Bristol Myers Squibb unveils two year data showing durable efficacy and consistent safety for Sotyktu in adults with psoriatic arthritis

Results from the POETYK PsA-2 open-label extension showed strong response rates among patients treated with Sotyktu, with clinical responses continuing to build through year one and holding steady through year two

Two year data add to the established efficacy and safety profile of Sotyktu, the only approved tyrosine kinase 2 inhibitor for adults with psoriatic arthritis

Bristol Myers Squibb announced positive results spanning two years of treatment from the Phase 3 POETYK PsA-2 study, including its open-label extension, demonstrating durable efficacy and a consistent safety profile for Sotyktu (deucravacitinib) in adults with active psoriatic arthritis. The findings are being presented at the Congress of Clinical Rheumatology – West in Huntington Beach, California, running September 17 to 20, 2026.

Among patients who entered the open-label extension, Sotyktu showed durable efficacy, with clinical responses continuing to improve from week 16 through week 52 and remaining steady through week 104. Responses were strong across key clinical efficacy measures, including American College of Rheumatology 20/50/70 criteria and Minimal Disease Activity, both for patients who received Sotyktu continuously from the start of the Phase 3 study through the extension and for patients who switched from placebo to Sotyktu at week 16 and continued treatment through the remainder of the study and extension.

Among patients treated with Sotyktu continuously from the beginning of the Phase 3 study through the extension, ACR 20/50/70 response rates at week 104 reached 76.2 percent, 52.6 percent, and 34.6 percent respectively, based on observed data, and 65.3 percent, 44.9 percent, and 29.4 percent respectively using nonresponder imputation. Minimal Disease Activity response rates were 51.2 percent under observed analysis and 43.7 percent under nonresponder imputation.

Among patients who switched from placebo to Sotyktu at week 16 and continued treatment through the extension, ACR 20/50/70 response rates at week 104 reached 76.9 percent, 54.6 percent, and 37.7 percent under observed analysis, and 69.3 percent, 49.2 percent, and 33.9 percent under nonresponder imputation. Minimal Disease Activity response rates for this group were 48.7 percent under observed analysis and 43.7 percent under nonresponder imputation.

Philip Mease, MD, director of rheumatology research at Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine in Seattle, said psoriatic arthritis is a complex, chronic condition that can be deeply debilitating and can affect any part of the body, leaving patients in need of treatment options capable of sustaining symptom control well beyond the first few months of therapy. He said these longer term results strengthen the case for Sotyktu as a durable oral option for managing key joint and skin symptoms, backed by a favorable safety profile.

The results also showed that Sotyktu remained well tolerated through week 104. Safety outcomes were consistent with previously reported results from the PsA-2 study at 52 weeks and with Sotyktu’s established long term safety profile observed across its five year psoriasis clinical program, with no new safety signals identified. Among patients with any exposure to Sotyktu across the two year cumulative period, adverse events occurred in 86.6 percent of 604 patients, serious adverse events in 12.6 percent, and adverse events leading to discontinuation in 7.6 percent. The most common adverse events were upper respiratory tract infection, nasopharyngitis, and COVID-19.

Liz Colston, MD, PhD, vice president and head of immunology development at Bristol Myers Squibb, said that following the earlier approval of Sotyktu for adults with active psoriatic arthritis, these two year results from POETYK PsA-2 reinforce the durable efficacy and safety profile observed throughout the company’s clinical program and across the various subgroups studied. She said the positive data deepen the company’s understanding of Sotyktu in psoriatic arthritis and strengthen confidence in its potential role in addressing the needs of people living with chronic rheumatic diseases.

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Related Topics and Keywords

Bristol-Myers Squibb, psoriatic arthritis, Sotyktu (deucravacitinib)