ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 2134

Deucravacitinib Long-term Efficacy and Safety in Plaque Psoriasis: 2-Year Results from the Phase 3 POETYK PSO Program

Richard Warren1, Howard Sofen2, Shinichi Imafuku3, Jacek C. Szepietowski4, Andrew Blauvelt5, Lynda Spelman6, Jessica Toms7, Alex Buck8, Subhashis Banerjee7 and Alan Menter9, 1The University of Manchester, Manchester, United Kingdom, 2UCLA School of Medicine, Los Angeles, CA, 3Fukuoka University Hospital, Fukuoka, Japan, 4Wroclaw Medical University, Wroclaw, Poland, 5Oregon Medical Research Center, Portland, OR, USA, Portland, OR, 6Veracity Clinical Research, Woolloongabba, Australia, 7Bristol Myers Squibb, Princeton, NJ, 8Bristol Myers Squibb; Cytel Inc, Princeton, 9Baylor University Medical Center, Dallas, TX

Meeting: ACR Convergence 2022

Keywords: Psoriatic arthritis, spondyloarthritis

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print
Session Information

Date: Monday, November 14, 2022

Title: Spondyloarthritis Including PsA – Treatment Poster III: PsA

Session Type: Poster Session D

Session Time: 1:00PM-3:00PM

Background/Purpose: Tyrosine kinase 2 (TYK2) is an intracellular kinase that mediates signalling of key cytokines (eg, IL-23 and Type I IFN) involved in the pathogenesis of immune-mediated diseases including plaque psoriasis and PsA. Deucravacitinib is an oral, selective, allosteric TYK2 inhibitor that achieves high selectivity by uniquely binding to the regulatory domain of the enzyme, rather than to the more conserved active domain. Deucravacitinib showed superior efficacy compared with placebo at 16 weeks in a phase 2 trial in patients with PsA.1 The efficacy and tolerability of deucravacitinib in patients with moderate to severe psoriasis were previously demonstrated in 2 pivotal, phase 3, double-blind trials, POETYK PSO-1 and PSO-2.2 The long-term efficacy and safety of deucravacitinib were assessed in patients with psoriasis enrolled in the phase 3, double-blind POETYK PSO-1 and PSO-2 trials and the open-label long-term extension (LTE) trial.

Methods: The 52-week PSO-1 and PSO-2 trials (NCT03624127 and NCT03611751) randomized patients with moderate to severe plaque psoriasis 2:1:1 to deucravacitinib 6 mg once daily, placebo, or apremilast 30 mg twice daily. Patients completing PSO-1 or PSO-2 could then enroll in the LTE trial (NCT04036435) and receive open-label deucravacitinib 6 mg once daily. All 3 trials overlapped with the COVID-19 pandemic. Efficacy outcomes are reported for patients (n = 1221) who received ≥1 dose of deucravacitinib in the LTE using a modified nonresponder imputation approach. Safety data are reported for patients who received ≥ 1 dose of deucravacitinib during the controlled weeks 0–52 period (n = 1364; 969.0 person-years [PY]) and during the cumulative PSO-1/PSO-2 and LTE period (n = 1519; 2482.0 PY).

Results: Demographic and disease characteristics were balanced across treatment groups; mean age at disease onset was 28.6 years, mean disease duration was 18.9 years at last visit of the parent trials, and 18.0% of patients had PsA at baseline of the parent trials. At enrollment in the LTE trial, response rates for ≥ 75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician’s Global Assessment score of 0 or 1 (sPGA 0/1) were 71.3% and 56.3%, respectively, and were maintained through LTE week 60 (PASI 75, 75.7%; sPGA 0/1, 57.1%). Exposure-adjusted incidence rates per 100 PY were similar in the controlled (weeks 0‒52) and cumulative (PSO-1, PSO-2, and LTE) trial periods for adverse events (229.2 and 154.4, respectively), serious adverse events (5.7 and 6.1), discontinuations (4.4 and 2.8), deaths (0.2 and 0.4), herpes zoster (0.9 and 0.7), malignancies (1.0 and 0.9), major adverse cardiovascular events (0.3 and 0.4), and venous thromboembolism (0.1 and 0.1).

Conclusion: Deucravacitinib demonstrated persistent efficacy and consistent safety profiles in patients with psoriasis for up to 2 years after initial randomization in the POETYK PSO‑1, PSO-2, and LTE trials.

References
1. Mease PJ, et al. Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase 2 trial in psoriatic arthritis. Ann Rheum Dis. 2022;81:815-822.
2. Armstrong A, et al. Presented at American Academy of Dermatology Virtual Meeting Experience 2021; April 23-25, 2021.


Disclosures: R. Warren, AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, GSK, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, UCB Pharma, DiCE, Union; H. Sofen, AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen, Leo Pharma, Novartis, Sun Pharma; S. Imafuku, AbbVie, Eisai, Janssen, Kyowa Kirin, Leo Pharma, Maruho, Sun Pharma, Taiho Yakuhin, Tanabe Mitsubishi, Torii Yakuhin, Amgen, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, Novartis, UCB; J. Szepietowski, AbbVie, Leo Pharma, Novartis, Pierre-Fabre, Sanofi Genzyme, Trevi, Eli Lilly, Janssen-Cilag, Amgen, Bristol Myers Squibb, Galapagos,, Galderma, Incyte, InfraRX, Manlo Therapeutics, Merck, Novartis, Pfizer, Regeneron, UCB; A. Blauvelt, AbbVie, Abcentra, Aligos, Almirall, Amgen, Arcutis, Arena, Aslan, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Evommune, Forte, Galderma, Incyte, Janssen, Landos, Leo Pharma, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, UCB Pharma, EcoR1, Vibliome; L. Spelman, AbbVie, Amgen, Anacor, Ascend, Astellas, AstraZeneca, Blaze Bioscience, Boehringer Ingelheim, Botanix, Bristol Myers Squibb, Celgene, Dermira, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Hexima, Janssen, Leo Pharma, Mayne Pharma, MedImmune, Merck, Merck-Serono, Novartis, Otsuka, Pfizer, Phosphagenics, Photon MD, Regeneron, Roche, Samumed, Sanofi Genzyme, SHR, Sun Pharma ANZ, Trius, UCB, Zai Lab; J. Toms, Bristol Myers Squibb; A. Buck, Bristol Myers Squibb; S. Banerjee, Bristol Myers Squibb; A. Menter, Abbott Labs, Amgen, Boehringer Ingelheim, Janssen Biotech, Leo Pharma, Eli Lilly, Novartis, Sun Pharma, UCB, Celgene, Merck.

To cite this abstract in AMA style:

Warren R, Sofen H, Imafuku S, Szepietowski J, Blauvelt A, Spelman L, Toms J, Buck A, Banerjee S, Menter A. Deucravacitinib Long-term Efficacy and Safety in Plaque Psoriasis: 2-Year Results from the Phase 3 POETYK PSO Program [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/deucravacitinib-long-term-efficacy-and-safety-in-plaque-psoriasis-2-year-results-from-the-phase-3-poetyk-pso-program/. Accessed .
  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

« Back to ACR Convergence 2022

ACR Meeting Abstracts - https://acrabstracts.org/abstract/deucravacitinib-long-term-efficacy-and-safety-in-plaque-psoriasis-2-year-results-from-the-phase-3-poetyk-pso-program/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology