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: 1810

Rheumatic Toxicities Associated with Immune Checkpoint Inhibitors: An Observational, Retrospective, Pharmacovigilance Study

Céline Anquetil1, Olivier Benveniste 1, Javid ‎ Moslehi 2, Douglas Johnson 2, Bénédicte lebrun-vignes 1, Olivier Lambotte 3, Joe-Elie Selam 4, Jean-Philippe Spano 5 and Yves Allenbach 1, 1Sorbonne Université, Paris, France, 2Vanderbilt, Nashville, 3APHP Médecine Interne/Immunologie Clinique, Hôpital Bicêtre, Paris, France. Université Paris Sud 11 – INSERM U1184 - CEA, Immunology of Viral Infections and Autoimmune Diseases, IDMIT Department, IBFJ, Fontenay-aux-Roses & Le Kremlin-Bicêtre, France., Paris, France, 4Sorbonne université, Paris, 5Sorbonne Université, Paris, French Guiana

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Adverse events, Auto-immunity, biologic drugs and drug toxicity, Cancer treatments

  • Tweet
  • Email
  • Print
Session Information

Date: Monday, November 11, 2019

Title: 4M091: Miscellaneous Rheumatic & Inflammatory Disease II: Checkpoint Inhibitors-Induced & Other Rheumatic Conditions (1806–1811)

Session Type: ACR Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose: Monoclonal antibodies targeting co-inhibitory immune checkpoints (PD-1/PDL1 axis or CTLA-4) showed unprecedented clinical activity in several types of cancer by restoring antitumor immune responses. We recently described that vasculitis (giant cell arteritis) was a rheumatic immune-related adverse event (irAE) but the description of other rheumatic adverse events remains sparse.

Methods: Using WHO’s global database of individual case safety reports, we compared rheumatic adverse events reporting in immune checkpoint inhibitors (ICI) exposed patients with the reporting in the full database. All rheumatic irAEs (except vasculitis) were included (according to the Medical Dictionary for Regulatory Activities). The association between ICI and rheumatic adverse events was analyzed using the reporting odds ratio (ROR) and the information component (IC: an indicator value for disproportionate reporting observed vs expected values). A positive IC025 (the lower end of the IC 95% credibility interval) is considered to be significant.

Results: We identified 54,416 adverse events reported in patients treated with ICI (14,988,450 adverse events reported in patients treated with any drugs, full database since 2008). Compared to the full database, ICI treatment was associated with higher reporting of arthritis (121,811 reports for the full database vs 606 for ICI, ROR 1.4 [1.3-1.5]; IC025 0.34), myositis (26,722 vs 465, ROR 4.9 [4.5-5.4]; IC025 2.12), sarcoidosis (2,772 vs 94, ROR 9.6 [7.9-11.9]; IC025 2.85), polymyalgia rheumatica (1,504 vs 76, ROR 14.6 [11.6-18.4]; IC025 3.34), Sjogren’s syndrome (2,000 vs 49, ROR 6.9 [5.2-9.2]; IC025 2.24) and scleroderma (2,385 vs 17, ROR 2.0 [1.2-3.2]; IC025 0.17). Myositis patients were more frequently male (70.4%; p< 0.0001 vs 56% in other rheumatological irAE patients) and treated with anti-PD1/L1 (ROR 2.8 [1.9-4.0] vs anti-CTLA4) or with ICIs combination (ROR 2.0 [1.6-2.6] vs monotherapy). Myositis occurred earlier compared to other rheumatic irAEs (time to onset: 31 IQR [19.5-58.5] days) and were associated with the highest mortality rate (30.3%, p< 0.0001). Arthritis and Sjogren’s syndrome had similar time to onset (78.5 [25-166.5] and 88 [47.8-145.8] days, respectively), and were associated with a mortality of 6.9 and 0%. Arthritis and Sjogren’s syndrome occurred more frequently in patients with anti-PD1/L1 (vs anti-CTLA4; ROR 2.1 [1.6-2.8] or 4.4 [1.0-18.1]) with ICI combination (vs monotherapy; ROR 1.6 [1.3-2.0] and 2.9 [1.5-5.6]) whereas polymyalgia rheumatica was more frequently reported in patients with anti-PD1/L1 monotherapy (ROR 5.6 [1.8-17.7]). Sarcoidosis occurred in younger patients (57 [48-65.3] years) and with a longer time to onset (174 [71.5-275.8] days; p< 0.001). Scleroderma had the longest time to onset (395.5 [323.8-457.2] days; p< 0.001).

Conclusion: Among rheumatic disorders in addition to vasculitis: arthritis, myositis, sarcoidosis, polymyalgia rheumatica, Sjogren’s syndrome and scleroderma have a higher reporting. Patients characteristics, type of ICI, time to onset, and patient outcome depend on the type of rheumatic irAEs. Myositis is the most severe.

Figure 1: Delay between the first immune checkpoint inhibitor infusion and the onset of the rheumatic adverse events


Disclosure: C. Anquetil, None; O. Benveniste, None; J. Moslehi, None; D. Johnson, None; B. lebrun-vignes, None; O. Lambotte, None; J. Selam, None; J. Spano, None; Y. Allenbach, None.

To cite this abstract in AMA style:

Anquetil C, Benveniste O, Moslehi J, Johnson D, lebrun-vignes B, Lambotte O, Selam J, Spano J, Allenbach Y. Rheumatic Toxicities Associated with Immune Checkpoint Inhibitors: An Observational, Retrospective, Pharmacovigilance Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/rheumatic-toxicities-associated-with-immune-checkpoint-inhibitors-an-observational-retrospective-pharmacovigilance-study/. Accessed .
  • Tweet
  • Email
  • Print

« Back to 2019 ACR/ARP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/rheumatic-toxicities-associated-with-immune-checkpoint-inhibitors-an-observational-retrospective-pharmacovigilance-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