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 - Seite 2

These results were achieved with most patients in both groups (>75%) maintaining glucocorticoid tapering throughout the study and receiving doses of ≤2.5 mg/day at the end of the extension study.

Of those who experienced adverse events (AEs) in the extension study, most were mild or moderate (86% in the voclosporin group vs. 81% in the control group). Across three years of treatment, infections were the most common type of AE (69.8% in the voclosporin group vs. 72.0% in the control group), with low rates of serious infections in both groups (12.9% in the voclosporin group vs. 17.0% in the control group). Most adverse events declined annually over the study period, with 86.1% of patients completing the two-year extension.

“The results of this extension study reinforce the long-term safety and effectiveness of LUPKYNIS to stabilize kidney function in those diagnosed with LN, a debilitating, yet common complication that occurs in about half of people with lupus,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia. “Together, AURA-LV, AURORA 1, and AURORA 2 represent one of the largest and longest placebo-controlled clinical programs evaluating the treatment of LN. We are proud of our sustained research in autoimmune diseases like lupus and remain committed to helping improve kidney health for people living with lupus nephritis.”

About the AURORA Clinical Program
In AURORA 1 (NCT03021499), a 12-month, phase 3, double-blind, randomized-controlled pivotal study, the efficacy and safety of voclosporin was compared with a control group in achieving CRR in patients with LN. AURORA 1 demonstrated the clinical superiority of voclosporin with mycophenolate mofetil (MMF) and low-dose glucocorticoids compared to MMF and low-dose glucocorticoids alone. Significantly more patients in the voclosporin group achieved a CRR at 52 weeks of treatment and did so significantly faster than those in the control group. The safety profile in AURORA 1 was comparable between treatment groups, in line with previous studies; no new safety concerns were observed. Results from the completed Phase 3 randomized, double-blind, placebo-controlled, multicenter AURORA 1 study were published in The Lancet.