ASN's Mission

To create a world without kidney diseases, the ASN Alliance for Kidney Health elevates care by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on X

Kidney Week

Please note that you are viewing an archived section from 2022 and some content may be unavailable. To unlock all content for 2022, please visit the archives.

Abstract: FR-PO640

Long-Term Use of Voclosporin in Patients With Class V Lupus Nephritis: Results From the AURORA 2 Continuation Study

Session Information

Category: Glomerular Diseases

  • 1303 Glomerular Diseases: Clinical‚ Outcomes‚ and Trials

Authors

  • Caster, Dawn J., University of Louisville, Louisville, Kentucky, United States
  • Saxena, Amit, NYU Langone Health, New York, New York, United States
  • Almaani, Salem, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
  • Rosales, Amber, Aurinia Pharmaceuticals Inc, Victoria, British Columbia, Canada
  • Leher, Henry, Aurinia Pharmaceuticals Inc, Victoria, British Columbia, Canada
Background

Persistent proteinuria increases risk of comorbidities in lupus nephritis (LN) and rapid reductions in protein are predictive of improved long-term renal health. Patients (pts) with Class V LN may take longer to respond to therapy and treatments that efficiently reduce proteinuria in this population are needed. We report on a post-hoc analysis of voclosporin in Class V LN using three years of data from the Phase 3 AURORA 1 and AURORA 2 studies.

Methods

AURORA 1 enrolled pts with biopsy-proven active LN, UPCR ≥1.5 mg/mg (≥2.0 mg/mg for pure Class V), and eGFR >45 mL/min/1.73 m2. Pts completing AURORA 1 were eligible to enter AURORA 2 on the same blinded therapy (voclosporin or placebo) in combination with MMF and low-dose steroids. Hazard ratios (HR) for the time to UPCR ≤0.5 mg/mg and mean eGFR levels were assessed in pts with mixed and pure Class V LN.

Results

A total of 80 Class V pts continued treatment into AURORA 2. Baseline UPCR was 3.7 and 3.4 mg/mg in control and voclosporin arms, respectively. Differences between treatment arms in UPCR reductions were apparent within the first month and sustained at three years; the median time to UPCR ≤0.5 mg/mg was 3.7 and 16.3 months in the voclosporin and control arms, respectively (HR 2.54; p=0.0004). Results were similar in pure and mixed Class V voclosporin arms; control arms took longer to reach the endpoint (Figure 1). Mean corrected eGFR levels were similar in all treatment arms and stable throughout the study (Figure 1).

Conclusion

Voclosporin-treated pts with Class V LN saw substantial reductions in UPCR that occurred faster than in pts treated with MMF and low-dose steroids alone. Voclosporin may be beneficial in limiting the negative long-term impact of proteinuria in this population.

Funding

  • Commercial Support –