New Drug Treatment Shows Efficacy for Lupus Kidney Disease

Data from the Phase III AURORA clinical trial that evaluated the effects of the experimental immunosuppressant drug, voclosporin, in the treatment of lupus nephritis, or lupus kidney disease, were recently presented at the National Kidney Foundation’s virtual Spring Clinicals Meetings. Results of the trial showed that the drug was effective in improving kidney function in patients with the disease. These results are encouraging as current treatments for lupus kidney disease often fail to prevent disease progression.

Voclosporin is an investigational drug that was developed by Aurinia Pharmaceuticals as a semi-synthetic structural analog of ciclosporin. Ciclosporin functions to inhibit T-cell-mediated immune responses by blocking the enzyme phosphatase calcineurin, which stimulates the production of the cytokine IL-2. Voclosporin has enhanced action against calcineurin, thereby leading to more effective suppression of T-cell immune responses; this leads to stabilization of cells called podocytes within the kidney’s Bowman capsule filtration component. The drug also has greater metabolic stability than ciclosporin.

AURORA (Aurinia Renal Response in Active Lupus With Voclosporin) is a global randomized, double-blind, placebo-controlled Phase III trial study that was designed to evaluate the addition of voclosporin to mycophenolate mofetil (MMF) and steroids, which are common treatments for lupus kidney disease. Findings of the study show that voclosporin improves outcomes in patients with active lupus kidney disease.

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The AURORA study involved the participation of 357 patients with active lupus nephritis to assess the efficacy and safety of voclosporin (23.7mg BID) in combination with mycophenolate (MMF, 2 g/day) and low-dose steroids compared to placebo.

The study found that patients who received voclosporin were able to achieve renal response (RR) rates (defined by proteinuria and eGFR renal indicators) within 52 weeks, which served as the primary endpoint of the study. Specifically, patients that received voclosporin were 2.65 times more likely to meet the criteria for RR compared to patients that received placebo. Early clinical response is key to maintaining kidney health long-term.

“We know that achieving remission status in lupus kidney disease correlates with good long-term kidney survival and so the results of this study are very encouraging,” said lead investigator Keisha L. Gibson, Associate Professor of Medicine and Pediatrics at the UNC Kidney Center.

Voclosporin was found to be well tolerated among patients and there was an overall low mortality rate in the trial. “There were no differences in the safety profile between the voclosporin and standard care group,” said Gibson.

Study participants who have completed the study will go on to a 2-year extension of the trial. The positive results of the study have led Aurinia to make plans to submit an application for FDA approval of the drug, which could help patients gain open access to it soon. Voclosporin appears to hold significant promise for use as an adjuvant in the treatment of the disease.