Abstract: SA-PO876
Long-Term Safety and Efficacy of Voclosporin in Black Patients with Lupus Nephritis
Session Information
- Glomerular Diseases: Therapeutics
November 04, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Trials
Authors
- Contreras, Gabriel, University of Miami Health System, Miami, Florida, United States
- Baker, Matthew G., Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
- Hodge, Lucy S., Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
- Yap, Ernie, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
Background
Black patients with lupus nephritis (LN) are reported to have more severe disease, are often refractory to treatment, and have worse long-term outcomes. Voclosporin in conjunction with low-dose glucocorticoids and mycophenolate mofetil (MMF) has shown significant benefit across ancestries and classes of LN. Here we report outcomes on up to three years of follow-up in patients identifying as Black and treated with voclosporin during the global Phase 3 AURORA studies.
Methods
Key inclusion criteria for the parent AURORA 1 study included biopsy-proven LN, urine protein creatinine ratio (UPCR) ≥1.5 g/g (≥2 g/g for Class V) and estimated glomerular filtration rate (eGFR) >45 mL/min/1.73 m2. Patients completing AURORA 1 were eligible to enter the AURORA 2 continuation study on the same blinded therapy of voclosporin or placebo in combination with MMF and glucocorticoids for an additional two years. Programmed complete renal response (CRR; UPCR ≤0.5 g/g, stable eGFR, low-dose steroids, and no rescue medication), partial renal response (PRR; reduction in UPCR of ≥50% from baseline) and safety were assessed in patients self-identifying as Black or mixed Black.
Results
Twenty-six of 179 (14.5%) and 19 of 178 (10.6%) patients identified as Black or mixed Black in the voclosporin and control arms of AURORA 1. Baseline characteristics were similar between arms. CRR rates at one year numerically favored voclosporin (46.2% vs 15.8%, OR 3.92 [CI 0.95, >9.99] p=0.0597) as did PRR rates (69.2% vs 47.4%, OR 2.62 [CI 0.72, 9.45] p=0.1422).
Eighteen voclosporin-treated patients and seven control-treated patients in the Black subgroup continued into AURORA 2. Response rates at three years continued to numerically favor voclosporin (CRR, 44.4% vs. 14.3%, OR 4.17 [CI 0.41, >9.99] p=0.2276; PRR, 66.7% vs. 42.9%; OR 1.67 [CI 0.23, >9.99] p=0.6094). Greater reductions in mean UPCR were observed over the three-year period in the voclosporin arm (change from baseline -3.4 vs -1.5 g/g, p=0.0349). Mean eGFR levels remained stable and in the normal range over three years of treatment.
Conclusion
Black patients treated with a voclosporin-based regimen achieved higher rates of renal response than patients treated with MMF and glucocorticoids alone. For patients entering the continuation study, the response was largely durable for up to 3 years.
Funding
- Commercial Support – Aurinia Pharmaceuticals Inc.