TYK2 Inhibitor Deucravacitinib up for FDA Review for Psoriatic Arthritis

The FDA has accepted Bristol Myers Squibb’s supplemental New Drug Application (sNDA) for deucravacitinib for treating adults with active psoriatic arthritis (PsA) with a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.1

“All in all, this grounds us that this very specific tyrosine kinase 2 (TYK2) inhibition capability is going to be an addition to our mechanisms that we can choose from for treating PsA, and because the safety profile was so pristine, there wasn't much to comment on in terms of serious infection or malignancy or thromboembolic events, etc,” primary 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, told HCPLive. “It appears to have a more pristine safety profile, even than some of the JAK, JAK1 or JAK3 inhibitors. I think that patients will appreciate having a safe drug that can be used, especially early on, in PsA.”

Deucravacitinib is an oral, selective TYK2 inhibitor and could be the first TYK2 inhibitor approved for the treatment of PsA. It has also received sNDA acceptances by China’s Center for Drug Evaluation of National Medical Products Administration and Japan's Ministry of Health, Labour and Welfare for Sotyktu for PsA and its Type II variation application has been validated by the European Medicines Agency for PsA as well. The therapy is currently approved under the name Sotyktu for treating adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.2

The sNDA is based off of positive findings from the pivotal POETYK PsA-1 and POETYK PsA-2 trials. Recent data from POETYK PsA-1 presented at the European Alliance of Associations for Rheumatology (EULAR) Congress in Barcelona, Spain, taking place June 11-14, 2025, demonstrated that it met its primary endpoint of achieving ACR20 response at week 16 compared to placebo in adults with active PsA who were not previously treated with a biologic disease-modifying anti-rheumatic drug (bDMARD).3

Mease and colleagues found that 54.2% of the deucravacitinib group achieved ACR20 response at week 16 compared to 34.1% of the placebo group (P <.0001), meeting the trial’s primary end point. 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

Investigators also observed nominally significant improvements in ACR50 (24.7% vs 13.5%; P = .0002), ACR70 (11.6% vs 5.4%; P = .0039), Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) score (4.6 vs 2.0; P <.0001), 28-Joint Disease Activity Score-C- Reactive Protein (DAS28-CRP) score (-1.33 vs -.83; P <.0001) and dactylitis resolution pooled analysis (57.6% vs 44.1%; P = .01), as well as an inhibition of radiographic progression of PsA.3

POETYK PsA-1 did not identify any new safety signals and the safety profile of deucravacitinib was similar as that in the Phase 3 POETYK PsA-2 trial and the Phase 3 moderate-to-severe plaque psoriasis (PsO) clinical trials. The most frequent adverse event (AE) in both the Sotyktu and placebo arms was upper respiratory tract infection (5.1% versus 3.0%, respectively). Serious AEs (1.8% versus 2.4%, respectively) and AEs that led to discontinuation (2.4% versus 1.8%, respectively) were infrequent though Week 16.3

“There is a significant need for additional oral treatments for individuals living with psoriatic arthritis, and today’s announcement brings us one step closer to bringing Sotyktu to these patients,” Roland Chen, MD, Senior Vice President, Drug Development, Immunology and Cardiovascular, Bristol Myers Squibb, said in a statement.1 “We are eager to continue conversations with the FDA and other global regulatory bodies with the goal of including Sotyktu as a differentiated, first-line, advanced systemic treatment option for psoriatic arthritis, while we pioneer research of this novel molecule in other severe rheumatic conditions.”

REFERENCES

1. 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

2. 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

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.