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.
| Original language | English |
|---|---|
| Journal | Kidney International Reports |
| Volume | 8 |
| Issue number | 4 |
| Pages (from-to) | 860-870 |
| Number of pages | 11 |
| ISSN | 2468-0249 |
| DOIs | |
| Publication status | Published - 04.2023 |
Funding
The authors thank all the many study coordinators, investigators, and patients involved for their valuable contributions. The Clinical Trials identifier for this study is NCT02994927. This study was funded by ChemoCentryx, Inc ., San Carlos , CA, USA. The authors thank all the many study coordinators, investigators, and patients involved for their valuable contributions. The Clinical Trials identifier for this study is NCT02994927. This study was funded by ChemoCentryx, Inc. San Carlos, CA, USA. Because of the nature of this research, participants of this study did not agree for their data to be shared publicly, so supporting data are not available. FBC received consulting fees from ChemoCentryx, Aurinia Pharmaceuticals, Travere Therapeutics and ValenzaBio. JLN received consulting and investigator fees from ChemoCentryx and investigator fees from Alexion. DRWJ received consulting and investigator fees from ChemoCentryx, and research grants and consulting fees from Roche/Genentech, a grant from Sanofi/Genzyme, and investigator and consulting fees from Boehringer-Ingelheim and Medimmune, he is supported by the NIHR Cambridge Biomedical Research Centre. PAM reports receiving funds for the following activities in the past 2 years: Consulting: AbbVie, AstraZeneca, Boehringher-Ingelheim, Bristol-Myers Squibb, ChemoCentryx, CSL Behring, Dynacure, EMDSerono, Forbius, Genentech/Roche, GlaxoSmithKline, Immagene, InflaRx, Jannsen, Kiniksa, Kyverna, Magenta, MiroBio, Mitsubishi, Neutrolis, Novartis, NS Pharma, Pfizer, Q32, Regeneron, Sparrow, Takeda. Research Support: AbbVie, AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, ChemoCentryx, Eicos, Electra, Forbius, Genentech/Roche, GlaxoSmithKline, InflaRx, Sanofi, Takeda. Stock options: Kyverna. Royalties: UpToDate. AB received consulting and investigator fees from AstraZeneca, Bayer, ChemoCentryx, Fresenius, Merck/MSD, and Vifor. HY and TJS are employees, and shareholders of ChemoCentryx, the sponsor of this study. PB is a consultant and shareholder of ChemoCentryx.
Research Areas and Centers
- Academic Focus: Center for Infection and Inflammation Research (ZIEL)
DFG Research Classification Scheme
- 2.22-18 Rheumatology
