AURORA-1: Voclosporin Efficacy in Lupus Nephritis Save
Lancet has published the results of the AURORA-1 trial, wherein the calcineurin inhibitor, voclosporin, was tested in a placebo controlled trial of lupus nephritis and shown to be effective at inducing a complete renal response.
This phase 3, 52-week, trial assessed the efficacy and safety of voclosporin in patients with biopsy proven lupus nephritis (class III, IV, or V GN). Patients were maintained on background mycophenolate mofetil (1 g twice daily) and oral steroids (with a scheduled taper. Patients were randomized to receive oral voclosporin (23·7 mg twice daily) or placebo. The primary endpoint was complete renal response at 52 weeks defined as a composite of urine protein creatinine ratio of 0·5 mg/mg or less, stable renal function, no need for rescue medication, and successful weaning of prednisone down to < 10 mg prednisone per day.
A total of 357 patients were randomized. The week 52 primary endpoint (complete renal response) was achieved by:
- Voclosporin 41%
- Placelbo - 23% (p<0·0001).
Serious adverse events were balanced between groups (21% vs 21%) - this included 7 cases of pneumonia with voclosporin and 8 cases with PBO.
There were 6 deaths during the study (1 voclosporin; 5 PBO).
The combination of voclosporin and MMF was effective and as safe as placebo in biopsy proven lupus nephritis patients.