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. 2024 Mar 26;9(6):1783-1791.
doi: 10.1016/j.ekir.2024.03.022. eCollection 2024 Jun.

Real-World Experience With Avacopan in Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis

Reza Zonozi  1   2 , Faten Aqeel  3 , Dustin Le  3 , Frank B Cortazar  4 , Jugal Thaker  5 , Maria Jose Zabala Ramirez  6 , Sebastian Eduardo Sattui Cortes  7 , Rose Mary Attieh  8 , Madeline Chung  9 , David H Bulbin  10 , Aisha Shaikh  11 , Karina Guaman  12 , Julia Ford  13 , Colin Diffie  11 , Ora Gewurz-Singer  13 , Gabriel Sauvage  14 , Anushya Jeyabalan  14 , Abdallah Geara  5 , Isabelle Ayoub  9 , Andrew Bomback  12 , Lara L Khoury  8   15 , Jason C George  10 , Kenar D Jhaveri  8 , Vimal Kumar Derebail  6 , John L Niles  14 , Duvuru Geetha  3
Affiliations

Real-World Experience With Avacopan in Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis

Reza Zonozi et al. Kidney Int Rep. .

Abstract

Introduction: Postmarketing data on outcomes of avacopan use in antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) are lacking.

Methods: We performed a multicenter retrospective analysis of 92 patients with newly diagnosed or relapsing AAV who received therapy with avacopan. The coprimary outcome measures were clinical remission at 26 and 52 weeks. We use descriptive statistics and univariate logistic regression to assess outcomes and predictors of remission, respectively.

Results: Of the 92 patients, 23% (n = 21) had a baseline estimated glomerular filtration rate (eGFR) < 15 ml/min per 1.73 m2 and 10% on kidney replacement therapy at baseline. Among those with kidney involvement, mean (SD) enrollment eGFR was 33 (27) ml/min per 1.73 m2 with a mean (SD) change of +12 (25) and +20 (23) ml/min per 1.73 m2 at weeks 26 and 52, respectively. In addition to avacopan, 47% of patients received combination therapy of rituximab and low-dose cyclophosphamide, and 14% of patients received plasma exchange (PLEX). After induction, the median (interquartile range [IQR]) time to start avacopan was 3.6 (2.1-7.7) weeks, and the median time to discontinue prednisone after starting avacopan was 5.6 (3.3-9.5) weeks. Clinical remission was achieved in 90% of patients at week 26 and 84% of patients at week 52. Of the patients, 20% stopped avacopan due to adverse events, with the most common being elevated serum aminotransferases (4.3%).

Conclusion: A high rate of remission and an acceptable safety profile were observed with the use of avacopan in the treatment of AAV in this postmarketing analysis, including the populations excluded from the ADVOCATE trial.

Keywords: ANCA-associated vasculitis; avacopan; complement; kidney recovery; remission.

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Figures

None
Graphical abstract
Figure 1
Figure 1
eGFR during follow-up among patients with kidney involvement (n = 71 at week 0 which decreased to n = 22 by week 52). We plot the boxplot at each time point and the mean eGFR (dark black line). Black dots represent data points >1.5× the interquartile range of each respective follow-up. Individuals on dialysis were given an eGFR of 5 ml/min per 1.73m2. eGFR, estimated glomerular filtration rate.
Figure 2
Figure 2
eGFR stratified by timing of avacopan initiation among those with kidney involvement and 52 weeks of follow-up (n = 22). We plot the difference in mean eGFR between those who started avacopan within and after 30 days of induction date. eGFR, estimated glomerular filtration rate.
Figure 3
Figure 3
Kaplan-Meier curve of PO steroid discontinuation among those on PO steroids stratified by timing of avacopan initiation. PO, by mouth.
See this image and copyright information in PMC

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