Aurinia Pharmaceuticals presents voclosporin remission data at EULAR
Aurinia Pharmaceuticals presented new duration of remission data from its global Phase IIB AURA-LV study in lupus nephritis during the Annual European Congress of Rheumatology 2017 in Madrid, Spain. As previously reported, treatment with low dose voclosporin showed statistically improved efficacy over the control arm at both 24 and 48 weeks, with a doubling of remission rates at 48 weeks versus the control arm. These results were achieved in the presence of low doses of corticosteroids and normal, stable renal function. Furthermore, of the low-dose voclosporin patients that achieved CR at 24 weeks, 100% remained in CR at 48 weeks, establishing durability of clinical response. The data presented at EULAR 2017 demonstrated that over the course of the 48-week trial, patients on voclosporin stayed in remission approximately twice the amount of time as those in the control group. These differences were statistically significant versus the control arm. Duration of remission as measured by proteinuria is clinically meaningful as it may correlate with lower rates of progression to Chronic Kidney Disease. All arms of the study included the current standard of care of mycophenolate mofetil as background therapy and an aggressive steroid taper. Both doses of voclosporin at 48 weeks demonstrated continued improvement over the control group across multiple measures. The voclosporin treated groups demonstrated statistically significant improvement over the control group in speed and rates of complete and partial remission. Proteinuria levels and reduction in Systemic Lupus Erythematosus Disease Activity Index scores, which include non-renal measures of lupus activity, also continued to significantly improve over time versus the control group. Additional analyses are ongoing and will be presented at future medical and scientific meetings. No unexpected safety signals nor adverse events were observed and voclosporin was generally well-tolerated, consistent with what is expected of patients suffering from active LN while undergoing immunomodulation-based therapy. In the voclosporin arms, renal function as measured by estimated glomerular filtration rate was stable and not significantly different from the control arm following the 48-week treatment period. There were no electrolyte changes in the treatment groups and mean blood pressure was also similar across treatment groups through 48 weeks.