Voclosporin, a calcineurin inhibitor, was compared to a placebo in a study involving patients with lupus nephritis (LN). This phase 2 clinical trial, named AURA-LV, aimed to evaluate the efficacy and safety of voclosporin in combination with standard treatment for LN. Participants were given either a low dose (23.7 mg twice daily) or a high dose (39.5 mg twice daily) of voclosporin, or a placebo, alongside mycophenolate mofetil (2 g/d) and tapered corticosteroids.
The primary endpoint was complete renal remission (CRR) at 24 weeks. Secondary endpoints included CRR at 48 weeks. The study enrolled 265 individuals across 79 centers and 20 countries, randomly assigning them to one of the three treatment groups.
Results showed a significantly higher CRR rate in the low-dose voclosporin group (32.6%) compared to the placebo group (19.3%) at 24 weeks. This improvement persisted at 48 weeks. The high-dose voclosporin group (27.3% at 24 weeks) also demonstrated a significantly higher CRR rate than the placebo group at 48 weeks.
While the addition of voclosporin demonstrated improved renal outcomes, it’s important to note the safety profile. Both voclosporin groups experienced a higher incidence of serious adverse events. Furthermore, the low-dose voclosporin group had a higher mortality rate (11.2%) compared to the placebo (1.1%) and high-dose voclosporin (2.3%) groups.
In conclusion, this study comparing voclosporin to a placebo suggests that adding low-dose voclosporin to standard LN treatment (mycophenolate mofetil and corticosteroids) may improve renal response. However, the increased risk of adverse events, including death, warrants careful consideration. Further research is necessary to confirm these findings and to determine the optimal dose and long-term safety profile of voclosporin for LN treatment.
