Aurinia Pharmaceuticals Inc. presented data demonstrating the efficacy of LUPKYNIS® (voclosporin) for the treatment of people with lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE), in achieving the proteinuria treatment targets recommended by the European Alliance of Associations for Rheumatology (EULAR) and the European Renal Association (ERA). A post-hoc analysis of pooled data from the similarly designed 48-week AURA-LV and 52-week AURORA 1 studies were presented in an oral session at the EULAR 2022 European Congress of Rheumatology by Hans-Joachim Anders, M.D., Professor of Nephrology at the University of Munich (LMU). The pooled analysis from the Phase 2 AURA-LV and Phase 3 AURORA 1 studies assessed the efficacy of voclosporin, in addition to mycophenolate mofetil (MMF) and low-dose steroids, to reduce urine protein creatinine ratio (UPCR) to achieve the following EULAR/ERA treatment targets updated in 2019: =25% reduction in UPCR by three months, =50% reduction in UPCR by six months, UPCR =0.7 mg/mg by 12 months, as well as steroid dose of =7.5 mg/day at 12 months.

The breakdown of the reductions in UPCR at month three, six, and 12 is as follows: At three months, 78.4% of patients in the voclosporin group and 62.4% of patients in the control group achieved =25% reduction in UPCR (OR 2.25, ??CI 1.52-3.33, p<0.0001). At six months, 66.0% of patients in the voclosporin group and 47.0% of patients in the control group achieved =50% reduction in UPCR (OR 2.24, CI 1.57-3.21, p<0.0001). At 12 months, 52.6% of patients in the voclosporin group and 33.1% of patients in the control group achieved UPCR =0.7 mg/mg (OR 2.52, CI 1.75-3.63, p<0.0001).

At 12 months, 89.6% of the voclosporin group and 82.8% of the control group achieved the recommended steroid dose of =0.75 mg/day according to the protocol-defined steroid taper (OR 1.83, CI 1.03-3.27, p=0.0396). In addition, the proportion of patients meeting UPCR =0.7 and steroid dose =7.5 mg/day was 44.4% in the voclosporin group and 27.1% in the control group (OR 2.42, CI 1.66-3.53, p<0.0001).