The AURORA 2 Extension Study, which examined the effect of adding the novel calcineurin inhibitor (CNI) voclosporin to a mycophenolate mofetil (MMF) and low-dose steroid routine for patients with lupus nephritis (LN), showed that “patients in the voclosporin treatment arm maintained meaningful reductions in proteinuria with no change in mean eGFR at 30 months of treatment,” according to the authors of a recent interim analysis.

There were also no new adverse events reported from this cohort.

This analysis was presented at the American College of Rheumatology (ACR) 2021 Convergence by Amit Saxena, MD, of the NYU School of Medicine.

The AURORA 2 Extension Study is an ongoing 2-year, blinded, controlled study continuing to investigate the effect of the addition of voclosporin to MMF and low-dose steroids for patients with lupus nephritis. Previous results from the phase 3 AURORA 1 (52 weeks) and phase 2 AURA-LV (48 weeks) studies showed that, when compared to MMF and low-dose steroids alone, the addition of voclosporin significantly increased the renal response rated and reduced proteinuria, as measured by urine protein/creatinine ratio (UPCR).

Patients in the AURORA 1 study all had a diagnosis of systemic lupus erythematosus according to the ACR criteria and biopsy-proven LN. Upon completion of AURORA 1, all patients were eligible to continue with the same randomized treatment of voclosporin (23.7 mg BID) or placebo, in combination with MMF (1 g BID) and low-dose oral steroids. There were 116 patients from the voclosporin treatment arm that continued and 100 patients from the control arm. At the time of the interim analysis, 90 patients from the voclosporin arm and 78 from the control arm had received a total of 30 months of treatment.

For this second interim analysis, the UPCR and estimated glomerular filtration rate (eGFR) of patients were evaluated 12 months after the completion of AURORA 1, and up to 18 additional months in AURORA 2. Pretreatment (AURORA 1) UPCR baseline for the voclosporin arm had a mean of 3.94mg/mg, while the control arm had a mean of 3.87 mg/mg. While there was a small decrease in mean eGFR in the voclosporin arm in the first 4 weeks of treatment in AURORA 1, this was expected and the eGFR has otherwise remained stable through month 30.

Researchers also noted that 16 total patients reported events of coronavirus infection (6 in the voclosporin treatment arm and 10 in the control arm), with 8 patients (2 from the treatment arm and 6 from the control arm) reporting serious coronavirus infections.

With 30 months of treatment, patients in voclosporin treatment arm of the AURORA 2 Extension study showed a greater reduction of proteinuria in comparison to the control arm. Additional efficacy and safety data from AURORA 2 will be provided at the conclusion of the study.

—Allison Casey

Reference:

Saxena A, et al. Voclosporin for lupus nephritis: Interim analysis of the AURORA 2 extension study. Presented at: The American College of Rheumatology Convergence meeting. November 12-15; virtual.