Today February 18th 2021 the results of an important clinical study were published in the New England Journal of Medicine.
The trial was conducted from March 15, 2017, until November 1, 2019 (last trial visit).
In a phase 3 randomized trial (ADVOCATE) the avacopan product was compared with a tapering schedule of prednisone in patients with ANCA-associated vasculitis concurrently treated with immunosuppressive drugs.
Patients were enrolled at 143 centers in an international, randomized, double-blind, double-dummy, controlled trial. The aim was to evaluate whether avacopan could replace a glucocorticoid-tapering regimen used in the treatment of ANCA-associated vasculitis
Avacopan (30 mg twice daily) or matching placebo was given for 52 weeks, with 8 weeks of follow-up. Prednisone or a matched placebo was given on a tapering schedule for 20 weeks (60 mg per day tapered to discontinuation by week 21)
The conclusion as published was:
In this trial involving patients with ANCA-associated vasculitis, avacopan was noninferior but not superior to prednisone taper with respect to remission at week 26 and was superior to prednisone taper with respect to sustained remission at week 52. All the patients received cyclophosphamide or rituximab. The safety and clinical effects of avacopan beyond 52 weeks were not addressed in the trial.
According to the authors “Longer trials are required to determine the durability and safety of avacopan in patients with ANCA-associated vasculitis,”.
Source NEJM 18th Feb 2021