Voclosporin Efficacy and Safety in Lupus Nephritis Save
An integrated analysis of two pivotal trials of voclosporin, a calcineurin inhibitor, in lupus nephritis patients saw significant improvement in complete renal responses (CRR) at one year.
at 23.7 mg twice daily in combination with mycophenolate mofetil (MMF) and oral glucocorticoids in lupus nephritis (LN) using pooled data from two large phase 2 and phase 3 clinical trials. The purpose was to expand the pool of patients for safety analyses and to increase power for efficacy analyses in patient subpopulations.
AURA-LV (phase 2) and AURORA 1 (phase 3) were randomized, placebo-controlled, double-blind trials that enrolled 534 lupus nephritis (LN) patients (voclosporin 268, control 266) who were randomized to either voclosporin (23.7 mg twice daily with mycophenolate mofetil (MMF) and oral glucocorticoids) or placebo (plus MMF and glucocorticoids). The primary endpoint was the complete renal response (CRR) at approximately 1 year.
Thos on voclosporin achieved significantly more CRR at 1 than control group (43.7% vs. 23.3%, OR 2.76; 95% CI 1.88, 4.05 p<0.0001).
Adverse events (AEs) was similar between groups (91.4% voclosporin and 87.2% control) and most were mild to moderate in severity. Most common AEs were infections (62.2% voclosporin, 54.9% control) and gastrointestinal disorders (45.3% voclosporin, 35.3% placebo).
This integrated analysis demonstrates the efficacy and safety of voclosporin in the treatment of LN across the diverse racial and ethnic groups studied.