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Abstract: TH-PO486

Voclosporin for Lupus Nephritis: Assessment of Long-Term Safety and Efficacy Including Renal Outcome Over 3 Years of Treatment in the Phase 3 AURORA 1 and AURORA 2 Studies

Session Information

Category: Glomerular Diseases

  • 1303 Glomerular Diseases: Clinical‚ Outcomes‚ and Trials

Authors

  • Parikh, Samir V., The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
  • Arriens, Cristina, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States
  • Hodge, Lucy S., Aurinia Pharmaceuticals Inc, Victoria, British Columbia, Canada
  • Mela, Christopher, Aurinia Pharmaceuticals Inc, Victoria, British Columbia, Canada
  • Leher, Henry, Aurinia Pharmaceuticals Inc, Victoria, British Columbia, Canada
Background

In AURORA 1, adding voclosporin to mycophenolate mofetil (MMF) and low-dose steroids led to significant reductions in proteinuria at 1 year in patients with lupus nephritis (LN). We report on the recently completed AURORA 2 study evaluating voclosporin compared to placebo in patients treated for an additional 2 years after AURORA 1.

Methods

Patients with LN completing AURORA 1 were eligible to continue on the same double-blinded treatment of voclosporin or placebo in AURORA 2; all patients recieved MMF and low-dose steroids. Outcomes assessed over the 3 year treatment period of both studies included adverse events (AEs), eGFR, urine protein-creatinine ratio (UPCR), good renal outcome and renal flare. Good renal outcome was defined based on achievement of an adequate response (i.e. sustained reduction in UPCR to ≤0.7 mg/mg) and without renal flare (i.e. an increase to UPCR >1 mg/mg from a post-response UPCR of <0.2 mg/mg or an increase to UPCR >2 mg/mg from a post-response UPCR of 0.2 to 1.0 mg/mg), as adjudicated by a blinded Clinical Endpoints Committee.

Results

Overall rates of serious AEs in the voclosporin (26.7% of 116 patients) and control arm (28.0% of 100 patients) were similar. There were no deaths in the voclosporin arm during AURORA 2; four deaths occured in the control arm (pulmonary embolism, n=1; coronavirus infection, n=3). Mean corrected eGFR was within the normal range and stable over the study period. The reductions in UPCR achieved in AURORA 1 were maintained in AURORA 2 and significantly more patients in the voclosporin arm achieved a good renal outcome (66.4% in voclosporin vs 54.0% in control; p-value=0.045). Renal flare occurred in 24 of 101 patients with adequate response in the voclosporin arm and 19 of 73 patients in the control arm (23.8% in voclosporin vs 26.0% in control; p-value=0.662); 69.8% of all patients with renal flares completed study treatment.

Conclusion

Voclosporin was well-tolerated over three years of treatment. The significant reductions in proteinuria initially achieved in AURORA 1 were maintained throughout AURORA 2 and more patients in the voclosporin arm achieved a good renal outcome. These data provide evidence of a long-term treatment benefit of voclosporin in patients with lupus nephritis.

Funding

  • Commercial Support –