at week 16 compared to 34.1% on placebo (p<0.0001), demonstrating significant efficacy in reducing PsA symptoms.
- Broad Improvements Across Key Secondary Endpoints. Sotyktu-treated patients showed clinically meaningful improvements in PASI 75 response, HAQ-DI score, SF-36 PCS score, and Minimal Disease Activity, underscoring its potential as a comprehensive treatment for PsA.
- Consistent Safety Profile With No New Signals. The safety findings in POETYK PsA-1 were consistent with previous Sotyktu studies, with no new safety signals reported.
Data from the Phase III POETYK PsA-1 trial (NCT04908202) show Sotyktu (deucravacitinib; Bristol Myers Squibb) produced statistically significant efficacy in improving joint and skin symptoms in adults with active psoriatic arthritis (PsA).1,2
Sotyktu Demonstrates Significant Efficacy in Phase III POETYK PsA-1 Trial for Psoriatic Arthritis
These data, presented at the 2025 European Alliance of Associations for Rheumatology Congress, bolster the potential of Sotyktu as a first-in-class oral treatment option for PsA and follow similarly positive outcomes from the POETYK PsA-2 trial (NCT04908189), with efficacy maintained through one year of treatment.3,4
“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,” Philip Mease, MD, director of rheumatology research at Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, Seattle, said in a press release. “Improvements in joint and skin symptoms, as well as quality of life, are important treatment goals, and the results demonstrated in this Phase III study across these parameters highlight the potential of Sotyktu as a new way of treating this debilitating disease.”1
Clinical Profile of Sotyktu Across PsA and Plaque Psoriasis
Sotyktu is an oral, selective, allosteric tyrosine kinase 2 inhibitor that has been found to limit cytokine signaling in psoriasis pathogenesis. In addition to the POETYK PsA trials, data from the POETYK PSO long-term extension trial show sustained efficacy and safety with Sotyktu (in the treatment of moderate-to-severe plaque psoriasis. Seven in 10 adults with moderate-to-severe plaque psoriasis administered Sotyktu were able to maintain a clinical response in the Psoriasis Area and Severity Index (PASI) 75 score, indicating the drug could fill a significant unmet need for this patient population.5
About the POETYK PsA Clinical Trial Program
- Both the POETYK PsA-1 and POETYK PsA-2 trials are multicenter, randomized, double-blind, placebo-controlled studies determining the efficacy and safety of Sotyktu in patients aged 18 years and above with active PsA.
- Both trials included a 52-week treatment regimen with a placebo-controlled treatment period for the first 16 weeks followed by a reallocation and continued active treatment period from week 16 to 52.
- The primary endpoint of POETYK PsA-1 and POETYK PsA-2 was proportion of patients achieving ACR20 response at week 16, which translates to at least a 20% improvement in the signs and symptoms of PsA.
- Key secondary endpoints were assessed at week 16 for various PsA disease activity evaluations. POETYK PsA-1 also has a key secondary endpoint for inhibition of progression of structural joint damage at week 16.
- For POETYK PsA-1, investigators enrolled approximately 670 patients with active PsA who did not receive prior treatment with a biologic disease-modifying antirheumatic drug.
Sotyktu Shows Improvement Across Skin, Joint, and Quality-of-Life Measures
- Sotyktu achieved the primary endpoint of POETYK PsA-1 as 54.2% of patients administered the drug achieved an ACR20 response at week 16 compared to 34.1% in the placebo cohort (p<0.0001).
- Patients in the Sotyktu cohort also achieved several key secondary endpoints, including PASI 75 response, Health Assessment Questionnaire-Disability Index score, 36-Item Short Form Survey Physical Component Summary score, and Minimal Disease Activity response.
- Differences in Functional Assessment of Chronic Illness Therapy-Fatigue Scale score, 28-Joint Disease Activity Score-C-Reactive Protein score, and dactylitis resolution pooled analysis were not deemed significant.
- In terms of safety, the profile of Sotyktu was consistent with prior clinical trial results and no new safety signals were reported.
Long-Term Potential of Sotyktu Treating Immune-Mediated Disease
Data from POETYK PsA-1 were similar to findings from POETYK PsA-2, which also achieved the primary endpoint with 54.2% of patients in the Sotyktu cohort achieving ACR20 compared to 39.4% in the placebo cohort (p=0.0002). In that trial, Sotyktu also achieved key secondary endpoints for PsA disease activity at 16 weeks, with improvement across clinical signs and symptoms, extra-articular manifestations, and patient-reported outcomes.3
“These positive Phase III data build on the strong results from our POETYK Phase III PsA-2 trial and underscore the potential of Sotyktu as an oral, first-in-class TYK2 inhibitor for people living with psoriatic arthritis,” Dennis Grasela, PharmD, PhD, vice president and senior global program lead, Immunology and Cardiovascular, Bristol Myers Squibb, said in the release. “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.”1
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. News release. Bristol Myers Squibb. June 11, 2025. Accessed June 12, 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. A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs. ClinicalTrials.gov. Updated September 27, 2024. Accessed June 12, 2025. https://clinicaltrials.gov/study/NCT04908202
3. Bristol Myers Squibb Presents Late-Breaking Data from Phase 3 POETYK PsA-2 Trial Demonstrating Superiority of Sotyktu (deucravacitinib) Compared with Placebo in Adults with Psoriatic Arthritis. News release. Bristol Myers Squibb. March 8, 2025. Accessed June 12, 2025. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-Late-Breaking-Data-from-Phase-3-POETYK-PsA-2-Trial-Demonstrating-Superiority-of-Sotyktu-deucravacitinib-Compared-with-Placebo-in-Adults-with-Psoriatic-Arthritis/default.aspx
4. A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment. ClinicalTrials.gov. Updated June 11, 2025. Accessed June 12, 2025. https://www.clinicaltrials.gov/study/NCT04908189
5. New Five-Year Sotyktu (deucravacitinib) Data Show Consistent Safety and Durable Response Rates in Moderate-to-Severe Plaque Psoriasis. News release. Bristol Myers Squibb. February 16, 2025. Accessed June 12, 2025. https://news.bms.com/news/corporate-financial/2025/New-Five-Year-Sotyktu-deucravacitinib-Data-Show-Consistent-Safety-and-Durable-Response-Rates-in-Moderate-to-Severe-Plaque-Psoriasis/default.aspx
