Efficacy and safety of voclosporin vs placebo for lupus nephritis (AURORA 1): A double-blind, randomised, multicentre, placebo-controlled, phase 3 trial
The Lancet Jun 04, 2021
Rovin BH, Teng YKO, Ginzler EM, et al. - Via this multicentre, double-blind, randomised phase 3 trial, voclosporin (a novel calcineurin inhibitor) was tested for its efficacy and safety in the treatment of lupus nephritis. Patients were randomized (1:1) to oral voclosporin (23·7 mg twice daily) or placebo, on a background of mycophenolate mofetil (1 g twice daily) and rapidly tapered low-dose oral steroids. In the voclosporin group, significantly more patients achieved the primary endpoint of complete renal response at week 52, relative to the placebo group. Findings showed that a clinically and statistically superior complete renal response rate as well as a comparable safety profile were offered by voclosporin in combination with MMF and low-dose steroids when compared with MMF and low-dose steroids alone.
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