Deucravacitinib Improves PsA Symptoms and Quality of Life in POETYK PsA-2

Use of deucravacitinib (Sotkytu) can improve signs and symptoms of psoriatic arthritis (PsA) as well as provide quality of life benefits among patients who had never used biologics or had previously received TNF inhibitors, according to data from the POETYK PSA-2 trial.

Results of the study, which were presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting, confirm the benefit of deucravacitinib from POETYK PSA-1 and add further understanding to its effects across a wide range of patients with PsA.1,2

“Given the complex, multifaceted and heterogenous nature of psoriatic arthritis, there continues to be a significant need for safe and effective oral treatments,” said 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, Seattle.2 “These results are particularly encouraging because they support the potential for [deucravacitinib] 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 [deucravacitinib] may serve as an important new treatment option for these patients.”

Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 inhibitor developed and marketed by Bristol Myers Squibb. The agent received approval from the US Food and Drug Administration in 2022 for moderate to severe plaque psoriasis based on the POETYK PSO-1 and POETYK PSO-2 trials, but has yet to receive an indication for PsA. According to the March 08, 2025 release, Bristol Myers Squibb intends to discuss the data from the POETYK program with regulatory authorities in the future.1,2,3

POETYK PsA-2 is the second phase 3 trial from the POETYK-PsA program. POETYK PsA-1 enrolled approximately 670 patients with active PsA who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD). Unlike POETYK PsA-1, POETYK PsA-2 included both bDMARD naive and patients with a history of treatment with TNF inhibitors.1,2

Per trial protocol, patients were randomized to deucravacitinib, apremilast, or placebo therapy. The trials both used the proportion of participants achieving an ACR20 response at week 16 as the primary outcome of interest. Of note, apremilast was included in POETYK PsA-2 for safety reference.1,2

Primary outcome analysis from the trial revealed a significantly greater proportion of the deucravacitinib group achieved ACR20 response relative to the placebo group at 16 weeks (54.2% vs 39.4%; P = .0002). Further analysis suggested the deucravacitinib group had a significantly greater proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 responses and significantly greater improvements from baseline in the patient-reported Health Assessment Questionnaire-Disability Index compared with placebo (−0.32 vs −0.21, respectively; P = .0013).1,2

Analysis of safety data from the trial suggested adverse events were reported in 62.8%, 73.3%, and 54.7% of patients in the deucravacitinib, apremilast, and placebo arms, respectively. Further reanalysis of safety data demonstrated serious adverse events occurred among 1.9%, 3.8%, and 1.0% in the deucravacitinib, apremilast, and placebo arms, respectively.1,2

“These promising new data demonstrate the potential of [deucravacitinib] as an oral therapy and the first TYK2 inhibitor that may be able to address significant unmet needs of patients living with psoriatic arthritis,” said Edgar Charles, MD, vice president and senior global program lead, Early & Late Development Immunology at Bristol Myers Squibb.2 “Furthermore, these results support our belief in the capability of [deucravacitinib] in rheumatic conditions and reflect our ongoing commitment to developing medicines for people living with immune-mediated diseases.”

References:

1. Thaci D. Efficacy and safety of deucravacitinib in patients with active psoriatic arthritis who are naive to biologic disease-modifying anti-rheumatic drugs or previously received TNF inhibitor treatment.Presented at the 2025 American Academy of Dermatology (ADA) Annual Meeting. Orlando, FL. March 07-11, 2025.

2. Bristol Myers Squibb. 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. Bristol Myers Squibb. March 8, 2025. Accessed March 9, 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.

3. Bristol Myers Squibb. U.S. Food and Drug Administration Approves SotyktuTM (Deucravacitinib), oral treatment for adults with moderate-to-severe plaque psoriasis. Bristol Myers Squibb. September 9, 2022. Accessed March 9, 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.