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: 1690

Apremilast Reduces Inflammation as Measured by MRI of the Hand in Patients with Psoriatic Arthritis: Primary Results from the Phase 4 MOSAIC Study

Mikkel Østergaard1, Walter P. Maksymowych2, Mikael Boesen3, Robert Lambert4, Guillermo Valenzuela5, Michael Bubb6, Olga Kubassova7, Jyotsna Reddy8, Stephen Colgan9, Yuri Klyachkin10, Cynthia Deignan11, Lihua Tang8, Maria Paris8 and Philip J. Mease12, 1Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet; University of Copenhagen, Copenhagen, Denmark, 2University of Alberta, Edmonton, AB, Canada, 3Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital, Naerum, Denmark, 4Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, AB, Canada, 5Integral Rheumatology & Immunology Specialists, Plantation, FL, 6University of Florida, Gainesville, FL, 7Image Analysis Group, Philadelphia, PA, 8Amgen, Inc., Thousand Oaks, CA, 9Amgen, Inc., Halton Hills, ON, Canada, 10Amgen, Inc., Lexington, KY, 11Amgen, Inc., Agoura Hills, CA, 12Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA

Meeting: ACR Convergence 2023

Keywords: autoimmune diseases, Imaging, Psoriatic arthritis

  • 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 13, 2023

Title: Abstracts: Spondyloarthritis Including Psoriatic Arthritis – Treatment II: PsA

Session Type: Abstract Session

Session Time: 4:00PM-5:30PM

Background/Purpose: PsA is characterized by inflammatory arthritis, enthesitis, dactylitis, and spondylitis. Apremilast (APR) is an oral immunomodulating phosphodiesterase-4 inhibitor approved for the treatment of PsA. Here, we evaluate the efficacy of APR 30 mg BID on inflammation measured by a dedicated MRI of the hand.

Methods: MOSAIC (NCT03783026) was a phase 4, multicenter, single-arm, open-label study in patients (pts) with active PsA (≥3 months but ≤5 years since diagnosis, meeting CASPAR criteria) evaluating APR as monotherapy or in combination with stable MTX. Pts were treated with APR for 48 weeks (wk) and had contrast-enhanced MRI of the hand performed at baseline (BL), Wk 24, and Wk 48. All images were read and adjudicated by 2 experienced readers blinded to clinical information and time of acquisition. The primary endpoint was change from BL in the composite score of hand bone marrow edema (BME), synovitis, and tenosynovitis in fingers 2–5, as assessed by the PsA MRI Score (PsAMRIS) at Wk 24. Total inflammation score, comprised of BME, synovitis, tenosynovitis, and periarticular inflammation in fingers, was also assessed. Structural progression determined by bone erosion and proliferation in fingers 2–5 was assessed by the total hand damage score. Subgroup analyses based on BL disease activity as measured by Clinical Disease Activity Index for PsA (cDAPSA) were performed for key endpoints.

Results: A total of 122 pts enrolled and received APR (mean age, 47 y; 55% female; and mean PsA duration, 1.9 y). The Full Analysis Set (FAS) included 98 pts evaluable for the primary endpoint and 94 were included in the per protocol (PP) set. The least-squares (LS) mean (95% CI) change from BL in the PsAMRIS (FAS) was -2.32 (-4.73, 0.09) at Wk 24 and -2.91 (-5.45, -0.37) at Wk 48 (Figure 1). In the PP set, the LS mean (95% CI) change from BL in the PsAMRIS at Wks 24 and 48 showed a significant reduction of disease activity (Figure 1). Significant improvements from BL were seen in total inflammation scores in the FAS (Figure 1). The total hand damage score showed no significant change from BL to Wk 48 (Figure 1). Pts also experienced significant improvements from BL in cDAPSA at Wks 24 and 48 (Figure 1). Subgroup analyses based on BL disease activity showed significant improvements from BL in inflammation in pts with moderate disease activity (ModDA;cDAPSA >13 to ≤27) and no significant change from BL in total damage. Though it was insignificant, pts with high disease activity (HDA; cDAPSA >27) did have improvement from BL in inflammation indices (Figure 2). No new safety signals were identified.

