ADVOCATE
Avacopan for ANCA-Associated Vasculitis
Patient / Population Intervention / Exposition Comparaison Critère de jugement
In 331 patients with ANCA-associated vasculitis, the oral C5a-receptor antagonist avacopan improved sustained remission at week 52 compared with a tapering prednisone regimen.
N
331
Schéma
Phase 3 double-blind RCT
Critère
Remission at week 26 and sustained remission at week 52
Pertinence
2
RésultatWeek 26 non-inferior (72.3% vs 70.1%); week 52 superior (65.7% vs 54.9%; p=0.007).
Jayne DRW, et al. N Engl J Med. 2021;384(7):599-609. 10.1056/NEJMoa2023386
Discussion et critique
Retracted in 2026. Nine primary-endpoint assessments were re-adjudicated after database lock and after unblinding, unknown to the two academic authors, who then asked the NEJM to withdraw the paper. The EMA found the trial in breach of good clinical practice and its data "incorrect and misleading", and the European Commission revoked the EU marketing authorisation in August 2026; the FDA had proposed withdrawal in April. Read as a record of what was claimed, not of what was shown.