Oral Treatment for PsA Inches Closer to FDA Approval

In July, the U.S. Food & Drug administration (FDA) accepted a supplemental New Drug Application (NDA) for deucravacitinib (Sotyktu) tablets for the treatment of adults with active psoriatic arthritis (PsA). The application has a March 6, 2026, Prescription Drug User Fee Act goal date for review.¹ If approved, deucravacitinib will become the first in a new class of agents available for the treatment of patients with PsA. 

Deucravacitinib was initially approved by the FDA in September 2022 for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.² The agent selectively targets tyrosine kinase 2 (TYK2) and inhibits signaling of interleukin (IL) 23, IL-12 and type 1 interferons, which are involved in the pathogenesis of multiple immune-mediated diseases, including plaque psoriasis and PsA. Deucravacitinib is a selective, allosteric TYK2 inhibitor.³

The Research

This supplemental NDA is based on the results of the phase 3 POETYK PsA-1 (NCT04908202) and POETYK PsA-2 (NCT04908189) studies on the safety and efficacy of deucravacitinib conducted in adults with active PsA.^4,5 In these clinical trials, more patients treated with deucravacitinib achieved an ACR20 response at week 16 than patients who received a placebo, which was considered statistically significant. An ACR20 response is at least a 20% improvement in signs and symptoms of disease. In POETYK PsA-1, the ACR 20 response rates at week 16 for patients treated with deucravacitinib was 54.2% vs. 34.1% for those who received placebo (P<0.0001). In POETYK PsA-2, the ACR 20 response rates at week 16 for patients receiving deucravacitinib compared with those receiving placebo were 54.2% and 39.4% (P=0.0002), respectively.

Additionally, data from POETYK PsA-2 reported outcomes through week 52 of treatment. The study demonstrated the clinical response was not just maintained but increased.

No new safety signals were identified in the studies. These findings were consistent with the safety profile of deucravacitinib from clinical trials in patients with moderate to severe plaque psoriasis and a phase 2 clinical trial in patients with PsA.⁶

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

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 Co. 2025 Jul 21.
2. New drug approval letter: Sotyktu (deucravacitinib) tablets. U.S. Food & Drug Administration. 2022 Sep 9.
3. Highlights of prescribing information: Sotyktu (deucravacitinib) tablets for oral use. U.S. Food & Drug Administration. 2022 Sep 9.
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 [NCT04908202]. ClinicalTrials.gov. 2024 Sep 27.
5. 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 [NCT04908189]. ClinicalTrials.gov. 2024 Nov 1.
6. Bristol Myers Squibb announces positive topline results from two pivotal phase 3 trials evaluating Sotyktu (deucravacitinib) in adults with psoriatic arthritis [news release]. Bristol Myers Squibb Co. 2024 Dec 23.