0357: Voclosporin Is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations

Hans-Joachim Anders¹, Raymond Federico², Vanessa Birardi³ and Henry Leher³, ¹University of Munich, Munich, Germany, ²Aurinia Pharmaceuticals, Inc., Victoria, BC, Canada, ³Aurinia Pharmaceuticals Inc, Rockville, MD

Background/Purpose: 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 also 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).

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

Analysis includes pooled data from the voclosporin 23.7 mg BID and control arms in AURA-LV and AURORA 1. CI, confidence interval; OR, odds ratio; UPCR, urine protein creatinine ratio.

Analysis includes pooled data from thevoclosporin 23.7 mg BID and control arms in AURA-LV and AURORA 1.CI, confidence interval; OR, odds ratio; UPCR, urine protein creatinine ratio.
Disclosures: H. Anders, AstraZeneca, Novartis, Kezar, GSK, Otsuka, Janssen, Vifor, Bayer, Boehringer-Ingelheim, Aurinia; R. Federico, Aurinia Pharmaceuticals Inc.; V. Birardi, Aurinia Pharmaceuticals; H. Leher, Aurinia Pharmaceuticals.