Background and Aims In lupus nephritis (LN), complete remission (CR) or partial remission is associated with better patient and renal survival. Subjects who do not achieve a 25% reduction in proteinuria within 8 weeks of starting induction immunosuppression are unlikely to achieve even a PR. Voclosporin (VCS) is a novel CNI demonstrating less pharmacokinetic–pharmacodynamic variability and a potentially improved safety profile compared with other CNIs.
Methods Entry criteria renal biopsy within 24 months (Class III; IV-S, IV-G (A) or (A/C); V, III/V, IV/V, ISN/RPS); urine protein:creatinine ratio (UPCR) ≥1.0 mg/mg (III/IV) or UPCR ≥1.5 mg/mg (V); serologic evidence of active LN; and eGFR >45 mL/min/1.73m2. AURION assessed the ability of biomarkers at 8 weeks to predict clinical response over 24 and 48 weeks when taking voclosporin (VCS) 23.7 mg po BID in combination with MMF (1–2 g/day) and reducing corticosteroid dose. We report 24 week data.
Results In this study, 7/10 (70%) subjects achieved CR at 24 weeks. Of the 10 subjects that achieved a≥25% reduction in UPCR at 8 weeks, 80% were responders (61% reduction in UPCR over baseline) at 24 weeks. In addition, inflammatory markers such as C3, C4 and anti-dsDNA all continued to normalise to 24 weeks. Renal function remained stable. VCS was well-tolerated with no unexpected safety signals observed.
Conclusions The results suggest that early response to therapy of VCS in combination with MMF may predict 24 week CR in the presence of low steroids in active LN. 48 week CR data will be presented at the meeting.
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