Two-Year POETYK PsA-2 Data Show Durable Deucravacitinib Responses in Psoriatic Arthritis

Bristol Myers Squibb announced 2-year results from the phase 3 POETYK PsA-2 trial and its open-label extension showing sustained efficacy with deucravacitinib (Sotyktu) in adults with active psoriatic arthritis (PsA). Clinical responses improved through the first year of treatment and were maintained through week 104, according to data presented at the Congress of Clinical Rheumatology-West, held September 17 to 20, 2026, in Huntington Beach, California.

The findings provide longer-term follow-up for deucravacitinib following its 2026 FDA approval for adults with active PsA. The oral selective tyrosine kinase 2 (TYK2) inhibitor is administered at a dose of 6 mg once daily. The FDA approval was based on results from the phase 3 POETYK PsA-1 and POETYK PsA-2 trials.

Clinical Responses Maintained Through Week 104

Among patients who received deucravacitinib continuously from the beginning of POETYK PsA-2 through the open-label extension, American College of Rheumatology (ACR) 20, 50, and 70 response rates at week 104 were 76.2%, 52.6%, and 34.6%, respectively, in the observed analysis.

Using nonresponder imputation (NRI), corresponding ACR20, ACR50, and ACR70 response rates were 65.3%, 44.9%, and 29.4%, respectively. Minimal disease activity (MDA) was achieved by 51.2% of patients in the observed analysis and 43.7% using NRI.

Responses were similarly maintained among patients initially assigned to placebo who switched to deucravacitinib at week 16. At week 104, observed ACR20, ACR50, and ACR70 response rates in this group were 76.9%, 54.6%, and 37.7%, respectively. With NRI, response rates were 69.3%, 49.2%, and 33.9%.

MDA response rates among patients who crossed over from placebo were 48.7% in the observed analysis and 43.7% using NRI.

According to Bristol Myers Squibb, responses across these measures generally continued to improve between weeks 16 and 52 before being maintained through week 104.

“Psoriatic arthritis is a complex, chronic and often debilitating disease that can affect any part of the body, leaving patients in need of treatment options that can support symptom control beyond the initial months of therapy,” Philip Mease, MD, director of rheumatology research at Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, said in a news release.

Mease added that the longer-term findings provide additional evidence for deucravacitinib as an oral treatment targeting both joint and skin manifestations of PsA.

Safety Profile Remained Consistent at 2 Years

No new safety signals were identified through week 104, according to Bristol Myers Squibb. The company reported that the findings were consistent with previously reported 52-week POETYK PsA-2 results and the longer-term safety experience with deucravacitinib in its psoriasis clinical development program.

Among 604 patients with any exposure to deucravacitinib during the cumulative 2-year period, 86.6% experienced an adverse event (AE), 12.6% experienced a serious AE, and 7.6% discontinued treatment because of an AE.

The most frequently reported AEs were upper respiratory tract infection, nasopharyngitis, and COVID-19.

The current US prescribing information for deucravacitinib includes warnings and precautions regarding hypersensitivity reactions, infections, tuberculosis, malignancies, rhabdomyolysis and elevated creatine phosphokinase, laboratory abnormalities, immunizations, and potential risks related to JAK inhibition.

POETYK PsA-2 Trial Design

POETYK PsA-2 is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluating deucravacitinib in adults with active PsA who were either biologic disease-modifying antirheumatic drug (bDMARD) naïve or had previously received a tumor necrosis factor α inhibitor.

Participants met Classification Criteria for Psoriatic Arthritis (CASPAR), had at least 3 swollen and 3 tender joints, and had active plaque psoriasis or a documented history of the disease.

The study included a placebo-controlled period through week 16, followed by reallocation and continued active treatment through week 52. Patients completing the initial 52-week study could enter an open-label extension and receive deucravacitinib 6 mg once daily through week 156.

The primary endpoint was the proportion of patients achieving ACR20 at week 16. The FDA-approved labeling reports that 54% of patients receiving deucravacitinib in POETYK PsA-2 achieved ACR20 at week 16 compared with 39% receiving placebo.

Overall, 729 patients were randomized in POETYK PsA-2, including 312 to continuous deucravacitinib, 312 to placebo followed by deucravacitinib, and 105 to an apremilast safety reference arm followed by deucravacitinib. Of these groups, 245, 254, and 70 patients, respectively, entered the optional open-label extension.

Expanding Long-Term Data for Deucravacitinib in PsA

Deucravacitinib selectively targets TYK2, which mediates signaling involving interleukin (IL)-23, IL-12, and type I interferons. Unlike Janus kinase (JAK) inhibitors, deucravacitinib binds to the regulatory domain of TYK2 and, at therapeutic concentrations, does not inhibit JAK1, JAK2, or JAK3.

The FDA expanded the indication for deucravacitinib to include adults with active PsA in March 2026. The treatment was originally approved in 2022 for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The newly reported POETYK PsA-2 findings extend the available efficacy and safety data to 2 years. Bristol Myers Squibb also reported that results from the open-label extension of POETYK PsA-1 are expected to be presented at a future medical meeting.

References

1. Bristol Myers Squibb. Bristol Myers Squibb presents Sotyktu (deucravacitinib) data showing durable efficacy, consistent safety in adults with psoriatic arthritis over two years. Published September 17, 2026. https://news.bms.com/news/corporate-financial/2026/Bristol-Myers-Squibb-Presents-Sotyktu-deucravacitinib-Data-Showing-Durable-Efficacy-Consistent-Safety-in-Adults-with-Psoriatic-Arthritis-Over-Two-Years/default.aspx
2. US Food and Drug Administration. Sotyktu (deucravacitinib) tablets: prescribing information. Revised 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214958s006sdn685lbl.pdf
3. US Food and Drug Administration. Sotyktu (deucravacitinib) supplemental approval. 2026. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214958Orig1s006ltr.pdf