POETYK PsA-2 Trial Shows Efficacy of Sotyktu as an Oral Therapy for Psoriatic Arthritis

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Findings from the Phase III POETYK PsA-2 trial (NCT04908189) show Sotyktu (deucravacitinib) produced a significant improvement in the symptoms of psoriatic arthritis (PsA) compared to placebo after 16 weeks with a tolerable safety profile.^1,2 These results follow recent data from the long-term extension of the POETYK PSO clinical trial program showing the efficacy of Sotyktu treating moderate-to-severe plaque psoriasis, further reinforcing the drug’s role in the treatment of dermatologic conditions.³

“Given the complex, multifaceted and heterogenous nature of psoriatic arthritis, there continues to be a significant need for safe and effective oral treatments,” Philip Mease, MD, director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and clinical professor at the University of Washington School of Medicine, said in a press release. “These results are particularly encouraging because they support the potential for Sotyktu to impact both joint and skin symptoms, as well as patient-reported quality of life outcomes. Combined with a well-tolerated safety profile, these data show Sotyktu may serve as an important new treatment option for these patients.”¹

Sotyktu is an oral, selective, allosteric tyrosine kinase 2 inhibitor that has been found to limit cytokine signaling in psoriasis pathogenesis. In addition to POETYK PsA-2, the drug is also being evaluated in POETYK PsA-1 (NCT04908202),⁴ both of which are multicenter, randomized, double-blind, placebo-controlled Phase III trials determining the efficacy and safety of Sotyktu in patients aged 18 years and above with active PsA.

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 (bDMARD). In POETYK PsA-2, investigators enrolled approximately 730 patients with active PsA who were not previously treated with a bDMARD or who received prior treatment with a TNFα inhibitor.

Both trials were comprised of a 52-week treatment period that included a placebo-controlled period lasting through week 16, then a reallocation and continued active treatment period running from week 16 to week 52. Investigators included an Otezla (apremilast) safety reference cohort in POETYK PsA-2.

Both trials had a primary endpoint of proportion of patients who achieved an ACR20 response at week 16. Across both trials, participants completing 52 weeks of treatment may be eligible to enroll in the open-label extension study.

POETYK PsA-2 achieved the primary endpoint, as 54.2% of patients in the Sotyktu cohort achieved ACR20 compared to 39.4% in the placebo cohort (p=0.0002). 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. In terms of safety, the overall profile of Sotyktu at 16 weeks was consistent with Phase II PsA trial findings and results from the POETYK PSO clinical trial program in moderate-to-severe plaque psoriasis.

“These promising new data demonstrate the potential of Sotyktu as an oral therapy and the first TYK2 inhibitor that may be able to address significant unmet needs of patients living with psoriatic arthritis,” Edgar Charles, MD, vice president and senior global program lead, Early & Late Development Immunology, Bristol Myers Squibb, said in the release. “Furthermore, these results support our belief in the capability of Sotyktu in rheumatic conditions and reflect our ongoing commitment to developing medicines for people living with immune-mediated diseases.”¹

References

1. 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 March 11, 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

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 or Had Previously Received TNFα Inhibitor Treatment. ClinicalTrials.gov. Updated November 1, 2024. Accessed March 11, 2025. https://www.clinicaltrials.gov/study/NCT04908189

3. New Four-Year Sotyktu (deucravacitinib) Data Demonstrate Durable Response Rates and Consistent Safety in Moderate-to-Severe Plaque Psoriasis. News release. Bristol Myers Squibb. May 17, 2024. Accessed March 11, 2025. https://news.bms.com/news/corporate-financial/2024/New-Four-Year-Sotyktu-deucravacitinib-Data-Demonstrate-Durable-Response-Rates-and-Consistent-Safety-in-Moderate-to-Severe-Plaque-Psoriasis/default.aspx

4. An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis (POETYK-PSO-2). ClinicalTrials.gov. Updated December 20, 2022. Accessed March 11, 2025. https://clinicaltrials.gov/study/NCT03611751