Novel calcineurin inhibitor voclosporin maintained meaningful reductions in proteinuria, with a stable estimated glomerular filtration rate (eGFR), in patients with lupus nephritis, according to an interim analysis of the AURORA 2 extension study, presented at the American College of Rheumatology (ACR) Convergence 2021, held virtually from November 5 to 9, 2021.
Previously, phase 3 AURORA 1 and phase 2 AURA-LV studies suggested that voclosporin compared with mycophenolate mofetil and low-dose steroids alone significantly increased kidney response and reduced proteinuria in patients with lupus nephritis.
The current report provided data on the second interim analysis of the ongoing AURORA 2 study, a 2-year, blinded, and controlled extension study.
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All participants in the AURORA 1 trial had biopsy-proven lupus nephritis, and those who completed the 12 months’ trial were eligible to continue in the 18 months’ AURORA 2 trial with the same randomized treatment of voclosporin or placebo, in addition to mycophenolate mofetil and low-dose oral steroids.
The extension study included 116 patients in the voclosporin group and 100 patients in the placebo group. Of these, 90 patients in the treatment group and 78 patients in the placebo group had received 30 months of total treatment and were included in the current interim analysis.
Mean urine protein creatinine ratio at pretreatment baseline in AURORA 1 was 3.94 mg per mg in the voclosporin group and 3.87 mg per mg in the placebo group. Least-squares mean changes in urine protein creatinine ratio from pretreatment baseline to 30 months were -3.32 mg per mg for the voclosporin group and -2.55 mg per mg for the placebo group.
The researchers noted a small, expected, and early decrease in mean eGFR in the first 4 weeks of treatment in AURORA 1, after which the rates remained stable through month 30.
There were no unexpected new adverse events among individuals in the voclosporin group compared with those in the control group. Infection with COVID-19 was reported in 6 patients in the voclosporin group and 10 patients in the placebo group, with 2 and 6 patients, respectively, reporting serious COVID-19 infection.
“Patients in the voclosporin treatment arm maintained meaningful reductions in proteinuria with no change in mean eGFR at 30 months of treatment. Additional AURORA 2 efficacy and safety data will be provided at the conclusion of the study,” the researchers concluded.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Saxena A, Cohen S, Mela C, Coeshall A. Voclosporin for lupus nephritis: interim analysis of the AURORA 2 extension study. Presented at: ACR Convergence 2021; November 3-10, 2021. Abstract 1425.
This article originally appeared on Rheumatology Advisor