Conclusion: Pts with PsA treated with APR had improvements in both clinical indices and objective MRI indices of inflammation assessed by PsAMRIS in the target hand at Wk 24 and Wk 48, confirming an effect of APR on clinical and inflammatory manifestations of PsA. Pts with ModDA seemed to have greater improvement from BL in MRI inflammation scores than pts with HDA. No significant structural progression was observed. These results offer important insights on the effect of APR in PsA and highlight the value of using MRI and PsAMRIS as measures of inflammatory disease activity and change following treatment.

Supporting image 1

Change From Baseline in Imaging and Clinical Efficacy Endpoints Following Treatment With Apremilast

Supporting image 2

Change From Baseline in Imaging Endpoints by Disease Activity Status at Baseline (Subgroup Analyses)


Disclosures: M. Østergaard: AbbVie, 2, 5, 6, Amgen, 5, Boehringer-Ingelheim, 2, 6, Bristol-Myers Squibb(BMS), 2, 5, 6, Celgene, 2, 5, 6, Eli Lilly, 2, 6, Galapagos, 2, 6, Gilead, 2, 6, Hospira, 2, 6, Janssen, 2, 6, MEDAC, 6, Merck, 2, 5, 6, Novartis, 2, 5, 6, Novo Nordisk, 2, 6, Orion, 2, 6, Pfizer, 2, 6, Regeneron, 2, 6, Roche, 2, 6, Sandoz, 2, 6, Sanofi, 2, 6, UCB, 2, 6; W. Maksymowych: AbbVie, 2, 5, 6, BMS, 2, 6, Boehringer-Ingelheim, 2, CARE Arthritis Ltd, 4, CARE Arthritis Ltd., 4, Celgene, 2, 6, Eli Lilly, 2, 6, Galapagos, 2, 6, Gilead, 2, Janssen, 2, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, UCB, 2, 5, 6; M. Boesen: AbbVie, 2, 5, 6, Celgene, 2, 5, 6, Eli Lilly, 2, 6, Image Analysis Group, 2, 6, 11, Novartis, 2, 5, 6, Pfizer, 2, 6, UCB, 2, 6; R. Lambert: Calyx, 2, CARE Arthritis Limited, 2, Image Analysis Group, 2; G. Valenzuela: AbbVie, 2, Bristol-Myers Squibb, 12, Investigator, Celgene, 2, Eli Lilly, 2, Genentech, 2, 6, GlaxoSmithKlein(GSK), 2, Janssen, 2, Merck, 2, MLKCDT, 12, Investigator, Novartis, 2, Pfizer, 2, Regeneron, 2, Sanofi, 2, UCB, 2; M. Bubb: Amgen, 5, Bristol-Myers Squibb, 5, Eli Lilly, 5, Gilead, 5, GlaxoSmithKline, 5, Janssen, 5, Novartis, 5, Pfizer, 5, UCB, 5; O. Kubassova: Image Analysis Group, 3, 11; J. Reddy: Amgen, 3, 11; S. Colgan: Amgen, 3, 11; Y. Klyachkin: Amgen, 3, 11; C. Deignan: Amgen, 3, 11; L. Tang: Amgen, 3, 11; M. Paris: Amgen, 3, 11; P. Mease: AbbVie, 2, 5, 6, Acelyrin, 2, Aclaris, 2, Amgen, 2, 5, 6, Boehringer Ingelheim, 2, Bristol Myers Squibb, 2, 5, Eli Lilly, 2, 5, 6, Galapagos, 2, Gilead, 2, GlaxoSmithKline, 2, Inmagene, 2, Janssen, 2, 5, 6, MoonLake Pharma, 2, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Sun Pharma, 2, 5, UCB Pharma, 2, 5, 6, Ventyx, 2, Xinthera, 2.

To cite this abstract in AMA style:

Østergaard M, Maksymowych W, Boesen M, Lambert R, Valenzuela G, Bubb M, Kubassova O, Reddy J, Colgan S, Klyachkin Y, Deignan C, Tang L, Paris M, Mease P. Apremilast Reduces Inflammation as Measured by MRI of the Hand in Patients with Psoriatic Arthritis: Primary Results from the Phase 4 MOSAIC Study [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/apremilast-reduces-inflammation-as-measured-by-mri-of-the-hand-in-patients-with-psoriatic-arthritis-primary-results-from-the-phase-4-mosaic-study/. 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 2023

ACR Meeting Abstracts - https://acrabstracts.org/abstract/apremilast-reduces-inflammation-as-measured-by-mri-of-the-hand-in-patients-with-psoriatic-arthritis-primary-results-from-the-phase-4-mosaic-study/

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