Abstract: SA-PO736
Baseline Characteristics of the First Patients in AvacoStar, a Real-World Study of Avacopan in ANCA-Associated Vasculitis
Session Information
- ANCA-Associated Vasculitis, Anti-GBM Disease, and Other RPGN
October 26, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Obergfell, Achim, CSL Vifor, Glattbrugg, Switzerland
- Jayne, David R.W., University of Cambridge, Cambridge, United Kingdom
- Luqmani, Raashid Ahmed, University of Oxford, Oxford, United Kingdom
- Terrier, Benjamin, Hôpital Cochin (Hôpitaux Universitaires Paris Centre), Paris, France
- Flint, Shaun, CSL Vifor, Glattbrugg, Switzerland
- Boff, Marie Elise, CSL Vifor, Glattbrugg, Switzerland
- Balcells-Oliver, Monica, CSL Vifor, Glattbrugg, Switzerland
- Hellmich, Bernhard, Medius Kliniken, University of Tübingen, Kirchheim unter Teck, Germany
Background
Avacopan, an oral, selective C5a receptor antagonist, was approved by the EMA in January 2022 for the treatment of adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), in combination with rituximab or cyclophosphamide. The safety of avacopan is now studied in a real-world cohort followed beyond 1 year.
Methods
AvacoStar (NCT05897684) is a non-interventional, multinational, prospective, post-authorization safety study (≤6 months of data may be collected retrospectively). It will enroll 500 patients in Germany and the UK, in two cohorts of 250: (1) avacopan treated, and (2) receiving a cyclophosphamide- or rituximab-based induction regimen without avacopan. Patients aged ≥18 years with severe, active GPA or MPA in the opinion of the investigator, at the time of commencing avacopan or non-avacopan standard of care induction therapy are eligible. The primary objective is the incidence of defined medical events of special interest (MESI) in the avacopan cohort. MESIs are liver injury, cardiac safety, serious infections, and malignancy. Patients will be followed for up to 7 years. We present the baseline characteristics of the first patients enrolled.
Results
Between Sep 2023 and Mar 2024, 122 patients were enrolled and 118 included in this analysis (n=60 avacopan cohort; n=58 non-avacopan cohort). To date, most patients enrolled are newly diagnosed with renal involvement (Table). Other baseline characteristics are also tabulated.
Conclusion
AvacoStar baseline characteristics are currently similar between groups and consistent with clinical practice, suggesting study outcomes may yield generalizable insights on safety and use patterns of avacopan.
Funding
- Commercial Support – Vifor Fresenius Medical Care Renal Pharma AG