Safety and Efficacy of Avacopan in Patients 65 Years and Older with ANCA-Associated Vasculitis

David Jayne¹, Duvuru Geetha², Christian Pagnoux³, Sebastian Sattui⁴ and Peter Merkel⁵, ¹University of Cambridge, Cambridge, United Kingdom, ²Johns Hopkins University, Baltimore, MD, ³Mount Sinai Hospital, Toronto, ON, Canada, ⁴University of Pittsburgh, Pittsburgh, PA, ⁵University of Pennsylvania, Philadelphia, PA

Meeting: ACR Convergence 2023

Keywords: ANCA associated vasculitis, complement, geriatrics, Granulomatosis with Polyangiitis (GPA), Microscopic Polyangiitis

Session Information

Date: Sunday, November 12, 2023

Title: (0673–0690) Vasculitis – ANCA-Associated Poster I: Treatment Outcomes

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.

Disclosures: D. Jayne: AstraZeneca, 2, Aurinia, 4, Boehringer Ingelheim, 2, Chinook, 2, CSL Vifor, 2, Roche, 2; D. Geetha: Amgen, 2, Aurinia, 2, calliditas, 2, chemocentryx, 2, GlaxoSmithKlein(GSK), 2; C. Pagnoux: AstraZeneca, 1, 2, 6, GlaxoSmithKlein(GSK), 1, 6, Otsuka, 1, 2, 5, 6, Pfizer, 5, Roche, 2; S. Sattui: AstraZeneca, 5, Bristol Myers Squibb Foundation, 5, Rheumatology Research Foundation, 5, Sanofi, 2, 5; P. Merkel: AbbVie/Abbott, 5, Amgen, 2, 5, ArGenx, 2, AstraZeneca, 2, 5, Boehringer-Ingelheim, 2, 5, Bristol-Myers Squibb(BMS), 2, 5, Cabaletta, 2, CSL Behring, 2, Eicos, 5, Electra, 5, Genentech, 5, GlaxoSmithKlein(GSK), 2, 5, HiBio, 2, InflaRx, 2, 5, Janssen, 2, Jubilant, 2, Kyverna, 2, 11, MiroBio, 2, Neutrolis, 5, Novartis, 2, NS Pharma, 2, Q32, 2, Regeneron, 2, Sanofi, 2, Sparrow, 2, Takeda, 2, 5, UpToDate, 9, Visterra, 2.

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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