AURORA 1
Voclosporin for Lupus Nephritis (AURORA 1)
Paziente / Popolazione Intervento / Esposizione Confronto Esito
In 357 patients with active lupus nephritis, adding voclosporin to MMF and low-dose steroids increased complete renal response at week 52 compared with placebo.
N
357
Disegno
Phase 3 double-blind RCT
Esito
Complete renal response at week 52
Rilevanza
2
Risultato41% vs 23%; OR 2.65 (95% CI 1.64–4.27; p<0.0001).
Rovin BH, et al. Lancet. 2021;397(10289):2070-2080. 10.1016/S0140-6736(21)00578-X
Discussione e critica
Led to FDA approval of voclosporin; AURORA 2 showed the benefit sustained over 2 years.