Voclosporin improves the likelihood of complete renal response in patients with lupus nephritis (LN) of any biopsy class, investigators reported in a poster presentation at the virtual 2021 National Kidney Foundation Spring Clinical meetings.
A team led by Anca Askanase, MD, MPH, of the Columbia University Lupus Center in New York City, pooled data from the phase 2 AURA-LV and the phase 3 AURORA trials that evaluated treatment with mycophenolate mofetil (MMF) and low-dose steroids with and without the addition of voclosporin, a novel calcineurin inhibitor. The intent-to-treat population included 268 patients in the voclosporin (23.7 mg BID) group and 266 patients in the control group.
The primary endpoint of complete renal response (CRR) was defined as a urine protein to creatinine ratio (UPCR) of 0.5 mg/mg or less, stable renal function (an estimated glomerular filtration rate [eGFR] of 60 mL/min/1.73 m2 or more or no eGFR decrease greater than 20%), sustained use of low-dose steroids, and no use of rescue medication.
Overall, voclosporin use was significantly associated with 2.8-fold increased odds of CRR at 1 year compared with the control group. This treatment benefit extended across all LN biopsy classes, Dr Askanase’s team reported. In pure class 3 and 4 proliferative LN, voclosporin correlated with significant 4.3- and 2.6-fold increased odds of CRR. In mixed class 3 or 4 (with or without class 5), voclosporin correlated with significant 2.7-fold increased odds of CRR. In pure class 5 membranous LN, voclosporin correlated with nonsignificant 1.5-fold increased odds of CRR.
The vast majority (93.7%) of patients receiving add-on voclosporin achieved a 50% or more reduction in UPCR compared with 75.2% of patients receiving MMF and low-dose steroids only. The voclosporin arm achieved this endpoint at 29 days compared with 58 days in the control arm.
Mean eGFR remained at or above 60 mL/min/1.73 m2 in both groups. After a dip in eGFR of -3.4 mL/min/1.73 m2 at week 4 in the voclosporin group, mean eGFR stabilized to -1.0 mL/min/1.73 m2 at 1 year in these patients.
Serious adverse events (22.8% vs 18.8%) and serious infection-related events (10.1% vs 10.2%) occurred in comparable proportions of the voclosporin and control group, respectively.
“Adult patients with lupus nephritis treated with oral voclosporin in combination with MMF and low-dose steroids achieved meaningful reductions in proteinuria and achieve that reduction faster compared to patients treated with MMF and low-dose steroids alone,” Dr Askanase’s team concluded.
Disclosure: This clinical trial was supported by Aurinia Pharmaceuticals. Please see the original reference for a full list of authors’ disclosures.
Askanase A, Randhawa S, Lisk L, Mina-Osorio P. Efficacy of voclosporin across lupus nephritis biopsy classes: Pooled data from the AURORA and AURA-LV trials. Presented at the virtual National Kidney Foundation 2021 Spring Clinical Meetings, April 6-10, 2021. Poster 283.