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: 0763

Immunogenicity Analysis from the VOLTAIRE Trials in Patients with Rheumatoid Arthritis, Crohn’s Disease, and Chronic Plaque Psoriasis

Vibeke Strand1, Shaun Bender2 and Dorothy McCabe3, 1Stanford University School of Medicine, Stanford, CA, 2Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, 3Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT

Meeting: ACR Convergence 2022

Keywords: Anti-TNF Drugs, Biologicals, clinical trial, Randomized Trial, rheumatoid 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: Sunday, November 13, 2022

Title: Immunological Complications of Medical Therapy Poster

Session Type: Poster Session B

Session Time: 9:00AM-10:30AM

Background/Purpose: The VOLTAIRE trials program compared the safety, efficacy, and immunogenicity of biosimilar BI 695501 with adalimumab reference product (RP) for indications including moderate-severely active rheumatoid arthritis (RA), Crohn’s disease (CD), and chronic plaque psoriasis (PsO).1,2,3 These analyses compare immunogenicity across these indications and by patient sex.

Methods: Details of each active-comparator, randomized controlled trial (RCT) are presented in Table 1. Immunogenicity was assessed at various timepoints by the proportion of patients with anti-drug antibodies (ADAs) and neutralizing antibodies (nAbs), using acid dissociation followed by an electrochemiluminescence assay (ECL; MSD platform; Meso Scale Diagnostics LLC, USA).4 Assay sensitivity was 50 ng/mL, and drug tolerance ≥30 μg/mL (free drug) at the low positive control level.

Results: Data are presented in Table 2.

Conclusion: These data demonstrate minor differences in immunogenicity parameters (ADAs, ADA titers and nAbs) between BI 695501 and adalimumab RP across these 3 immune-mediated inflammatory diseases (IMIDs). The proportion of ADA- and nAb-positive patients increased from baseline over time in all 3 RCTs, as expected, and were similar in the RA and CD RCTs. However, higher rates of ADA- and nAb-positive patients were reported in the PsO trial. Subgroup analysis by patient sex showed the same trend. Differences among the RCTs may be partially explained by concomitant background therapy (MTX) in the RA trial, stable doses of AZA, 6-MP or MTX in 36% of CD patients and the absence of background therapy in the PsO RCT. In addition, comparisons are limited by the different visit schedules among the trials. Historical comparisons to data for the RP are complicated by recent differences in regulatory requirements for increased ADA assay sensitivity and stringency for biosimilar products than those originally used for the RP. Acid dissociation followed by the more sensitive ECL assay for detection of ADAs is not dependent on serum drug concentrations. In conclusion, these analyses confirm the biosimilarity of BI 695501 with the adalimumab RP across IMIDs.

Supporting image 1

Table 1

Supporting image 2

Table 2


Disclosures: V. Strand, AbbVie, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb(BMS), Boehringer-Ingelheim, Chemocentryx, Celltrion, Genentech/Roche, Gilead, GlaxoSmithKlein(GSK), Inmedix, Janssen, Kiniksa, Merck/MSD, Novartis, Pfizer, Regeneron Pharmaceuticals, Rheos, R-Pharma, Samsung, Sandoz, Sanofi, Scipher, Setpoint, Spherix, Aria, Bioventus, Blackrock, Equilium, Glenmark, Horizon, Kypha, Lilly, MiMedx, Sorrento, Tonix, Priovant; S. Bender, Boehringer-Ingelheim; D. McCabe, Boehringer-Ingelheim.

To cite this abstract in AMA style:

Strand V, Bender S, McCabe D. Immunogenicity Analysis from the VOLTAIRE Trials in Patients with Rheumatoid Arthritis, Crohn’s Disease, and Chronic Plaque Psoriasis [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/immunogenicity-analysis-from-the-voltaire-trials-in-patients-with-rheumatoid-arthritis-crohns-disease-and-chronic-plaque-psoriasis/. 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/immunogenicity-analysis-from-the-voltaire-trials-in-patients-with-rheumatoid-arthritis-crohns-disease-and-chronic-plaque-psoriasis/

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