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More than 40% of the treatment arm of the placebo-controlled trial achieved a complete renal response.
New research shows a combination treatment regimen that includes voclosporin results in clinical benefits for lupus nephritis patients.
A team, led by Brad H. Rovin, MD, Department of Nephrology, The Ohio State University Wexner Medical Center, evaluated the efficacy and safety of voclosporin for patients with lupus nephritis.
Voclosporin is a novel calcineurin inhibitor currently approved by the US Food and Drug Administration for the treatment of adults with lupus nephritis. In phase 2 data, the drug has resulted in improved complete renal response rates in this patient population.
In the multicenter, double-blind, randomized, phase 3 trial, the researchers examined patients with systemic lupus e4rthematous with lupus nephritis in 142 hospitals and clinics across 27 countries. The disease was diagnosed in accordance using the American College of Rheumatology criteria and a kidney biopsy within 2 years that showed class III, IV, or V (alone or in combination with class III or IV).
Each patient was randomly assigned to either 23.7 mg twice daily of oral voclosporin (n = 179) or placebo (n = 178), on a background of mycophenolate mofetil 1 g twice daily and rapidly tapered low-dose oral steroids, by use of an interactive web response system.
The investigators sought primary endpoints of complete renal response at 52 weeks defined as a composite of urine protein creatinine ration of 0.5 mg/mg or less, stable renal function, defined as estimated glomerular filtration rate [eGFR] ≥60 mL/min/1·73 m2 or no confirmed decrease from baseline in eGFR of >20%, no administration of rescue medication, and no more than 10 mg prednisone equivalent per day for 3 or more consecutive days or for 7 or more days during weeks 44-52, just prior to the primary endpoint assessment.
More patients in the treatment arm achieved complete renal response at week 52 in comparison with the placebo group (n = 73; 41%; vs. n = 40; 23%; OR, 2.65; 95% CI, 1.64-4.27; P <0.0001).
Adverse event rates were similar between the 2 groups, with serious adverse events occurring in 21% (n = 37) of the voclosporin group and 21% (n = 38) in the placebo group.
The most frequent serious adverse event was pneumonia, which occurred in 4% (n = 7) in the treatment group and 4% (n = 8) of the placebo group. In addition, 6 patients died during the study or study follow-up period, 5 of which were in the placebo group and the remaining death in the treatment group was not considered related to voclosporin.
“Voclosporin in combination with MMF and low-dose steroids led to a clinically and statistically superior complete renal response rate versus MMF and low-dose steroids alone, with a comparable safety profile,” the authors wrote. “This finding is an important advancement in the treatment of patients with active lupus nephritis.”
The study, “Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomized, multicenter, placebo-controlled, phase 3 trial,” was published online in The Lancet.