Deucravacitinib has favorable safety, sustained efficacy through 52 weeks in adults with active psoriatic arthritis, phase 3 data show
Presenter: Philip J. Mease, MD, Director, Rheumatology Research, Providence Swedish Medical Center and Clinical Professor, University of Washington, Seattle
Efficacy and safety of deucravacitinib up to week 52: a multicenter, randomized, double-blind, placebo-controlled, phase 3 study in patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drugs. Abstract LB20. Presented October 29, 2025.
Deucravacitinib, an oral psoriasis treatment, has demonstrated sustained efficacy through 52 weeks of treatment in adults with active psoriatic arthritis, according to phase 3 trial results presented at ACR Convergence 2025.
In a late-breaking abstract session, Philip J. Mease, MD, reported that deucravacitinib was efficacious based on clinical response, inhibition of radiographic progression, and patient-reported outcomes in the POETYK PsA-1 study, a global, randomized, double-blind, placebo-controlled trial.
Outcomes continued to improve after week 16 of treatment in POETYK PsA-1, and were durable through week 52, according to the report.
“In multiple measures of efficacy in various clinical domains, inflammatory arthritis, psoriasis, enthesitis, dactylitis, physical function, fatigue, and inhibition of structural damage progression, deucravacitinib-treated patients demonstrated sustained, if not improved, responses over 52 weeks,” Dr. Mease said in an interview.
Safety through week 52 was reported to be consistent with the known profile of deucravacitinib, an oral tyrosine kinase 2 inhibitor that was approved by the US Food and Drug Administration (FDA) in 2022 for the treatment of adults with moderate-to-severe plaque psoriasis.
Data were also consistent with findings from the phase 3 POETYK PsA-2 study, reported earlier this year, according to Dr. Mease and co-investigators.
Altogether, investigators said, these data reinforce the efficacy and favorable safety profile of deucravacitinib, the first selective tyrosine kinase 2 inhibitor to be evaluated for treating psoriatic arthritis.
In July 2025, the FDA accepted a supplemental New Drug Application for deucravacitinib as a treatment for adults with active psoriatic arthritis.
“These data support the application for deucravacitinib to be approved for psoriatic arthritis, both in terms of efficacy as well as durability of effect,” Dr. Mease said. “Having an additional unique oral treatment option for psoriatic arthritis is important both as a safe and effective medicine to be used early in the treatment course, as well as in patients who have lost effect from previous treatments, later in the treatment course, is a welcome addition to our treatment armamentarium.”
The POETYK PsA-1 study included adult patients with active psoriatic arthritis who had not yet received any biologic disease-modifying antirheumatic drugs. A total of 670 patients were randomized to receive deucravacitinib 6 mg per day or placebo for 16 weeks. Then, from week 16 through week 52, patients in both groups received deucravacitinib 6 mg per day.
The primary endpoint was the proportion of patients achieving 20% improvement in symptoms by the American College of Rheumatology criteria (ACR 20) at week 16. As previously reported, this primary endpoint was met, with 54.2% of deucravacitinib-treated patients achieving ACR20, compared to 34.1% for placebo (P < .0001).
Responses continued to improve through week 24, and were maintained through week 52, Dr. Mease reported at ACR Convergence 2025.
At week 52, ACR 20 responses were seen in 63.1% of patients who had received deucravacitinib for the full study duration, and 60.8% for those switched from placebo to deucravacitinib, data show.
Clinical responses and patient-reported outcomes, met at week 16, continued to improve, he added, and were maintained through week 52 with deucravacitinib. Inhibition of radiographic progression was sustained through week 52, and those patients initially randomized to placebo had reduced radiographic progression after switching to deucravacitinib.
There were few serious adverse events or discontinuations due to adverse events, no new safety signals, and no deaths, investigators said, as well as no new safety signals related to adjudicated major adverse cardiovascular events, venous thromboembolism, or opportunistic infections.
In the interview, Dr. Mease said he anticipated using deucravacitinib in patients with newly diagnosed psoriatic arthritis patients seeking a safe oral treatment option with demonstrated efficacy in multiple clinical domains of psoriatic arthritis and can inhibit structural damage progression.
“Patients and clinicians appreciate the reassurance that a drug not only helps current signs and symptoms, but also can inhibit long-term damage accrual in joints,” Dr. Mease said. “Similarly, it is important for patients and clinicians to know that issues that are important in patient’s day to day lives—pain, fatigue, physical function, quality of life—can be discernably improved in both the short and long run.”
Disclosures
Philip J. Mease, MD, reported research grants, consultation fees, and/or speaker honoraria from Abbvie, Amgen, Astra Zeneca, Biogen, Bristol Myers, Century, Cullinan, Eli Lilly, Inmagene, Johnson & Johnson, Merck, Moonlake Pharma, Novartis, Oruka, Pfizer, Spyre, SUN Pharma, Takeda, and UCB.
References
van der Heijde D, Mease P, Paul C, et al. Efficacy and safety of deucravacitinib up to week 52: a multicenter, randomized, double-blind, placebo-controlled, phase 3 study in patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drugs [abstract]. Arthritis Rheumatol 2025; 77 (suppl 9). https://acrabstracts.org/abstract/efficacy-and-safety-of-deucravacitinib-up-to-week-52-a-multicenter-randomized-double-blind-placebo-controlled-phase-3-study-in-patients-with-active-psoriatic-arthritis-who-are-naive-to-biologic-d/. Accessed October 29, 2025.
van der Heijde D, Mease P, Paul C, et al. Efficacy and safety of deucravacitinib up to week 16 from POETYK PsA-1: a multicenter, randomized, double-blind, placebo-controlled, phase 3 study in patients with active psoriatic arthritis [abstract]. Ann Rheum Dis 2025; 84(supp 1):313–314. https://ard.eular.org/article/S0003-4967(25)01421-9/abstract. Accessed October 29, 2025.
Kang J. Deucravacitinib under review for active psoriatic arthritis. Rheumatology Advisor. Published July 25, 2025. Accessed October 29, 2025. https://www.rheumatologyadvisor.com/news/deucravacitinib-under-review-for-active-psoriatic-arthritis/