POETYK PsA-2 design and 2-year efficacy results
Bristol Myers Squibb reported positive 2-year results from the Phase 3 POETYK PsA-2 open-label extension, showing durable efficacy and a consistent safety profile for deucravacitinib (Sotyktu) in adults with active psoriatic arthritis (PsA).
The oral tyrosine kinase 2 (TYK2) inhibitor became the first agent in its class approved for active PsA earlier in 2026, building on its existing plaque psoriasis indication. Longer-term extension data address a common gap in PsA trials, where durability beyond the initial treatment window often determines real-world utility.
"These longer-term results strengthen the evidence supporting Sotyktu as a durable oral option for managing key joint and skin manifestations, with a favorable safety profile," said Philip Mease, MD, director of rheumatology research, Providence Swedish Medical Center, and clinical professor, University of Washington School of Medicine, Seattle.
POETYK PsA-2 (NCT04908189) randomized 729 adults with active PsA who were bDMARD naive or had prior TNFα inhibitor exposure, meeting CASPAR criteria with at least 3 swollen and 3 tender joints. Patients received continuous deucravacitinib 6 mg once daily (n = 312), placebo with crossover to deucravacitinib at week 16 (n = 312), or an apremilast-to-deucravacitinib safety reference arm (n = 105). Patients completing the 52-week treatment period were eligible to enroll in an open-label extension (OLE) through week 156, and 245, 254 and 70 patients from each respective group entered the OLE.
Among patients treated continuously from baseline through the OLE, American College of Rheumatology (ACR) 20/50/70 response rates at week 104 were 76.2%, 52.6% and 34.6%, respectively, by observed analysis, and 65.3%, 44.9% and 29.4% by nonresponder imputation (NRI). Minimal disease activity (MDA) response rates were 51.2% (observed) and 43.7% (NRI). Among patients who switched from placebo to deucravacitinib at week 16, ACR 20/50/70 rates at week 104 were 76.9%, 54.6% and 37.7% (observed) and 69.3%, 49.2% and 33.9% (NRI), with MDA rates of 48.7% (observed) and 43.7% (NRI).
Key Facts
What did the POETYK PsA-2 open-label extension show for deucravacitinib?
Among patients treated continuously through 2 years, ACR20/50/70 response rates at week 104 were 76.2%, 52.6% and 34.6% by observed analysis, with responses maintained from week 52 through week 104.
Was deucravacitinib's safety profile consistent over 2 years in PsA?
Yes, safety through week 104 was consistent with the 52-week PsA-2 results and the long-term psoriasis safety database, with no new signals; the most common AEs were upper respiratory tract infection, nasopharyngitis and COVID-19.
What is deucravacitinib's approval status in psoriatic arthritis?
Deucravacitinib (Sotyktu) is FDA-approved for active psoriatic arthritis in adults, an indication granted earlier in 2026, in addition to its existing moderate-to-severe plaque psoriasis indication.
What was Deucravacitinib’s safety profile through week 104?
Clinical responses continued to improve from week 16 through week 52 and were maintained through week 104 across both treatment groups, according to the company. Safety outcomes through week 104 were consistent with the previously reported 52-week PsA-2 results and with the long-term safety profile observed across the 5-year deucravacitinib psoriasis program, with no new safety signals identified.
Among all patients with any deucravacitinib exposure through the 2-year cumulative period (n = 604), adverse events (AEs) occurred in 86.6%, serious AEs in 12.6% and AEs leading to discontinuation in 7.6%. The most common AEs were upper respiratory tract infection, nasopharyngitis and COVID-19.
"Following the approval of Sotyktu for adults with active PsA earlier this year, these results through 2 years of treatment in POETYK PsA-2 reinforce the durable efficacy and safety profile observed across our clinical program and the various subgroups assessed," said Liz Colston, MD, PhD, vice president and head of Immunology development, Bristol Myers Squibb.
Results from the OLE of the companion POETYK PsA-1 trial are expected at an upcoming medical meeting. The 2-year PsA-2 data were presented at the Congress of Clinical Rheumatology-West (CCR-West) in Huntington Beach, California, September 17-20, 2026.
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