Kidney Week

Abstract: FR-PO0653

Real-World Effectiveness and Safety of Avacopan in Patients with ANCA-Associated Vasculitis: A Systematic Review and Meta-Analysis

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

• Ibiloye, Elizabeth A., Amgen Inc, Thousand Oaks, California, United States

Elizabeth A. Ibiloye, PhD

• Kathe, Niranjan, Amgen Inc, Thousand Oaks, California, United States

Niranjan Kathe, PhD

• Mirkovic, Kelsey, Amgen Inc, Thousand Oaks, California, United States

Kelsey Mirkovic, PhD

• Martin, Coby, Axtria Inc, Toronto, Ontario, Canada

Coby Martin, MSc

• Gamburg, Rachel, Axtria Inc, Waltham, Massachusetts, United States

Rachel Gamburg

• Kumar, Jatinder, Axtria India Pvt Ltd, Gurugram, Haryana, India

Jatinder Kumar, MS

• Solanki, Goutam Singh, Axtria India Pvt Ltd, Gurugram, Haryana, India

Goutam Singh Solanki

• Tu, Siyu, Axtria Inc, Berkeley Heights, New Jersey, United States

Siyu Tu, MS

• Wallace, Zachary, Amgen Inc, Thousand Oaks, California, United States

Zachary Wallace, MD, MS, MSc

Background

Avacopan is a treatment option for severe active ANCA-associated vasculitis (AAV), but a comprehensive assessment of real-world treatment outcomes is lacking. We conducted a systematic literature review and meta-analysis to evaluate the real-world effectiveness and safety of avacopan.

Methods

MEDLINE, Embase, Cochrane CENTRAL, and conference proceedings were searched for non-interventional studies of real-world avacopan use in adults with AAV, which reported on outcomes of interest (Oct 2021 to Feb 28, 2026). Outcomes assessed included remission, sustained remission, relapses, glucocorticoid (GC) use, hepatotoxicity (serious: per author report or hospitalization), and exploratory kidney outcomes. Risk of bias was assessed using design-appropriate tools, and random-effects meta-analyses were performed where feasible.

Results

Forty-eight reports, including 20 from Japan, contributed to at least 1 endpoint (Figure 1). Pooled 12-month remission was 93% (95% CI, 86-97%; 12 studies), sustained remission was 86% (74-93%; 8 studies), and relapse was 7% (4-11%; 12 studies). GC use was 36% at 6 months (21-54%; 10 studies) and 36% at 12 months (22-53%; 7 studies). Exploratory kidney outcomes showed 66% dialysis liberation (34-88%; 4 studies) and mean eGFR improvement of 17.68 mL/min/1.73 m² (12.65-22.70; 4 studies). Hepatotoxicity incidence was 11% (7-15%; 32 studies) overall and 21% in Japan (16-27%; 15 studies); serious hepatotoxicity was 7% (3-18%; 10 studies) overall and 11% (5-21%; 5 studies) in Japan.

Conclusion

In heterogeneous real-world AAV populations, avacopan was associated with high rates of remission and sustained remission, low relapse, low GC use, and improved kidney outcomes. Hepatic safety findings warrant contextual interpretation, including regional variability.

Figure 1. Pooled outcomes for avacopan overall and Japan subgroup, where available

Funding

• Commercial Support – Amgen Inc