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. 2023 Feb 3;8(4):860-870.
doi: 10.1016/j.ekir.2023.01.039. eCollection 2023 Apr.

Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan

Frank B Cortazar  1 , John L Niles  2 , David R W Jayne  3 , Peter A Merkel  4 , Annette Bruchfeld  5   6 , Huibin Yue  6 , Thomas J Schall  6 , Pirow Bekker  6 ; ADVOCATE Study Group
Collaborators, Affiliations

Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan

Frank B Cortazar et al. Kidney Int Rep. .

Abstract

Introduction: In the 330-patient ADVOCATE trial of avacopan for the treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, in which 81% of patients had renal involvement, estimated glomerular filtration rate (eGFR) increased on average 7.3 ml/min per 1.73 m2 in the avacopan group and 4.1 ml/min per 1.73 m2 in the prednisone group (P = 0.029) at week 52. This new analysis examines the results in the patient subgroup with severe renal insufficiency at enrollment into the trial, i.e., eGFR ≤20 ml/min per 1.73 m2.

Methods: eGFR was determined at baseline and over the course of the trial. Changes in eGFR were compared between the 2 treatment groups.

Results: In ADVOCATE, 27 of 166 patients (16%) in the avacopan group and 23 of 164 patients (14%) in the prednisone group had a baseline eGFR ≤20 ml/min per 1.73 m2. At week 52, eGFR increased on average 16.1 and 7.7 ml/min per 1.73 m2 in the avacopan and prednisone groups, respectively (P = 0.003). The last eGFR value measured during the 52-week treatment period was ≥2-fold higher than baseline in 41% of patients in the avacopan group compared to 13% in the prednisone group (P = 0.030). More patients in the avacopan group versus prednisone group had increases in eGFR above 20, 30, and 45 ml/min per 1.73 m2, respectively. Serious adverse events occurred in 13 of 27 patients (48%) in the avacopan group and 16 of 23 patients (70%) in the prednisone group.

Conclusion: Among patients with baseline eGFR ≤20 ml/min per 1.73 m2 in the ADVOCATE trial, eGFR improved more in the avacopan group than in the prednisone group.

Keywords: ANCA-associated vasculitis; avacopan; complement; complement 5a receptor; low eGFR; renal recovery.

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Figures

None
Graphical abstract
Figure 1
Figure 1
Disposition among patients in the ADVOCATE trial with baseline eGFR ≤20 ml/min per 1.73 m2. Of the 50 patients with baseline eGFR ≤20 ml/min per 1.73 m2, 23 were in the prednisone group and 27 in the avacopan group. Three patients in the prednisone group and 4 in the avacopan group discontinued the study early, most within the first 26 weeks. eGFR, estimated glomerular filtration rate.
Figure 2
Figure 2
Change in kidney function among patients in the ADVOCATE trial with baseline eGFR ≤20 ml/min per 1.73 m2. Least squares mean (± SEM) change from baseline in eGFR by treatment group over the 52-week treatment period. ∗P < 0.05, ∗∗P < 0.01 for comparison of the avacopan group to prednisone group by mixed effects model for repeated measures analysis with treatment group, study visit, and treatment-by-visit interaction as factors, and baseline as covariate. eGFR, estimated glomerular filtration rate.
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