Abstract: SA-PO734
General, Nervous System, Eye, and Skin Involvement in the Phase 3 Trial of Avacopan for the Treatment of 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
- Geetha, Duvuru, Johns Hopkins University, Baltimore, Maryland, United States
- Hajj-Ali, Rula, Cleveland Clinic, Cleveland, Ohio, United States
- Luqmani, Raashid Ahmed, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom
- Pagnoux, Christian, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada
- Trimpe, Darcy, Amgen Inc, Thousand Oaks, California, United States
- Jayne, David R.W., University of Cambridge, Cambridge, Cambridgeshire, United Kingdom
- Merkel, Peter A., University of Pennsylvania, Philadelphia, Pennsylvania, United States
Group or Team Name
- ADVOCATE Study Group.
Background
The most common types of ANCA-associated vasculitis, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), can affect many organs. The phase 3 ADVOCATE trial compared avacopan vs a prednisone taper to treat patients with GPA or MPA. Patients receiving avacopan had improvements in sustained remission and kidney outcomes, with less glucocorticoid (GC) exposure and GC-related toxicity than those receiving a prednisone taper.
Methods
This post hoc analysis of the ADVOCATE trial reports rates of active general, nervous system, mucous membranes/eyes, and skin involvement based on the Birmingham Vasculitis Activity Score (BVAS) at weeks 4, 26, and 52, and changes from baseline to week 52.
Results
In the 330-patient ADVOCATE trial, active involvement of the general, nervous system, mucous membranes/eyes, and skin domains affected 68.2% (n=225), 20.9% (n=69), 20.0% (n=66), and 14.2% (n=47) of patients, respectively; most patients had at least one of these manifestations (Table). Similar and substantial improvements in the control of active disease in these domains were achieved in both groups: reductions from baseline to week 52 in the proportion of patients with active manifestations in the avacopan vs prednisone taper group, respectively, were 97.3% vs 96.5% (general), 100% vs 93.5% (nervous system), 100% vs 95.0% (mucous membranes/eyes), and 83.3% vs 100% (skin).
Conclusion
In the ADVOCATE trial, treatment with either avacopan or a prednisone taper was associated with the reversal of nearly all active general, nervous system, mucous membranes/eyes, and skin manifestations of GPA or MPA.
Funding
- Commercial Support – Amgen