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: 2132

Safety of Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor: As Assessed by Laboratory Parameters – Results from a Phase 2 Trial in Psoriatic Arthritis and 2 Phase 3 Trials in Psoriasis

Roy Fleischmann1, Diamant Thaci2, Melinda Gooderham3, Bruce Strober4, Neil J. Korman5, Subhashis Banerjee6, Tom Lehman6, Miroslawa Nowak6, Antoine Sreih7, Akimichi Morita8 and Philip J Mease9, 1Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, 2Institute and Comprehensive Center for Inflammation Medicine, University Hospital of Lübeck, Lübeck, Germany, 3SKiN Centre for Dermatology, Queen’s University, Probity Medical Research, Peterborough, Canada, 4Yale University, New Haven, CT; Central Connecticut Dermatology Research, Cromwell, CT, 5Case Western Reserve University and University Hospitals, Cleveland, OH, 6Bristol Myers Squibb, Princeton, NJ, 7Bristol Myers Squibb, Philadelphia, PA, 8Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, 9Swedish Medical Center/Providence St. Joseph Health, Seattle, WA

Meeting: ACR Convergence 2022

Keywords: Psoriatic arthritis, spondyloarthritis

  • Tweet
  • Email
  • 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: Deucravacitinib (DEUC) is a novel, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action distinct from Janus kinase (JAK) 1/2/3 inhibitors. DEUC mediates signaling of key cytokines in PsA and psoriasis (PsO). DEUC was well tolerated and efficacious vs placebo (PBO) in a phase 2 trial in patients with PsA,1 and vs PBO or apremilast in 2 phase 3 PsO trials.2 The current analysis, conducted using data from the first 16 weeks (PBO-controlled phase) of the phase 2 PsA trial and pooled data from the 2 phase 3 PsO trials, assessed the effects of DEUC on multiple laboratory parameters, which are known to change on treatment with JAK 1/2/3 inhibitors.

Methods: The phase 2 double-blind PsA trial randomized patients (n = 203) 1:1:1 to PBO, DEUC 6 mg once daily (QD), or 12 mg QD. The phase 3 double-blind PsO trials, POETYK PSO-1 and POETYK PSO-2, randomized patients (n = 666 and 1020, respectively) 1:2:1 to PBO, DEUC 6 mg QD, or apremilast 30 mg twice daily. Changes from baseline in hematologic (neutrophils, lymphocytes, platelets, hemoglobin) and chemistry (cholesterol, triglycerides, alanine aminotransferase [ALT], aspartate aminotransferase [AST], and creatine phosphokinase [CPK]) parameters were evaluated. Shifts in Common Terminology Criteria for Adverse Events (CTCAE; version 5.0) severity grades ≥ 3 of laboratory abnormalities were assessed.

Results: In the PsA trial, 65% of patients were on concomitant conventional synthetic DMARDs (csDMARDs) and 54.7% of patients were on methotrexate. The vast majority of patients continued to have laboratory parameters within normal range throughout the 3 trials in PsO and PsA. No clinically meaningful changes from baseline were observed in any hematology, chemistry, or lipid laboratory parameters in patients treated with DEUC, PBO, or apremilast. Rates of CTCAE grades 3 and 4 were rare (≤ 1 patient) and similar across DEUC-, PBO-, and apremilast-treated patients for the following parameters: lymphocytes, neutrophils, platelets, hemoglobin, AST, ALT, and cholesterol (Table). Shifts to CTCAE grades ≥ 3 in triglycerides and CPK were infrequent and generally comparable across treatment arms.

Conclusion: DEUC treatment did not result in clinically meaningful mean changes from baseline in laboratory parameters over 16 weeks in the PBO-controlled portion of the phase 2 trial in PsA, despite two-thirds of patients receiving concomitant csDMARDs, and in 2 large phase 3 trials in PsO. Effects on hematological, hepatic, CPK, and cholesterol laboratory parameters characteristic of JAK 1/2/3 inhibitors were generally not observed over 16 weeks of DEUC exposure at doses up to 12 mg QD and in the presence of background csDMARDs.

References
1. Mease PJ, et al. Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II 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.

Supporting image 1


Disclosures: R. Fleischmann, AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Galvani, GlaxoSmithKlein (GSK), Janssen, Pfizer, Gilead, UCB, Novartis, Arthrosi, AstraZeneca, Flexion, Genentech, Horizon, Selecta, Viela, Vorso, Vyne; D. Thaci, AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi-Genzyme, UCB Pharma, Celltrion, Morphosis, Sun Pharma; M. Gooderham, AbbVie, Akros, Amgen, Anaptys Bio, Arcutis, Aslan, Bausch, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermira, Dermavant, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Janssen, Kyowa Kirin, Leo Pharma, Medimmune, Merck, Novartis, Pfizer, Regeneron, Sanofi Genzyme, SUN Pharma, UCB; B. Strober, AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Eli Lilly, Meiji Seika Pharma, Novartis, Pfizer, UCB Pharma, Sun Pharma, Regeneron, Dermira, Leo Pharma, Inc, Arcutis, Arena, Aristea Therapeutics, Dermavant, Equillium, Mindera Health, Ortho Dermatologics, Sanofi-Genzyme, CorEvitas (formerly Corrona) Psoriasis Registry, Cara Therapeutics, Journal of Psoriasis and Psoriatic Arthritis, Alumis; N. Korman, AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, Principia, Regeneron, Sanofi-Genzyme, Sun Pharma, UCB, Amgen, Argenx, Chemocentryx, Galderma, Kyowa Hakko Kirin, Menlo, Prothena, Rhizen, Syntimmune, Trevi, Xbiotech; S. Banerjee, Bristol Myers Squibb; T. Lehman, Bristol Myers Squibb; M. Nowak, Bristol Myers Squibb; A. Sreih, Bristol Myers Squibb; A. Morita, AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Eisai, Janssen, Kyowa Hakko Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe, Nichi-Iko, Nippon Kayaku, Novartis, Pfizer, Sun Pharmaceutical Industries, Taiho Pharmaceutical, Torii Pharmaceutical, Ushio, UCB Pharma; P. Mease, AbbVie, Amgen, Janssen, Novartis, Pfizer Inc, UCB, Sun Pharma, Eli Lilly, Bristol-Myers Squibb(BMS), Celgene, Genentech.

To cite this abstract in AMA style:

Fleischmann R, Thaci D, Gooderham M, Strober B, Korman N, Banerjee S, Lehman T, Nowak M, Sreih A, Morita A, Mease P. Safety of Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor: As Assessed by Laboratory Parameters – Results from a Phase 2 Trial in Psoriatic Arthritis and 2 Phase 3 Trials in Psoriasis [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/safety-of-deucravacitinib-an-oral-selective-tyrosine-kinase-2-inhibitor-as-assessed-by-laboratory-parameters-results-from-a-phase-2-trial-in-psoriatic-arthritis-and-2-phase-3-trials-in-ps/. Accessed .
  • Tweet
  • Email
  • Print

« Back to ACR Convergence 2022

ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-of-deucravacitinib-an-oral-selective-tyrosine-kinase-2-inhibitor-as-assessed-by-laboratory-parameters-results-from-a-phase-2-trial-in-psoriatic-arthritis-and-2-phase-3-trials-in-ps/

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