Voclosporin shows sustained renal response in patients with lupus nephritis
Patients with lupus nephritis (LN) treated with voclosporin maintained meaningful reductions in proteinuria after 2 years, according to data from an interim analysis of the AURORA 2 study presented at the European Alliance of Associations for Rheumatology (EULAR) 2021 Congress.
Patients who had completed 1-year treatment in the AURORA 1 study were eligible, with 116 patients randomized to receive treatment of voclosporin or and 100 to receive placebo in combination with mycophenolate mofetil (MMF) and low-dose oral steroids. At the time of this interim analysis, 73 patients in the voclosporin arm and 51 patients in the control arm had received 2 years of treatment.
At pre-treatment baseline, the mean UPCR was 3.94mg/mg in the voclosporin arm (n = 116) and 3.87mg/mg in the control arm (n = 100). From pre-treatment baseline to 2 years, the least squares (LS) mean change in urine protein creatinine ratio (UPCR) was -3.1mg/mg and -2.1mg/mg in the voclosporin arm (n = 73) and control arm (n = 51), respectively.
At pre-treatment baseline, mean estimated glomerular filtration rate (eGFR) was 79.6mL/min for the voclosporin arm (n = 116) and 78.9mL/min for the control arm (n = 100). At 2 years, mean eGFR was 79.0mL/min and 82.9mL/min in the voclosporin arm (n = 73) and control arm (n = 51), respectively.
In AURORA 1, researchers noted a small early decrease in mean eGFR during the first 4 weeks of treatment, however, eGFR remained stable for the remainder of years 1 and 2.
No new unexpected adverse events were observed.
Saxena A, et al. Voclosporin for lupus nephritis: Interim analysis of the Aurora 2 Extension study. Presented at: European Alliance of Associations for Rheumatology (EULAR) 2021 Congress.