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Efficacy and safety of voclosporin vs placebo for lupus nephritis (AURORA 1): A double-blind, randomised, multicentre, placebo-controlled, phase 3 trial

The Lancet May 12, 2021

Rovin BH, Teng YKO, Ginzler EM, et al. - Researchers undertook this multicentre, double-blind, randomised phase 3 trial to assess voclosporin’s (a novel calcineurin inhibitor) efficacy as well as safety as a treatment option for lupus nephritis. Eligible 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, employing an interactive web response system. Findings revealed that a clinically and statistically superior complete renal response rate was conferred by voclosporin in combination with MMF and low-dose steroids, vs MMF and low-dose steroids alone, with a comparable safety profile. This observation is a crucial advancement in the management of active lupus nephritis cases.

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