Phase 3 results from the AURORA study demonstrated combining voclosporin with mycophenolate and low-dose corticosteroids was superior to standard care for treating patients with lupus nephritis. The results were made available through a press release from Aurinia Pharmaceuticals.
“The treatment of lupus nephritis has been extremely challenging to date, and people with lupus are in need of innovative treatments for this serious disease,” Stevan W. Gibson, president and CEO of the Lupus Foundation of America, said in the release. “We’re proud to have been part of this important achievement through our work educating people with lupus nephritis about the trial and the importance of clinical trial participation. Voclosporin is the first novel treatment that has demonstrated therapeutic efficacy for people living with lupus nephritis and today marks an important advance in the treatment of this potentially life-threatening disease.”
According to the release, the study included 357 patients with active lupus nephritis. Of the study population, 40.8% of participants taking voclosporin had renal response at 52 weeks vs. 22.5% of those in the control group, causing the study to meet its primary endpoint. In addition, patients taking voclosporin achieved a 50% reduction in urinary protein-to-creatinine ratio faster than the control.
Regarding safety, researchers found 20.8% of patients in the voclosporin group reported serious adverse events vs. 21.3% in control (infection being most common). One mortality was observed in the voclosporin group vs. five in control.
“We are thrilled with the outcomes reported today from the AURORA trial, which unequivocally demonstrate the tremendous potential for voclosporin to play an important role in the treatment of the approximately one million people worldwide living with lupus nephritis,” Peter Greenleaf, president and CEO of Aurinia, said. “We are aware of the intense need for a clinically impactful therapy for this serious disease and are working with urgency to complete regulatory filings in the U.S. and worldwide. If approved, we look forward to potentially making voclosporin available to patients beginning in 2021.”