Session Type: Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: 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 adults with AAV.
To cite this abstract in AMA style:Jayne D, Geetha D, Pagnoux C, Sattui S, Merkel P. Safety and Efficacy of Avacopan in Patients 65 Years and Older with ANCA-Associated Vasculitis [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/safety-and-efficacy-of-avacopan-in-patients-65-years-and-older-with-anca-associated-vasculitis/. Accessed .
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-efficacy-of-avacopan-in-patients-65-years-and-older-with-anca-associated-vasculitis/