Voclosporin Found to Improve Renal Outcomes in Lupus Nephritis – Renal and Urology News

Addingvoclosporin (VCS) to standard of care improves renal outcomes in patients withactive lupus nephritis (LN), according to findings from the AURORA studypresented at the live virtual 2020 National Kidney Foundation Spring ClinicalMeetings.

Basedon the findings, Aurinia Pharmaceuticals, the company developing the drug,plans to file an application seeking FDA approval.

Weare pleased to report that the patients who received voclosporin were 2.65times more likely to meet the criteria for response based on proteinuria andeGFR [estimated glomerular filtration rate], lead investigator Keisha L.Gibson, MD, MPH, Associate Professor of Medicine and Pediatrics and Chief ofPediatric Nephrology at the University of North Carolina School of Medicine inChapel Hill, said in an NKF press statement. There were no differences in thesafety profile between the voclosporin and standard care groups.

DrGibson added, We know that achieving remission status in lupus kidney diseasecorrelates with good long-term kidney survival and so the results of this studyare very encouraging.

TheAURORA study is a global, double-blind, placebo-controlled phase 3 trial thatenrolled 357 patients with active LN. Investigators randomly assigned patientsto receive voclosporin or placebo in combination with mycophenolate (MMF) andlow-dose steroids. The primary end point was renalresponse (RR) at 52 weeks. They defined RR as a urine protein to creatinineratio (UPCR) of 0.5 mg/mg or less, eGFR of 60 mL/min/1.73 m2 orhigher, or no confirmed 20% or greater decrease in eGFR from baseline, thepresence of sustained, low-dose steroids, and no administration of rescuemedication.

TheRR at 52 weeks was 40.8% for the voclosporin recipients compared with 22.5% forthe control arm, a statistically significant difference between the groups, DrGibson and her collaborators reported in a late-breaking abstract session. Thevoclosporin group achieved low protein levels twice as quickly as patientsreceiving standard of care. An analysis of the median time to a UPCR less than0.5 mg/mg showed a significant and clinically meaningful benefit in thevoclosporin arm compared with the standard of care arm (169 vs 372 days).

Voclosporinwas well tolerated, with no unexpected safety issues, according to theinvestigators. Serious adverse events ere in 20.8% of the voclosporinrecipients and 21.3% of control arm. The most common reported SAE wasinfection, which developed in 10.1% and 11.2% of the voclosporin and controlsgroups, respectively.

Read more of our coverage of the National Kidney Foundations virtual 2020 Spring Clinical Meetings by visiting the conference page.

Reference

Gibson K, Parikh S, Sexena A, et al. AURORA phase 3 trial demonstrates voclosporin statistical superiority over standard of care in lupus nephritis (LN). Data presented at the National Kidney Foundations virtual 2020 Spring Clinical Meetings held March 25 to 29. ePoster 407.

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Voclosporin Found to Improve Renal Outcomes in Lupus Nephritis - Renal and Urology News

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