Long-term safety and efficacy of voclosporin in Asian patients with lupus nephritis: A post hoc analysis of the AURORA 2 trial.

OBJECTIVES

To investigate the long-term safety and efficacy of voclosporin in Asian patients with lupus nephritis who completed the AURORA 1 phase III study and enrolled in the AURORA 2 phase III continuation study.

METHODS

This post hoc analysis included 3 years of pooled data (AURORA 1 and AURORA 2). The double-blinded voclosporin or control treatment assigned in AURORA 1 was continued in AURORA 2. Safety and efficacy (renal response) were evaluated.

RESULTS

Sixty Asian patients were included (voclosporin, n = 30; control, n = 30). Adverse events occurred in 93.3 and 100.0% of voclosporin-treated and control patients, respectively. More patients in the voclosporin vs control group experienced decreased glomerular filtration rate (26.7 vs. 6.7%) and hypertension (33.3 vs. 10.0%); rates of study drug discontinuation due to adverse events were also lower (3.3 vs. 26.7%). Respective rates of urine protein creatinine ratio ≤0.5 mg/mg achievement were 90.0 and 56.7%; median time to achievement was significantly shorter with voclosporin (6.3 vs. 26.7 months; P = .001). Safety and efficacy were similar to the AURORA 2 overall population.

CONCLUSIONS

Asian patients with active lupus nephritis had sustained proteinuria reductions and a shorter time to proteinuria reduction with voclosporin versus control; voclosporin was well-tolerated.