Abstract: FR-PO640
Long-Term Use of Voclosporin in Patients With Class V Lupus Nephritis: Results From the AURORA 2 Continuation Study
Session Information
- Glomerular Diseases: Clinical, Outcomes, Trials - II
November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
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 – Aurinia Pharmaceuticals Inc.