Voclosporin Study Findings

Voclosporin, a novel calcineurin inhibitor (CNI), has been tested successfully in 2 pivotal trials in adult patients with lupus nephritis (LN). AURORA 2 is a 2-year extension study of AURORA 1. Based on AURORA 1 study findings, the FDA approved voclosporin for the treatment of lupus nephritis. Recent interim analysis of the AURORA 2 trial shows a meaningful effect in lupus nephritis with no change in mean eGFR at 30 months. The study findings were presented at the ACR Convergence 2021 virtual meeting and published in the journal American College of Rheumatology.

Previous study findings from the Phase 3 AURORA 1 and Phase 2 AURA-LV studies showed that the addition of voclosporin with mycophenolate mofetil (MMF) and low-dose steroids significantly increased the renal response rate and reduced proteinuria in patients with LN at 48 weeks in AURA-LV and 52 weeks in AURORA 1. In this 2-year extension study, Dr. Amit Saxena and his team further evaluated the effect of voclosporin with placebo for the achievement of complete renal response used in combination with mycophenolate and low-dose steroids.

AURORA 2 is a 2-year, blinded, controlled extension study of AURORA 1, with exposure up to 30 months (12 months from AURORA 1 and up to an additional 18 months in AURORA 2). Patients with systemic lupus erythematosus who completed AURORA 1 (n=216) continued in their same treatment group, with 116 in the voclosporin group (23.7 mg BID) and 100 in the placebo group in combination with MMF (1 g BID) and low-dose oral steroids. As of this interim analysis, 90 and 78 patients, respectively, had received 30 months of total treatment. The researchers evaluated urine protein creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR).

Key Findings of the Study Were:

• At baseline, the UPCR at pre-treatment (AURORA 1) was 3.94 mg/mg in the voclosporin arm (n=116) and 3.87 mg/mg in the control arm (n=100).
• Upon analysis, they found that the mean change in UPCR from pre-treatment baseline to month 30 was -3.32 mg/mg for the voclosporin arm (n=90) and -2.55 mg/mg for the control arm (n=78).
• They also noted a small, expected and early decrease in mean eGFR in the voclosporin arm in the first 4 weeks of treatment in AURORA 1, after which eGFR remained stable through month 30.
• They found no new unexpected adverse events reported in patients who continued voclosporin treatment compared to control-treated patients.
• They reported a total of 6 and 10 events of coronavirus (COVID-19) infection in the voclosporin and control arms, among which 2 and 6 events were serious coronavirus infections.

The authors concluded, "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."

For further information:

Saxena A, Mela C, Coeshall A. Voclosporin for Lupus Nephritis: Interim Analysis of the AURORA 2 Extension Study [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). https://acrabstracts.org/abstract/voclosporin-for-lupus-nephritis-interim-analysis-of-the-aurora-2-extension-study/. Accessed November 12, 2021.