Kidney Week

Abstract: FR-PO0631

Avacopan Real-World Safety in Adults with ANCA-Associated Vasculitis: AvacoStar Interim Results

Session Information

• Glomerular Diseases: Clinical, Outcomes, and Therapeutics Research - ANCA/FSGS
  October 23, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

• Jayne, David R.W., University of Cambridge, Cambridge, United Kingdom

David R.W. Jayne, MD, MBChB

• Luqmani, Raashid Ahmed, University of Oxford, Oxford, United Kingdom

Raashid Ahmed Luqmani, MD, MBBS

• Terrier, Benjamin, Hopital Cochin, Paris, France

Benjamin Terrier

• Balcells-Oliver, Monica, CSL Vifor, Glattbrugg, Switzerland

Monica Balcells-Oliver

• Obergfell, Achim, CSL Vifor, Glattbrugg, Switzerland

Achim Obergfell, MD, PhD, MBA

• Boff, Marie Elise, CSL Vifor, Glattbrugg, Switzerland

Marie Elise Boff, MS, MSc

• Baquero, Elbalejandra, CSL Vifor, Glattbrugg, Switzerland

Elbalejandra Baquero, MSc, MPH

• Hellmich, Bernhard, Medius Kliniken, University of Tubingen, Kirchheim unter Teck, Germany

Bernhard Hellmich, MD

Group or Team Name

• The AvacoStar Study Group

Background

Avacopan long-term safety data remain limited. The AvacoStar post-authorization safety study (PASS) was initiated to increase our understanding of avacopan’s real-world safety profile. Here we present interim results focusing on medical events of special interest (MESIs), including liver injury, cardiac safety, serious infections, and malignancy.

Methods

AvacoStar includes adults with severe active GPA/MPA from the UK and Germany receiving avacopan plus standard-of-care (SoC) (typically RTX and/or CYC) (avacopan group) or SoC without avacopan (non-avacopan group). Primary endpoint: MESIs in the avacopan group. Secondary endpoints include AEs, SAEs, laboratory abnormalities, and patterns of avacopan use. SAE and MESI incidence rates per patient-year (PPY) are compared between groups.

Results

244/254 patients (96.1%) in the avacopan group and 230/250 (92.0%) in the non-avacopan group remained in the study at data cut (Sept 11, 2025). Mean (SD) time in the study since treatment start was 16.2 (4.6) and 12.7 (7.8) months, respectively. Baseline characteristics were mostly similar between groups with some imbalances; avacopan patients were more likely to have kidney involvement (84.6% vs 74.7%), lower eGFR (mean [SD] 37.5 [27.8] vs 42.7 [30.1] mL/min/1.73m²) and receive more intensive induction therapies.

In the avacopan group, 101 MESIs were reported in 72 patients over 341.95 patient-years of follow-up, including 22 liver injuries (21 patients), 43 serious infections (30), 29 cardiac safety events (25) and 7 malignancies (7).

Incidence rates PPY for serious infections, cardiac safety events and malignancies were similar between groups (Table). Although a higher incidence of liver injury was observed in the avacopan vs the non-avacopan group, events were infrequent and increases in liver enzymes were mild to moderate, with one case of increased alanine aminotransferase assessed as serious.

Conclusion

Adults with severe active GPA/MPA (especially those with kidney involvement) are treated with avacopan plus SoC in clinical practice without unexpected safety concerns.

Acknowledgment

Medical writing support for this abstract was provided by Jackie Read from Bright Red Fox Creative Ltd. and was funded by Vifor Fresenius Medical Care Renal Pharma Ltd. The AvacoStar study is funded by Vifor Fresenius Medical Care Renal Pharma Ltd.

Funding

• Commercial Support – Vifor Fresenius Medical Care Renal Pharma Ltd.