ACHIEVEMENT OF PROTEINURIA LESS THAN 0.4 G/G IN THE PHASE 3 AURORA 1 STUDY OF VOCLOSPORIN IN LUPUS NEPHRITIS

O012 / #232 Topic: AS15 - Lupus Nephritis-Clinical ABSTRACT CONCURRENT SESSION 01: FINDINGS FROM LUPUS CLINICAL TRIALS 22-05-2025 1:40 PM - 2:40 PM Background/Purpose Reduction in urine protein creatine ratio (UPCR) is the cornerstone of the definition of treatment response in lupus nephritis. Treatment guidelines have incorporated various UPCR targets as goals of therapy, with UPCR <0.5 g/g being at the lower end.[1,2] However, studies demonstrate that low-grade proteinuria, even <0.5 g/g, is often associated with significant histologic activity.[3] Therefore, targeting lower UPCR levels may be beneficial to patients. Using data from the 52-week, Phase 3 AURORA 1 study in lupus nephritis, this post hoc analysis assessed achievement of UPCR targets <0.4 g/g with a voclosporin-based therapy. Methods Key inclusion criteria for the AURORA 1 study included biopsy-proven active LN, UPCR ≥1.5 g/g (≥2 g/g for class V) and estimated glomerular filtration rate (eGFR) >45 mL/min/1.73 m 2 ). Participants were randomized to either voclosporin (23.7 mg) or matching placebo (control) twice daily, in combination with MMF (target 2 g/day) and low-dose glucocorticoids (starting dose 20-25 mg/day, tapered to ≤2.5 mg/day by Week 16). Achievement at any study visit of UPCR targets <0.4 g/g, <0.3 g/g, <0.2 g/g, and <0.1 g/g was assessed. Baseline demographics, disease characteristics and safety outcomes are described for the subgroup of participants with UPCR <0.4 g/g at any study visit. Results Of the 357 participants in AURORA 1, 109 (60.9%) voclosporin-treated participants and 66 (37.1%) control-treated participants achieved a UPCR <0.4 g/g at least once during the 52-week study (Table 1). Of these 175 participants with UPCR <0.4 g/g, 87% were female, and mean (SD) age was 34 (11.2) years. A total of 13% had class III lupus nephritis, 49% had class IV, 16% had class V, and 40% had mixed disease. The median (range) time since diagnosis of lupus nephritis was 1.1 (0-27.0) years. The overall incidence of adverse events was similar between the 2 treatment groups (voclosporin, 89.9%; control, 83.3%). Mean eGFR remained stable and within the normal range in both groups (Figure 1). Table 1. Proteinuria Reductions Achieved in AURORA 1 Figure 1. Mean Corrected eGFR in Participants Achieving UPCR <0.4 g/g Conclusions Nearly half of the AURORA 1 population achieved a UPCR <0.4 g/g at least once during the 52-week study. Participants treated with voclosporin achieved lower UPCR targets at substantially higher rates than control-treated participants, with comparable rates of adverse events. These data provide initial evidence that targeting lower UPCR targets is feasible and enhanced with the use of voclosporin-based therapy. References: [1.] Rovin BH. Kidney Int 2024;105(1):31-4. [2.] Fanouriakis A. Ann Rheum Dis 2024;83(1):15-29. [3.] De Rosa M. Kidney Int Rep 2020;5(7):1066-8.

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