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

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Published:4th Jun 2022

Aurinia Pharmaceuticals 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).

 

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).>

Condition: Lupus Nephritis
Type: drug

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