Abstract: TH-OR29
Repeat Kidney Biopsies from the AURORA 2 Study of Voclosporin in Active Lupus Nephritis
Session Information
- Glomerular Diseases: Clinical and Translational Studies
November 02, 2023 | Location: Room 103, Pennsylvania Convention Center
Abstract Time: 05:42 PM - 05:51 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Trials
Authors
- Parikh, Samir V., The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
- Abner, Clint, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
- Yap, Ernie, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
- Piper, Krista, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
- Huizinga, Robert B., Reformation Consulting Services, North Saanich, British Columbia, Canada
- Leher, Henry, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
Background
Voclosporin is approved for the treatment of adults with active lupus nephritis (LN). Addition of voclosporin to MMF and low-dose glucocorticoids in the Phase 3 global AURORA studies led to significantly earlier and greater reductions in proteinuria while maintaining stable renal function. To characterize the long-term renal impact of voclosporin at the histologic level, we analyzed repeat kidney biopsies from a subset of patients in these studies.
Methods
Patients in AURORA 1 had biopsy-proven LN, UPCR ≥1.5 g/g (≥2 g/g for Class V), and eGFR >45 mL/min/m2. Patients were randomized to voclosporin or control for 1 year in AURORA 1 and continued the same blinded therapy for 2 additional years in AURORA 2; all patients received MMF and low-dose glucocorticoids. A subset of patients had a kidney biopsy prior to screening and a repeat biopsy after approximately 18 months of therapy. Histopathologic grading according to NIH indices for LN activity and chronicity was conducted by Arkana Laboratories. Efficacy outcomes and mean eGFR over time were assessed.
Results
Repeat biopsy samples were collected from 16 patients in the voclosporin arm and 10 patients in the control arm. Baseline mean activity scores were similar between arms, with scores improving with treatment in both arms. Mean chronicity scores were also similar between arms at baseline and remained stable over time in most patients. Measures of renal function remained stable in both arms over the 3-year follow-up . Voclosporin-treated patients had numerically greater mean reductions from baseline in UPCR year-on-year compared to patients in the control arm.
Conclusion
As expected, mean activity scores improved in both treatment arms. Importantly, exposure to voclosporin was not associated with chronic injury, with the mean index remaining stable at follow-up. Similar to the overall population, patients treated with voclosporin saw greater reductions in UPCR over 3 years of treatment; safety outcomes from this small subgroup were also consistent with outcomes in AURORA 1.
Funding
- Commercial Support – Aurinia Pharmaceuticals Inc.