AURORA 2: Voclosporin sustains proteinuria reduction in lupus nephritis at 2 years
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Patients with lupus nephritis who received voclosporin maintained “meaningful” reductions in proteinuria, with stable mean estimated glomerular filtration rates, at 2 years, according to a poster session at the EULAR 2021 Virtual Congress.
The findings represent the first interim data from an extension of the previously reported phase 3 AURORA 1 study, which, alongside the phase 2 AURA-LV trial, suggested that adding voclosporin (Lupkynis, Aurinia Pharmaceuticals) 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 decades, physicians and patients have been challenged by a lack of dedicated, safe and effective treatment options for lupus nephritis,” Amit Saxena, MD, of New York University Langone Health, told Healio Rheumatology. “Voclosporin was recently FDA-approved based on phase 2 and 3 data showing superiority compared to standard of care treatment in complete renal response. However, to date, longer-term efficacy and safety of voclosporin has not yet been evaluated beyond 1 year.”
To analyze the impact of voclosporin in patients who participated in AURORA 1 at 2 years, Saxena and colleagues conducted AURORA 2, a two-year blinded, controlled extension study, which is still ongoing. Participants who completed 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 this interim analysis, the researchers assessed participants’ urine protein creatinine ratio and estimated glomerular filtration rate (eGFR) from the first year of the AURORA 2 study — a total of 2 years after the initial treatment in AURORA 1. In all, 116 participants in the voclosporin group and 100 patients in the placebo arm enrolled in the extension study. Among these patients, 73 in the voclosporin group and 51 who received a placebo had received 2 years of treatment at the time of the interim analysis.
According to the researchers, the mean urine protein creatinine ratio at pre-treatment baseline in AURORA 1, among the participants who entered the extension, was 3.94mg per mg in the voclosporin group and 3.87mg per mg in the placebo arm. Among those included in the interim analysis, the least squares mean changes in urine protein creatinine ratio from pre-treatment baseline to year 2 were –3.1mg per mg for those treated with voclosporin and –2.1mg per mg for the placebo group.
Meanwhile, mean eGFR at pre-treatment — or AURORA 1 baseline — among participants who entered the extension was 79.6mL per minute for the voclosporin group and 78.9mL per minute for the placebo arm. At year 2, among those included in the interim analysis, mean eGFR was 79mL per minute in the voclosporin group and 82.9mL per minute for those who received a placebo. The researchers noted a small early decrease in mean eGFR in the first 4 weeks of treatment in AURORA 1, after which the rates remained stable throughout years 1 and 2.
There were no unexpected new adverse events in patients who continued with voclosporin, compared with the placebo group, for more than 1 year, according to researchers.
“The AURORA 2 continuation study provides the longest-available outcomes data with voclosporin for the treatment of lupus nephritis to date,” Saxena said. “This study evaluated patients with up to 104 days of total treatment — one year from AURORA 1 and up to one year in AURORA 2 — and found patients in the voclosporin treatment arm maintained meaningful reductions in proteinuria, with no change in mean eGFR and no unexpected adverse events at two years of treatment. These data are significant as they reinforce the clinical value and safety of voclosporin for up to 2 years.”
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Saxena A. Abstract POS0681: Voclosporin for lupus nephritis: Interim analysis of the AURORA 2 extension study. Presented at: EULAR 2021 Virtual Congress; June 2-5, 2021 (virtual meeting).
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