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: 1076

ANCA-Associated Vasculitis Treated with Avacopan versus a Standard Prednisone Taper: Glucocorticoid Toxicity Index Scores by Domain

Naomi Patel1, David Jayne2, Peter Merkel3, Pirow Bekker4, yuqing zhang5, Huibin Yue4 and John Stone6, 1Massachusetts General Hospital, Sale Creek, TN, 2University of Cambridge, Cambridge, United Kingdom, 3University of Pennsylvania, Philadelphia, PA, 4ChemoCentryx, San Juan Capistrano, CA, 5Massachusetts General Hospital, Quincy, MA, 6Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston, MA

Meeting: ACR Convergence 2022

Keywords: ANCA associated vasculitis, Drug toxicity, glucocorticoids, Vasculitis

  • Tweet
  • Email
  • Print
Session Information

Date: Sunday, November 13, 2022

Title: Vasculitis – ANCA-Associated Poster II: Treatment Efficacy, Clinical Outcomes, Biomarkers

Session Type: Poster Session B

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

Background/Purpose: The ADVOCATE trial (Jayne DRW et al, N Engl J Med, 2021) was a randomized, double-blind, controlled trial of avacopan vs prednisone in addition to standard care in ANCA-associated vasculitis (AAV). The Glucocorticoid Toxicity Index (GTI), a composite score, measures change in GC toxicity. Data from the GTI domains provide a Cumulative Worsening Score (CWS) and an Aggregate Improvement Score (AIS), allowing investigators to track not only worsening in GC toxicity but also improvement (or aggregate change) across the full GTI and within individual domains.

In ADVOCATE, the avacopan group achieved lower overall CWS & AIS values than the prednisone group, representing less GC toxicity. At week 26, the mean CWS and AIS scores were significantly lower in the avacopan than prednisone groups, and the differences exceeded the minimum clinically important difference of the GTI. Individual GTI domain scores, however, have not been analyzed. This analysis evaluates scores from the 8 GTI domains in ADVOCATE: Body Mass Index, Glucose Tolerance, Lipid Metabolism, Blood Pressure, GC Myopathy, Skin, Neuropsychiatric, and Infection.

Methods: The CWS tabulates the cumulative total of GC-related toxicities occurring between two time points. The AIS measures aggregate change – worsening as well as improvement – adding toxicities that occur/worsen but reducing or removing those that improve/resolve. We used Mantel-Haenszel Chi-Square tests to evaluate differences between the avacopan and prednisone groups’ GTI domain sub-scores at weeks 13 and 26. Week 26 scores were the sum of scores from baseline to week 13 and from week 13 to week 26.

Results: All patients in ADVOCATE were included in the analysis. Of the 330 patients, 321 had complete data at week 13; 307 had complete data at week 26. The total mean (median) GC use during the first 26 weeks was 1,073 mg (400 mg) in the avacopan group, and 3,193 mg (2,847 mg) in the prednisone group. Multiple domains favored the avacopan group in GC toxicity reduction (Table 1). For the CWS at week 26, the distribution of scores in the Body Mass Index (P=0.02), Lipid Metabolism (P< 0.01), and Skin (P=0.02) domains all significantly favored the avacopan group. These domains also differentiated the two groups at 13 weeks. GC Myopathy and Infection showed favorable trends at 26 weeks (P=0.06 and P=0.07, respectively). Glucose Tolerance domain CWS values, were lower in the avacopan group at both 13 and 26 weeks and were statistically significant at 13 weeks (P< 0.01). For the AIS domains, Body Mass Index, Lipid Metabolism, and Skin were all lower in the avacopan group at both 13 and 26 weeks. Statistical comparisons for all domains are shown in Table 1.

Conclusion: This study confirms the substantial reduction in GC toxicity associated with replacing a standard prednisone tapering schedule with avacopan in the treatment of AAV. Moreover, these data demonstrate that the benefits were experienced across multiple domains of toxicity, emphasizing the value of a composite measure that quantifies GC toxicity directly, assessing both cumulative toxicity and aggregate change.

Supporting image 1

Table 1. Glucocorticoid Toxicity Index (GTI) Cumulative Worsening Scores (CWS) and Aggregate Improvement Scores (AIS) for individual domains at weeks 13 and 26 by treatment group in the ADVOCATE study.


Disclosures: N. Patel, FVC Health; D. Jayne, Aurinia, AstraZeneca, GlaxoSmithKline (GSK), Roche/Genentech, Vifor, Bristol-Myers Squibb(BMS), Chemocentryx, Novartis, Takeda, Boehringer-Ingelheim, Otsuka, UCB, Amgen, Kessai; P. Merkel, AbbVie, AstraZeneca, Boeringher-Ingelheim, Bristol-Myers Squibb, ChemoCentryx, Forbius, Genentech/Roche, Genzyme/Sanofi, GlaxoSmithKline, InflaRx, Neutrolis, Takeda, CSL Behring, Dynacure, EMDSerono, Immagene, Jannsen, Kiniksa, Magenta, Novartis, Pfizer, Q32, Regeneron, Sparrow, Eicos, Electra, Kyverna, UpToDate; P. Bekker, Chemocentryx; y. zhang, None; H. Yue, Chemocentryx; J. Stone, Horizon Theraputics, Sanofi, Amgen, Argenx, Bristol-Myers Squibb(BMS), Chemocentryx, Kyverna, Novartis, Palleon Pharmaceuticals, PPD, Q32, Star Therapeutics, Roche, Mirabio, Spruce Biosciences, Steritas, Zenas.

To cite this abstract in AMA style:

Patel N, Jayne D, Merkel P, Bekker P, zhang y, Yue H, Stone J. ANCA-Associated Vasculitis Treated with Avacopan versus a Standard Prednisone Taper: Glucocorticoid Toxicity Index Scores by Domain [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/anca-associated-vasculitis-treated-with-avacopan-versus-a-standard-prednisone-taper-glucocorticoid-toxicity-index-scores-by-domain/. Accessed .
  • Tweet
  • Email
  • Print

« Back to ACR Convergence 2022

ACR Meeting Abstracts - https://acrabstracts.org/abstract/anca-associated-vasculitis-treated-with-avacopan-versus-a-standard-prednisone-taper-glucocorticoid-toxicity-index-scores-by-domain/

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