Aurinia says long term Lupkynis data published in Arthritis & Rheumatology

Aurinia Pharmaceuticals announced that full results from the Phase 3, double-blind, placebo-controlled AURORA 2 extension study were published online in Arthritis & Rheumatology, the official peer-reviewed journal of the American College of Rheumatology. As part of the AURORA Clinical Program, the AURORA 2 extension study assessed the long-term safety and tolerability of LUPKYNIS, compared with placebo, in combination with mycophenolate mofetil and low-dose glucocorticoids, to treat active lupus nephritis in adult patients who completed one year of treatment in the Phase 3 AURORA 1 clinical trial. Voclosporin was well tolerated with no new or worsening safety signals in the extension study. Clinical efficacy over three years of treatment was maintained, as observed by maintenance of urine protein creatinine ratio reductions, sustained complete renal response and preserved kidney function, suggesting a positive benefit-risk profile for voclosporin in LN patients. “Proteinuria, a defining part of the characterization of chronic kidney disease, often precedes a decline in kidney function and is associated with progression to kidney failure. Reductions in proteinuria are critical for slowing or stopping progression to end-stage kidney disease and improving long-term outcomes for LN patients. Notably, in this extension study, kidney preservation, sustained renal response, and reductions in steroid use were achieved with voclosporin. These findings demonstrate the critical importance of voclosporin in the management of LN to improve patient outcomes,” said lead study author Amit Saxena, MD, Division of Rheumatology, New York University Grossman School of Medicine.