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.
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.