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Abstract: TH-PO488

Long-Term Safety and Efficacy of Voclosporin in Patients With Lupus Nephritis and Low eGFR

Session Information

Category: Glomerular Diseases

  • 1303 Glomerular Diseases: Clinical‚ Outcomes‚ and Trials

Authors

  • Saxena, Ramesh, The University of Texas Southwestern Medical Center, Dallas, Texas, United States
  • Collins, Christopher Ellis, Aurinia Pharmaceuticals Inc, Victoria, British Columbia, Canada
  • Birardi, Vanessa, Aurinia Pharmaceuticals Inc, Victoria, British Columbia, Canada
  • Pavlova-Wolf, Anna, Aurinia Pharmaceuticals Inc, Victoria, British Columbia, Canada
Background

Voclosporin (VCS) is a novel calcineurin inhibitor approved for the treatment of adults with lupus nephritis. In the Phase 3 AURORA 1 study, addition of VCS to mycophenolate mofetil (MMF) and steroids increased rates of complete renal response at 1 year. Efficacy was maintained for an additional 2 years in the AURORA 2 continuation study. Here we report on a post-hoc analysis of the long-term safety and efficacy of VCS in patients with low estimated glomerular filtration rate (eGFR) at baseline using 3 years of pooled data from these studies.

Methods

Patients from AURORA 1 with a baseline eGFR >45 and <60 mL/min/1.73 m2 who also participated in AURORA 2 were included in this analysis. Patients completing AURORA 1 were eligible to enter AURORA 2 on the same blinded therapy (VCS or placebo) in combination with MMF and steroids. Urine protein creatinine ratio (UPCR) and eGFR changes from baseline were measured.

Results

The analysis included 27 patients with low eGFR (13 in the VCS arm and 14 in the control arm) of whom 23 completed 3 years of treatment (12 and 11 patients, respectively). Mean corrected eGFR at baseline for the VCS and control arms was 52.6 and 50.9 mL/min/1.73 m2, respectively. At 6 months, mean eGFR was 62.0 and 63.4 mL/min/1.73 m2 in each arm, respectively, and remained stable in both arms throughout the 3 years of treatment (Figure 1). Safety outcomes were comparable between arms and consistent with the overall study population. Mean UPCR at AURORA 1 baseline was 4.8 mg/mg in the VCS arm and 4.0 mg/mg for the control arm. At 3 months, mean UPCR decreased to 1.7 mg/mg and 2.5 mg/mg in each arm, respectively. Mean UPCR continued to improve throughout AURORA 1, and the reductions were maintained in AURORA 2 for both treatment arms.

Conclusion

In this post-hoc analysis of patients with lupus nephritis and low eGFR at baseline, patients treated with VCS achieved rapid and sustained reductions in proteinuria with no decrease in mean eGFR or unexpected adverse events during 3 years of treatment.

Funding

  • Commercial Support