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Long Term Phase 3 Data Published in Arthritis & Rheumatology Shows LUPKYNIS® (voclosporin) Preserved Kidney Function Up to Three Years in Lupus Nephritis Patients with No New or Unexpected Adverse Events
EDMONTON, Alberta--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that full results from the Phase 3,
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":" EDMONTON, Alberta--(BUSINESS WIRE)--\nAurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today 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.\n\n\nAs part of the AURORA Clinical Program, the AURORA 2 extension study assessed the long-term safety and tolerability of LUPKYNIS® (voclosporin), compared with placebo, in combination with mycophenolate mofetil and low-dose glucocorticoids, to treat active lupus nephritis (LN) in adult patients who completed one year of treatment in the Phase 3 AURORA 1 clinical trial.\n\n\nVoclosporin 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 (UPCR) reductions, sustained complete renal response (CRR) and preserved kidney function, suggesting a positive benefit-risk profile for voclosporin in LN patients.\n\n\n“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.\n\n\nEstimated glomerular filtration rate (eGFR), an important measurement of kidney function, remained stable throughout the extension study. The slope of the change in eGFR over the extension study period at month 36 demonstrated kidney function preservation in the voclosporin group (-0.2 mL/min/1.73m2), compared with a decline in function after one year in the control group (-5.4 mL/min/1.73m2).\n\n\nThere was a significant increase in achievement of CRR in LN patients treated with voclosporin, compared to patients in the control group,...