Abstract: SA-PO870
Safety and Efficacy of Avacopan in Patients 65 Years and Older with ANCA-Associated Vasculitis
Session Information
- Glomerular Diseases: Therapeutics
November 04, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Trials
Authors
- Geetha, Duvuru, Johns Hopkins University, Baltimore, Maryland, United States
- Pagnoux, Christian, University of Toronto, Toronto, Ontario, Canada
- Sattui, Sebastian E., University of Pittsburgh, Pittsburgh, Pennsylvania, United States
- Merkel, Peter A., University of Pennsylvania, Philadelphia, Pennsylvania, United States
- Jayne, David R.W., University of Cambridge, Cambridge, United Kingdom
Group or Team Name
- ADVOCATE Study Group.
Background
Older adults are at increased risk of glucocorticoid (GC)-related toxicity; minimization of GCs is a major focus for treatment of patients with ANCA-associated vasculitis (AAV). Although AAV especially affects older adults, many studies have excluded patients >75 years (y). In the Phase 3 ADVOCATE trial of avacopan, there was no exclusion criterion for maximum participant age.
Methods
This post hoc analysis reports safety and efficacy of avacopan compared to a prednisone taper in the subgroups of patients 65-74y (N=109) and ≥75y (N=51).
Results
In both studied age and treatment groups, a similar proportion of patients (69.4-73.1%) achieved remission at week 26 (Table 1). In the 65-74y age group, sustained remission rates at week 52 were 55.1% in the prednisone arm and 65.0% in the avacopan arm. Relapse rates were 18.8% in the prednisone arm and 12.3% in the avacopan arm. The total all-source median GC dose was 5.3x higher in the prednisone vs avacopan arm. Serious adverse events (SAEs) occurred in 22/49 patients (45%) in the prednisone arm (2 deaths) and 25/60 patients (42%) in the avacopan arm (2 deaths). In the ≥75y age group, sustained remission rates at week 52 were 56.0% in the prednisone arm and 65.4% in the avacopan arm. Relapse rates were 20.8% in the prednisone arm and 3.8% in the avacopan arm. Median GC dose was 4.8x higher in the prednisone vs avacopan arm. SAEs occurred in 14/25 patients (56%) in the prednisone arm and 17/26 patients (65%) in the avacopan arm. Other results including renal and quality of life outcomes are in Table 1.
Conclusion
A subgroup analysis of patients ≥65y demonstrated similar trends of efficacy and safety of avacopan as in the overall ADVOCATE trial, including reductions in GC-related toxicities, supporting a role for avacopan in the treatment of older patients with AAV.
Funding
- Commercial Support – Amgen