Validating Deucravacitinib’s Anticipated Expansion to Psoriatic Arthritis, with Philip Mease, MD

The psoriatic arthritis (PsA) field is looking forward to the potential addition of a new mechanism of action to the treatment landscape – deucravacitinib, an oral, selective TYK2 inhibitor already approved for people with psoriasis.1 Based off of positive data from the phase 3 POETYK PsA-1 trial, the latest findings from which were presented at the European Alliance of Associations for Rheumatology (EULAR) Congress in June in Barcelona, Spain, Bristol Myers Squibb submitted and the FDA accepted the supplemental New Drug Application (sNDA) for the PsA indication with a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.2,3

As presented at EULAR, POETYK PsA-1 met its primary endpoint of achieving ACR20 response at week 16 compared to placebo (54.2% vs 34.1%; P <.0001) in adults with active PsA who were not previously treated with a biologic disease-modifying anti-rheumatic drug (bDMARD).The trial also met key secondary end points including Psoriasis Area and Severity Index (PASI) 75 response (51.9% vs 7.1%; P <.0001), Health Assessment Questionnaire-Disability Index (HAQ-DI) score (-.39 vs -.22; P <.0001), 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) score (6.06 vs 3.71; P <.0001) and Minimal Disease Activity (MDA) response (19.0% vs 10.2%; P <.0001).3

HCPLive spoke with study investigator Philip Mease, MD, director of rheumatology research at Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, Seattle, to learn more about how the new data add to the field’s knowledge of deucravacitinib’s safety and efficacy for people with PsA and the potential the therapy may have in improving disease outcomes.

“It appears to have a more pristine safety profile, even [more so] than some of the JAK1 or JAK3 inhibitors. I think that patients will appreciate having a safe drug that can be used, especially early on, in PsA,” Mease said.

Relevant disclosures include AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead Sciences, Genentech, Janssen, Novartis, Pfizer Inc, Sun and UCB.

References

1. Kunzmann K. FDA Approves Deucravacitinib for Adults with Plaque Psoriasis. HCPLive. September 12, 2022. https://www.hcplive.com/view/fda-approves-deucravacitinib-adults-plaque-psoriasis

2. Bristol Myers Squibb’s Supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for the Treatment of Adults with Active Psoriatic Arthritis Accepted for Review Across Four Regions Globally. News release. Bristol Myers Squibb. July 21, 2025. https://news.bms.com/news/details/2025/Bristol-Myers-Squibbs-Supplemental-New-Drug-Application-sNDA-for-Sotyktu-deucravacitinib-for-the-Treatment-of-Adults-with-Active-Psoriatic-Arthritis-Accepted-for-Review-Across-Four-Regions-Globally/default.aspx

3. 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.