December 4, 2019
The Lupus Research Alliance congratulates Aurinia Pharmaceuticals on achieving the first positive Phase III trial results for an urgently needed treatment for lupus nephritis. The company’s investigational drug voclosporin showed positive effectiveness and good safety for treating lupus nephritis in combination with standard therapy.
“Lupus nephritis is one of the most common and dangerous complications of lupus,” commented Kenneth M. Farber, President and CEO of the Lupus Research Alliance. “These positive results suggest that voclosporin plus standard of care may provide the first safe and effective treatment option for the many people with lupus nephritis. It is especially gratifying to see the robust patient participation in this trial as involving the community in clinical research has long been a focus of the LRA and our affiliate Lupus Therapeutics, the only organization focused solely on conducting lupus clinical trials throughout North America.”
Aurinia’s AURORA Phase III clinical trial met its primary endpoint, with 40.8% of patients treated with voclosporin plus standard therapy achieving complete renal response at 52 weeks compared with 22.5 percent of those who received placebo plus standard of therapy. Secondary endpoints showing effectiveness in achieving partial renal response were also significantly better among patients treated with voclosporin than those who received placebo. Voclosporin was also well-tolerated; 20.8 percent of those who received the drug reported serious adverse events versus 21.3 percent of those given placebo. The global, double-blind, placebo-controlled study enrolled 357 patients with active lupus nephritis.
When the kidneys become inflamed (nephritis), they can’t effectively get rid of waste products and other toxins from the body. While there is usually no pain associated with nephritis, some patients may notice dark urine and swelling around their eyes, legs, ankles, or fingers. Typically, an abnormal urine or blood test is the only indication of kidney disease. But because the kidneys are so important to overall health, lupus patients with kidney disease generally require intensive treatment to help prevent permanent damage.
Lupus Therapeutics is currently working on two clinical trials in lupus nephritis – the PAISLEY study testing the safety and effectiveness of BMS-986165 as a potential treatment and the DIVINE study which recently reported preliminary results towards the goal of utilizing multiple imaging techniques to enable non-invasive monitoring of kidney function. The Lupus Research Alliance is also working to address the diagnosis and management of lupus nephritis through our collaboration with the National Kidney Foundation on the recently released Continuing Medical Education program for healthcare providers. In addition, the LRA worked with Equillium to ensure the patient perspective is well-represented in the trial design and initiation of their Equalise trial testing itolizumab in lupus nephritis.
The Lupus Research Alliance has invested significantly in fundamental research aimed at understanding lupus nephritis and identifying potential pathways to target in drug development.