ORLANDO, Fla. —The investigational calcineurin inhibitor voclosporin (VCS) helped lupus nephritis patients achieve quicker remission, when used with the current standard of care, researchers reported at the 2017 National Kidney Foundation Spring Clinical Meetings. Voclosporin is an experimental immunosuppressant drug being developed by Aurinia Pharmaceuticals.
The AURA study was a randomized trial enrolling 265 patients with class 3/4/5 lupus nephritis in over 20 countries, and compared the safety and efficacy of low (23.7) or high-dose (39.5) VCS in addition to MMF 2g/day and steroids with class 3/4/5 lupus nephritis.
“The most exciting aspect of this data is that voclosporin is the first treatment candidate to successfully meet all of its clinical endpoints in a global, prospective LN trial” said Dr. Samir Parikh, a clinical investigator for the study and Assistant Professor, Clinical Nephrology at the Ohio State University.
“Voclosporin, when added to standard of care, achieved the highest complete remission rate of any global, active LN trial, and this was accomplished with extremely low-dose steroid exposure. The possibility of achieving a better clinical response while avoiding the significant side effects associated with prolonged exposure to high dose steroids has the potential to be a game-changer in the management of LN.”
Each arm of the study included the current standard of care of mycophenolate mofetil (MMF) as background therapy and a forced steroid taper. Both doses of voclosporin at 48 weeks demonstrated continued improvement over the control group across multiple dimensions.
In addition to the trial meeting its complete remission (CR) and partial remission (PR) endpoints at 48 weeks, all pre-specified secondary endpoints that have been analyzed to date were also met at 48 weeks, including reduction in Systemic Lupus Erythematosus Disease Activity Index or SLEDAI score and reduction in urine protein creatinine ratio (UPCR).
No unexpected safety signals were observed and voclosporin was generally well-tolerated, with the nature of adverse events consistent with what is expected of patients suffering from highly active lupus nephritis while undergoing immunomodulation-based therapy, the study authors said.
In the voclosporin arms, the renal function as measured by eGFR was stable and not significantly different from the control arm during the 48-week treatment period. Mean blood pressure was also similar between all treatment groups.