Pooled analyses of data from 2 clinical trials provide additional support for the safety and efficacy of voclosporin (VCS), a novel calcineurin inhibitor, in the treatment of lupus nephritis (LN), according to a presentation at the American Society of Nephrology’s Kidney Week 2020 Reimagined virtual conference.
Brad H. Rovin, MD, of Ohio State University Wexner Medical Center in Columbus, Ohio, and colleagues analyzed combined data from the phase 2 AURA-LV and phase 3 AURORA clinical trials. Both trials demonstrated that VCS increased renal response significantly compared with mycophenolate mofetil. The investigators defined renal response as a urine protein-to-creatinine ratio of 0.5 mg/mg or less, an estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73 m2 or higher or no decline more than 20% from baseline, need for 10 mg prednisone or less 8 weeks prior to endpoint measurements, and no need for rescue medications. The integrated dataset included an intent-to-treat population of 268 patients treated with VCS at a dosage of 23.7 mg twice daily and 266 control patients.
The renal response at 1 year was 43.7% for the VCS arm compared with 23.3% for controls, Dr Rovin’s team reported. VCS treatment was significantly associated with approximately 2.8-fold increased odds of renal response compared with controls. The 1-year renal response for Hispanic patients—a high-risk LN patient population—was 37.9% for VCS recipients compared with 19.4% for controls.
The largest change in eGFR from baseline for VCS recipients compared with controls occurred early, declining by 5.6 mL/min/1.73 m2 by week 4. By week 52, the change in eGFR improved, declining by 3.7 mL/min/1.73 m2 compared with controls. The mean change from baseline of eGFR in the VCS arm at week 52 was -1.0 mL/min/1.73 m2, which was not statistically significant.
The proportion of patients who experienced serious adverse events was similar between the VCS and controls groups (22.8% vs 18.8%).
Disclosure: Aurinia Pharmaceuticals Inc., which is developing voclosporin, sponsored the study.
Rovin BH, Parikh SV, Huizinga RB, et al. Management of lupus nephritis (LN) with voclosporin: An update from a pooled analysis of 534 patients. Presented at: Kidney Week 2020 Reimagined virtual conference, October 19 to 25. Poster PO1917.