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Abstract: PO1917

Management of Lupus Nephritis (LN) with Voclosporin: An Update from a Pooled Analysis of 534 Patients

Session Information

Category: Glomerular Diseases

  • 1203 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Rovin, Brad H., The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
  • Parikh, Samir V., The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
  • Huizinga, Robert B., Aurinia Pharmaceuticals Inc, Victoria, British Columbia, Canada
  • Solomons, Neil, Aurinia Pharmaceuticals Inc, Victoria, British Columbia, Canada
  • Randhawa, Simrat, Aurinia Pharmaceuticals Inc, Victoria, British Columbia, Canada
Background

Voclosporin (VCS) is a novel calcineurin inhibitor (CNI) with a favorable metabolic profile and a consistent, predictable dose response potentially eliminating the need for therapeutic drug monitoring. VCS significantly improved renal response (RR) in patients with LN in two pivotal trials. Compared to MMF (target dose 2g/day) and prednisone (rapid taper), the addition of VCS 23.7 mg BID increased renal response by 25% in the Phase 2 AURA-LV (OR: 3.21; 95% CI: 1.68, 6.13; p < 0.001) and 18% in the Phase 3 AURORA (OR: 2.65; 95% CI: 1.64, 4.27; p < 0.001) studies at one year. To provide more information on VCS treatment effect we analyzed an integrated data set from AURA-LV and AURORA.

Methods

The two pivotal trials were of similar design, conducted in comparable patient populations and defined similar key outcome measures. The integrated data set included an intent to treat (ITT) population of 266 control and 268 VCS 23.7 mg/BID patients. Here we report key integrated data of interest including renal response, defined as:
● UPCR ≤ 0.5 mg/mg
● eGFR ≥ 60 mL/min or no decline > 20% from baseline
● ≤10 mg prednisone 8 weeks prior to endpoint measurement
● No rescue medications

Results

RR at one year was 43.7% for VCS vs 23.3% for control (OR 2.76, 95% CI: 1.88, 4.05; p < 0.0001), and at 6 months (VCS 31.7%; control 20.3%), [OR: 2.01; 95% CI: 1.34, 3.01; p = 0.0008]. In addition, 1-year RR for Hispanic patients was 37.9% in VCS arm vs 19.4% control. As expected, the largest estimated eGFR change from baseline for VCS vs control-treated patients occurred early, at week 4, (-5.6 mL/ min, p < 0.0001) which decreased to -3.7 mL/min by week 52 (p = 0.0012). Mean change from baseline of eGFR in the VCS arm at week 52 was -1.0 mL/min (p=ns). Finally, serious adverse events were similar between groups (22.8% VCS vs 18.8% control).

Conclusion

This integrated analysis provides further support to the efficacy of VCS seen in both AURA-LV and AURORA including in Hispanic patients, a high-risk LN patient population. Furthermore, VCS’ expected impact on mean eGFR as a CNI was mild over the course of one year.

Funding

  • Commercial Support