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ACR 2020 | Daily Highlights
Avacopan in ANCA-vasculitis
THE EFFECT ON RENAL FUNCTION OF THE COMPLEMENT C5A RECEPTOR INHIBITOR AVACOPAN IN ANCA-ASSOCIATED VASCULITIS
Abstract: 0432
Authors: Peter Merkel et al.
Key content:
Avacopan, an oral, selective antagonist of C5aR, was recently evaluated in a pivotal phase 3 RCT in ANCA-associated vasculitis. 330 subjects were randomized 1:1 to receive either standard prednisone therapy or avacopan 30 mg twice daily. Both treatment groups received either cyclophosphamide followed by azathioprine, or rituximab. The primary efficacy endpoints were the proportion of subjects achieving disease remission at Week 26, and sustained disease remission at Week 52 as measured by the Birmingham Vasculitis Activity Score (BVAS). Renal function was assessed based on the estimated glomerular filtration rate (eGFR), and albuminuria, based on the albumin:creatinine ratio.
Results: Remission at week 26 and at week 52 were significantly better for avacopan vs. prednisone. Time to relapse from time of remission (BVAS=0) was longer for the avacopan group and the hazard ratio of time to relapse for avacopan:prednisone was 0.46, (95% confidence interval: 0.25, 0.84). Efficacy was observed across newly-diagnosed vs. relapsed disease, PR3- vs. MPO-ANCA, granulomatosis with polyangiitis vs. microscopic polyangiitis, cyclophosphamide vs. rituximab, and men vs. women.
In subjects with renal disease at baseline, the avacopan group had a greater increase in eGFR vs. the prednisone group. The difference was greatest in subjects with a baseline eGFR < 30 mL/min/1.73 m2. There was a more rapid reduction in albuminuria in the avacopan group (-40%) compared to no change in the prednisone group at 4 weeks; the overall reduction at week 52 was similar between groups. The avacopan group had a favorable safety profile compared to the prednisone group.
Relevance:
Avacopan offers a new treatment option in ANCA-associated vasculitis (of note: on top of conventional treatment with either cyclophosphamide or rituximab). The new data on a favorable outcome regarding kidney function is of particular interest, as ANCA vasculitis very frequently attacks and relapses in the kidney. However, whether this effect translates into a substantial delay in end-stage renal disease will have to be shown, probably best with data of registries.
Zusammenfassung und Kommentar von:
Prof. Dr. Peter Villiger
Bern
