Voclosporin Maintains Proteinuria Reduction & eGFR in Lupus Nephritis
Voclosporin, a novel calcineurin inhibitor (CNI), has been tested successfully in two pivotal trials in adult patients with lupus nephritis. A recent interim analysis suggests that voclosporin sustains proteinuria reduction and eGFR in patients with lupus nephritis. The findings of the interim analysis were presented at the EULAR 2021 Virtual Congress.
The US FDA has recently approved voclosporin (LUPKYNIS), based on phase 2 and 3 data showing superiority compared to standard of care treatment in complete renal response. However, "The long-term safety and efficacy data of voclosporin has not yet been evaluated beyond 1 year," said Amit Saxena, MD in an interview. Therefore, Dr Amit and his team conducted a controlled extension study, AURORA 2. They recently reported the first interim analysis of the ongoing AURORA 2 study.
In this two years, blinded controlled extension study, the researchers included patients who completed the AURORA 1study. They enrolled 116 patients in the voclosporin arm and 100 patients in the control arm enrolled in the extension study, of which 73 patients in the voclosporin arm and 51 patients in the control arm had received two years of treatment. The patients received either voclosporin (23.7 mg BID) or placebo, in combination with MMF (1 g BID) and low-dose oral steroids according to the randomization schedule. The researchers evaluated the urine protein creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR) in patients with up to two years of total treatment: one year from AURORA 1 and up to one year in AURORA 2.
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