medwireNews: Voclosporin has a sustained proteinuria-reducing effect in patients with lupus nephritis, suggests an interim analysis of the AURORA 2 study.
The phase 3 double-blind study is a 2-year extension of the previously reported AURORA 1 study, comparing the calcineurin inhibitor voclosporin 23.7 mg twice a day with placebo as an add on to mycophenolate mofetil 2.0 g/day and low-dose steroid treatment.
The analysis, presented by Amit Saxena (NYU Langone Health, New York, USA) at the ACR Convergence 2021 virtual meeting, included integrated data from both AURORA 1 and 2 for 216 patients who continued on the same treatment for up to 30 months.
The average urine protein creatinine ratio at baseline was 3.9 mg/mg in both groups of patients at the start of AURORA 1. This had decreased to 0.90 mg/mg among patients in the voclosporin treatment group by the beginning of the AURORA 2 study and decreased further still to 0.58 mg/mg among the 90 evaluable patients at 30 months. This compared with a corresponding reduction from 1.5 to 1.3 mg/mg among the 78 patients taking placebo.
The outcomes for complete renal response rate will be available at the end of the study when the additional components of this composite outcome have been evaluated, Saxena commented.
He reported that there were “no unexpected new adverse events” among patients in the voclosporin group, with similar rates of serious adverse events reported, at 26.7% with voclosporin and 29.0% with placebo.
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