In this two years, blinded controlled extension study, the researchers included patients who completed the AURORA 1study. They enrolled 116 patients in the voclosporin arm and 100 patients in the control arm enrolled in the extension study, of which 73 patients in the voclosporin arm and 51 patients in the control arm had received two years of treatment. The patients received either voclosporin (23.7 mg BID) or placebo, in combination with MMF (1 g BID) and low-dose oral steroids according to the randomization schedule. The researchers evaluated the urine protein creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR) in patients with up to two years of total treatment: one year from AURORA 1 and up to one year in AURORA 2.
Key findings of the study were:
- At the pre-treatment baseline (AURORA 1), the researchers noted that the mean UPCR was 3.94 mg/mg in the voclosporin arm and 3.87 mg/mg in the control arm.
- After 2 years, they found that the least-squares mean changes in urine protein creatinine ratio were –3.1mg per mg for those treated with voclosporin and –2.1mg per mg for the placebo group.
- At baseline, they noted that the mean eGFR was 79.6 mL/min for the voclosporin arm and 78.9 mL/min for the control arm.
- After 2 years, they found that the mean eGFR was 79.0 mL/min for the voclosporin arm (n=73) and 82.9 mL/min for the control arm (n=51).
- They observed a small early decrease in mean eGFR in the first four weeks of treatment (in AURORA 1), after which eGFR remained stable throughout year one and year two.
- Also, they reported no new unexpected adverse events in patients who continued with voclosporin treatment compared to control-treated patients for more than one year.
The authors concluded, "Patients in the voclosporin treatment arm maintained meaningful reductions in proteinuria with no change in mean eGFR at two years of treatment. Additional AURORA 2 efficacy and safety data will be provided at the conclusion of the study".
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