Avacopan bests prednisone for kidney function recovery in ANCA vasculitis
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Avacopan yielded significantly better kidney function outcomes than prednisone in a cohort of patients with renal disease associated with anti-neutrophil cytoplasmic antibody vasculitis, according to data presented at ACR Convergence 2021.
“This poster describes the effect of avacopan [Tavneos, ChemoCentryx], a selective complement C5a receptor inhibitor, on kidney function in patients with ANCA-associated vasculitis,” David Jayne, MD, of the University of Cambridge, in England, said in his presentation. “It draws from the results of a phase 3 trial called ADVOCATE.”
ADVOCATE was a randomized, double-blind, controlled trial that included 330 patients overall. Jayne and colleagues previously presented efficacy and safety results for this study. In the current presentation, Jayne reported outcomes regarding renal function. “Approximately 80% of [the 330 patients] have renal disease,” he said.
Eligible participants were randomly assigned placebo taper or avacopan, with cyclophosphamide (followed by azathioprine) or rituximab (Rituxan, Genentech) as background therapy.
Disease remission at week 26 and sustained remission at week 52 served as the primary outcome measure. Change from baseline through week 52 of glomerular filtration rate (eGFR) and urinary albumin:creatinine ratio served as key secondary outcomes.
The average baseline eGFR was 44.6 mL/min/1.73 m2 for 134 patients treated with avacopan and 45.6 mL/min/1.73 m2 for 134 patients treated with prednisone. “This data represents the recovery in eGFR with treatment among the two treatment groups,” Jayne said. “This was a pre-determined secondary endpoint of the trial.”
Week 52 results showed that avacopan yielded an eGFR increase of 7.3 mL/min/1.73 m2, while patients treated with prednisone only increased by 4.1 mL/min/1.73 m2. “As you can see, there was a significantly greater increase in eGFR in the avacopan group,” Jayne said.
Further week 52 findings concentrated on patients with lower baseline eGFR. Among those patients, the increase in eGFR was 12.7 mL/min/1.73 m2 in the avacopan group and 7.1 mL/min/1.73 m2 for prednisone (P < .01). “It shows that the difference in renal recovery is greater, suggesting that avacopan has more to offer in terms of the kidney in patients with worse renal disease,” Jayne said.
Patients with baseline eGFR < 30 mL/min/1.73 m2 who were treated with avacopan showed the most marked improvement in eGFR. In that group, the LSM increase was 13.7 mL/min/1.73 m2, compared with an improvement of just 8.2 mL/min/1.73 m2 for prednisone (P < .01)
The analysis also included patients with stage 4 chronic kidney disease at baseline, 52 of whom were treated with avacopan and 48 of whom received steroids. In the avacopan group, 50% improved one stage and 5.8% improved two stages. In the steroid group, 44% improved one stage and 2.1% improved two stages (P = .32).
“The significance of these observations is that the eGFR outcome, or the level of eGFR recovery, is thought to be predictive of the long-term end stage renal failure risk of the patient,” Jayne said.
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Jayne D. Abstract #L14. Presented at: ACR Convergence 2021; November 5-9, 2021 (virtual meeting).
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