Lupus Nephritis Patients Should be Excited About the Results of This Phase 3 Trial

According to a story from BioPortfolio, the biopharmaceutical company Aurinia Pharmaceuticals, Inc. has recently announced positive findings from its phase 3 clinical trial of the experimental drug voclosporin, which was used in combination with low-dose steroids and mycophenolate as a treatment for lupus nephritis. The study demonstrated that the addition of voclosporin displayed decisive advantages over the current standard treatment for the condition.

About Lupus Nephritis

Lupus nephritis is a medical complication characterized by kidney inflammation which can appear as a result of systemic lupus erythematosus, more commonly known as lupus. In effect it is a form of glomerulonephritis, but this form is linked specifically to lupus and has notable differences in outcomes and presentation. Lupus nephritis is an autoimmune disease in which the body’s own immune system mistakenly attacks healthy tissue. The cause of lupus and lupus nephritis is not well understood, with a variety of genetic and environmental factors possibly playing a role. Symptoms of the disease include swelling, fever, foamy urine, joint pain, high blood pressure, muscle pain, and the characteristic butterfly rash that also appears with systemic lupus. Treatment usually involves the use of immune system suppressing drugs such as corticosteroids, but when the disease progresses to kidney failure, kidney transplant is the best option. To learn more about lupus nephritis, click here.

About The Trial

The trial included a total of 357 patients with active disease. When compared to mycophenolate and steroid treatment alone, the addition of voclosporin was able to produce a Renal Response rate of 40.8 percent versus just 22.5 percent. The voclosporin combination also demonstrated superiority in all secondary endpoints, such as urinary protein to creatinine ratio,  time for reduction in urinary protein to creatinine ratio by 50 percent, Renal Response by 24 weeks, and Partial Renal Response by 24 weeks and 52 weeks.

20.8 percent of patients treated with the combination reported serious adverse events, which was slightly less than the control treatment (21.3 percent). Infection was the most common adverse event. Six patients died during the study with five of these being in the control group.

These results clearly indicate that voclosporin has the potential to improve treatment outcomes for lupus nephritis. The drug was previously granted Fast Track designation by the FDA.

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