Voclosporin improves complete renal response rates in patients with lupus nephritis

Voclosporin in combination with mycophenolate mofetil (MMF) and low-dose steroids led to a statistically superior complete renal response rate compared to MMF and low-dose steroids alone in patients with lupus nephritis, according to a study.

In this multicenter, double-blind, randomized Phase 3 trial, patients with class III, IV, V, or a combination with class III or IV lupus nephritis were randomly assigned to receive oral voclosporin (n = 179) or placebo (n = 178) on a background of MMF and rapidly tapered low-dose oral steroids. The primary endpoint of complete renal response at 52 weeks was achieved in 41% of patients in the voclosporin group compared to 23% in the placebo group (P < 0.0001).

Serious adverse events occurred in 21% of patients in both groups, with the most frequent event involving infection being pneumonia. Overall, 6 patients died during the study or follow-up period, although no deaths were considered related to the study treatment.

Reference
Rovin BH, Teng YKO, Ginzler EM, et al. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2021;S0140-6736(21)00578-X. doi: 10.1016/S0140-6736(21)00578-X.