Phase II AURA-LV and Phase III AURORA 1 studies of Lupkynis shows efficacy in lupus nephritis.- Aurinia Pharmaceuticals

The pooled analysis from the Phase II AURA-LV and Phase III 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: at least 25% reduction in UPCR by three months, at least 50% reduction in UPCR by six months, UPCR of at most 0.7 mg/mg by 12 months, as well as steroid dose of at most 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 at least 25% reduction in UPCR (OR 2.25, p<0.0001). at six months, 66.0% of patients in the voclosporin group and 47.0% of patients in the control group achieved at least 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 of at most 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 at most 0.75 mg day according to the protocol-defined steroid taper (or 1.83, ci 1.03-3.27, p="0.0396)."></0.0001).></0.0001).></0.0001).>

In addition, the proportion of patients meeting UPCR of at most 0.7 and steroid dose of at most 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). 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).></0.0001).>