Voclosporin for lupus nephritis reduces proteinuria with no eGFR change
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Patients with lupus nephritis who receive voclosporin demonstrated “meaningful reductions” in proteinuria with no change in mean estimated glomerular filtration rate at 30 months, according to data presented at ACR Convergence 2021.
“For decades, patients and physicians have been challenged by a lack of dedicated, safe and effective treatment options for lupus nephritis,” Amit Saxena, MD, of the New York University School of Medicine, told Healio Rheumatology. “These data are significant as they reinforce the clinical value and safety of Lupkynis for up to 2.5 years.”
The findings come from the second interim analysis of AURORA 2, an ongoing 2-year, blinded, controlled extension study. Designed to analyze the impact of voclosporin (Lupkynis, Aurinia Pharmaceuticals) in patients with lupus nephritis for up to 30 months, the study follows the phase 3 AURORA 1 trial, which, alongside the phase 2 AURA-LV trial, suggested that adding voclosporin to standard care significantly increased the renal response rate and reduced proteinuria in patients with lupus nephritis at 1 year of treatment, compared with mycophenolate mofetil and low-dose steroids alone.
For AURORA 2, participants who completed all 12 months of the AURORA 1 study were eligible to continue with their randomized treatment — either 23.7 mg of voclosporin twice daily or placebo — in combination with 1 g of mycophenolate mofetil twice daily and low-dose oral steroids for an additional 18 months. In all, 116 participants in the voclosporin group and 100 patients in the placebo arm enrolled in the extension study.
For this analysis, the researchers assessed urine protein creatinine ratios (UPCR) and estimated glomerular filtration rates (eGFR) in the 90 participants in the voclosporin cohort, and the 78 in the placebo arm, who had received 30 months of total treatment at the time.
According to the researchers, the mean UPCR at pre-treatment baseline — in AURORA 1 — was 3.94 mg/mg in the voclosporin group and 3.87 mg/mg in the placebo group. The least squares mean change in UPCR from pre-treatment baseline to month 30 was –3.32 mg/mg for the voclosporin arm and –2.55 mg/mg for the placebo group.
The researchers recorded a small, expected and early decrease in mean eGFR among participants who received voclosporin during the first 4 weeks of treatment in AURORA 1. Later, in AURORA 2, eGFR remained stable through month 30 for these patients. The researchers reported no unexpected new adverse events in participants who continued with voclosporin, compared to those who received placebo.
A total of six participants in the voclosporin group and 10 in the placebo group developed COVID-19, with two and six patients, respectively, reporting serious coronavirus infections.
“The AURORA 2 continuation study provides the longest-available outcomes data with Lupkynis for the treatment of lupus nephritis to-date,” Saxena said. “As of this second interim analysis, we found patients in the voclosporin treatment arm maintained meaningful reductions in proteinuria with no change in mean eGFR, no new adverse events and no increases in hyperlipidemia or hyperglycemia at 30 months of treatment.”
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Saxena A. Abstract 1425. Presented at: ACR Convergence 2021; November 5-9, 2021 (virtual meeting).
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