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Clinical Trial
. 2025 Jun 1;64(6):3863-3871.
doi: 10.1093/rheumatology/keaf122.

Efficacy and safety of avacopan in patients aged 65 years and older with ANCA-associated vasculitis: a post hoc analysis of data from the ADVOCATE trial

Duvuru Geetha  1 , Christian Pagnoux  2 , Sebastian E Sattui  3 , Peter A Merkel  4   5 , Maria Weiner  6 , Juliana Draibe  7 , Stanislas Faguer  8 , Sarah Bray  9 , Rachel E Gurlin  10 , Monica Balcells-Oliver  11 , Annette Bruchfeld  6   12 , David R Jayne  13 ; ADVOCATE Study Group
Collaborators, Affiliations
Clinical Trial

Efficacy and safety of avacopan in patients aged 65 years and older with ANCA-associated vasculitis: a post hoc analysis of data from the ADVOCATE trial

Duvuru Geetha et al. Rheumatology (Oxford). .

Abstract

Objectives: To evaluate the efficacy and safety of avacopan in patients aged ≥65 years with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) in the phase 3 ADVOCATE trial of avacopan vs a prednisone taper, plus either rituximab or cyclophosphamide.

Methods: In this descriptive, post hoc analysis, patients receiving avacopan or a prednisone taper were stratified by age. Key efficacy outcomes included the rate of remission at week 26 and sustained remission at week 52.

Results: Of 160 patients aged ≥65, 109 were aged 65-74 and 51 were ≥75. Remission at week 26 was achieved in 71.7% vs 69.4% of patients aged 65-74 and 73.1% vs 72.0% aged ≥75 in the avacopan vs prednisone taper groups, respectively. Sustained remission at week 52 was observed in 65.0% vs 55.1% of patients aged 65-74 and 65.4% vs 56.0% aged ≥75. Relapse rates in the avacopan vs prednisone taper groups were 12.3% vs 18.8% and 3.8% vs 20.8% in the 65-74 and ≥75 subgroups, respectively. Improvements in estimated glomerular filtration rate and health-related quality of life were observed in both treatment groups. Use of avacopan compared with a prednisone taper was associated with a 61% and 49% reduction in mean glucocorticoid dose in the 65-74 and ≥75 subgroups, respectively, and lower glucocorticoid toxicity. The proportions of patients with adverse events were similar between treatment groups within each age subgroup.

Conclusion: These data support the efficacy and safety of an avacopan-based regimen to treat patients with GPA or MPA aged ≥65.

Keywords: AAV; GPA; MPA; age; avacopan.

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Figures

Figure 1.
Figure 1.
eGFR during a 52-week treatment period in patients with GPA or MPA in the ADVOCATE trial. (A–C) Change in eGFR from baseline in patients aged <65, 65–74 and ≥75 years, respectively. (D) Mean ± s.e.m. eGFR at baseline and week 52 in patients aged <65, 65–74 and ≥75 years. eGFR was assessed only in patients with kidney involvement (based on BVAS) at baseline. eGFR: estimated glomerular filtration rate; LSM: least squares mean; MPA: microscopic polyangiitis
Figure 2.
Figure 2.
Health-related quality of life outcomes of (A) SF-36 physical component summary score, (B) SF-36 mental component summary score, (C) EQ-5D-5L VAS and (D) EQ-5D-5L index score at week 52 in patients with GPA or MPA stratified by age treated with avacopan or a prednisone taper. EQ-5D-5L: EuroQol 5-Dimension 5-Level; GPA: granulomatosis with polyangiitis; LSM: least squares mean; MPA: microscopic polyangiitis; SF-36: Short Form-36; VAS: visual analogue scale
See this image and copyright information in PMC

References

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