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1110 Voclosporin is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations
  1. Hans-Joachim Anders1,
  2. Ray Federico2,
  3. Simrat Randhawa2,
  4. Henry Leher2 and
  5. Elmar Orujov2
  1. 1Klinikum der Universität München, Munich, Germany
  2. 2Aurinia Pharmaceuticals Inc., Victoria, Canada


Background Pooled data from the Phase 2 AURA-LV and Phase 3 AURORA 1 studies demonstrated that adding voclosporin, a novel calcineurin inhibitor, to mycophenolate mofetil (MMF) and low-dose steroids resulted in significantly higher complete renal response rates at 24 weeks in AURA-LV (32.6% vs 19.3%; odds ratio [OR] 2.03; p=0.045) and 52 weeks in AURORA 1 (40.8% vs 22.5%; OR 2.65; p< 0.0001) in patients with lupus nephritis.

The European League Against Rheumatism and European Renal Association (EULAR/ERA) published updated treatment recommendations for lupus nephritis with targeted reductions in proteinuria over the course of the first year of therapeutic intervention. Here we report on a post-hoc analysis of pooled data from the similarly-designed 48-week AURA-LV and 52-week AURORA 1 studies based on the recommended treatment targets.

Methods AURA-LV and AURORA 1 enrolled patients with biopsy-proven active lupus nephritis (Class III, IV, or V ± III/IV) and proteinuria ≥1.5 mg/mg (≥2 mg/mg for Class V). Pooled data included 268 patients in the voclosporin arm and 266 patients in the control arm; all patients received MMF (target dose 2 g/day) and low-dose steroids (target dose 2.5 mg/day by week 16 according to protocol-defined steroid taper). We assessed the following EULAR/ERA treatment targets: ≥25% reduction in urine protein creatinine ratio (UPCR) at 3 months, ≥50% reduction in UPCR at 6 months, UPCR ≤0.7 mg/mg at 12 months, and steroid dose ≤7.5 mg/day at 12 months.

Results After 3 months of treatment, 78.4% of patients in the voclosporin group and 62.4% of patients in the control group achieved ≥25% reduction in UPCR (odds ratio [OR] 2.25; 95% confidence interval [CI] 1.52, 3.33; p< 0.0001). The percentage of patients achieving a reduction of ≥50% in UPCR at 6 months was significantly greater in the voclosporin arm (66.0% vs 47.0%, respectively; OR 2.24; CI 1.57, 3.21; p< 0.0001). At 12 months, 52.6% and 33.1% of the voclosporin and control arms, respectively, had achieved a UPCR ≤0.7 mg/mg (OR 2.52; CI 1.75, 3.63; p< 0.0001). A total of 89.6% and 82.8% of patients in the voclosporin and control arms, respectively, had reached the recommended steroid dose of ≤7.5 mg/day at 12 months. The proportion of patients achieving a UPCR ≤0.7 mg/mg and having a steroid dose ≤7.5 mg/day at 12 months was 44.4% in the voclosporin arm and 27.1% in the control arm (OR 2.42; CI 1.66, 3.53; p< 0.0001).

Conclusions The addition of voclosporin to a background regimen of MMF and low-dose steroids in patients with LN significantly increased the likelihood of achieving the 3-, 6-, and 12-month UPCR targets of therapy recommended by EULAR/ERA.

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