REAL-WORLD USE AND EXTENDED TREATMENT OUTCOMES OF AVACOPAN IN ANCA-ASSOCIATED VASCULITIS: INSIGHTS FROM THE MULTICENTER EUROPEAN AVAC-EUR STUDY

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Abstract Title *

REAL-WORLD USE AND EXTENDED TREATMENT OUTCOMES OF AVACOPAN IN ANCA-ASSOCIATED VASCULITIS: INSIGHTS FROM THE MULTICENTER EUROPEAN AVAC-EUR STUDY

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Co-author 1

Koen de Koning k.f.de_koning@lumc.nl Leiden University Medical Center Center of Expertise for Lupus-, Vasculitis- and Complement-mediated Systemic diseases (LuVaCs), Department of Internal Medicine - Nephrology section Leiden Netherlands -

Co-author 2

Jolijn van Leeuwen j.r.van_leeuwen@lumc.nl Leiden University Medical Center Center of Expertise for Lupus-, Vasculitis- and Complement-mediated Systemic diseases (LuVaCs), Department of Internal Medicine - Nephrology section Leiden Netherlands -

Co-author 3

Enriqe Morales emoralesr@senefro.org Hospital Universitario 12 de Octubre Department of Nephrology Madrid Spain -

Co-author 4

Arne Lindholm arne.lindholm@regionstockholm.se Karolinska Institutet Division of Rheumatology Stockholm Sweden -

Co-author 5

Iva Gunnarson iva.gunnarsson@regionstockholm.se Karolinska Institutet Division of Rheumatology Stockholm Sweden -

Co-author 6

Ben Sprangers ben.sprangers@zol.be Ziekenhuis Oost-Limburg Department of Nephrology Genk Belgium -

Co-author 7

Elena Treppo treppo.elena@gmail.com University of Udine Division of Rheumatology Udine Italy -

Co-author 8

Luca Quartuccio luca.quartuccio@uniud.it University of Udine Division of Rheumatology Udine Italy -

Co-author 9

Onno Teng y.k.o.teng@lumc.nl Leiden University Medical Center Center of Expertise for Lupus-, Vasculitis- and Complement-mediated Systemic diseases (LuVaCs), Department of Internal Medicine - Nephrology section Leiden Netherlands *

Co-author 10

Co-author 11

Co-author 12

Co-author 13

Co-author 14

Co-author 15

Introduction

Avacopan was approved in Europe in 2022 for the treatment of active and severe ANCA-associated vasculitis (AAV). Clinical study data are limited to 1 year with no structured data on extended (EXT) avacopan treatment. Between 2020-2025, an early access program (EAP) enabled avacopan use until its commercial availability. The AVAC-EUR study is designed to study the real-world clinical practice of early access avacopan, to improve our understanding of avacopan-based treatment strategies in AAV, including the use of avacopan beyond 1 year.

Methods

AVAC-EUR is a multicenter, European retrospective observational study that included AAV patients treated with avacopan since EAP was initiated. A descriptive analysis of demographics, disease and treatment characteristics was performed, along with a comparative analysis on clinical outcomes, including relapses, hospitalizations and infections, amongst AAV patients receiving avacopan ≤1 year and EXT-avacopan (i.e. >1 year), all with a follow-up of ≥1.5 years.

Results

AVAC-EUR included 108 patients (Italy 42.6%, Netherlands 32.4%, Spain 14.8%, Sweden 7.4%, Belgium 2.8%) with a median [IQR] age 61 [51–73] years, 48.1% females and disease duration of 8.8 [1.7–66.0] months. Avacopan-based treatment strategies included predominantly rituximab (84.3%), and cyclophosphamide (20.4%). Avacopan was started around induction regimen with high-dose in 69.4% and 21.2% with low-dose corticosteroids; 5.6% received no steroids.
Examining 38 (71.7%) AAV patients with EXT-avacopan versus 15 (28.3%) with ≤1 year avacopan, all patients achieved remission (i.e. BVAS 0 at 6 months) and throughout the follow-up course cumulative steroid dose and rituximab maintenance were similar. Within the first year, infections and hospitalizations were more frequent in avacopan ≤1 year. EXT-avacopan did not increase infections or hospitalizations and showed fewer relapses (0.13 vs 0.35 per patient-year, p=0.08).

Conclusion

In European real-world practice, avacopan during EAP was predominantly combined with rituximab and steroids. Extended treatment beyond 1 year may lower relapse risk without increased infections or hospitalizations.

The content presented in this abstract was also submitted for the 22nd International Vasculitis Workshop 2026 in Melbourne, Australia.

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