Voclosporin, a novel calcineurin inhibitor, can achieve complete renal response (CRR) in patients with severe lupus nephritis (LN), investigators reported at the American Society of Nephrology’s Kidney Week 2021.

Their post-hoc analysis of the phase 3 AURORA 1 trial found that the efficacy of voclosporin in severe LN is similar to that of the overall study population.

In the trial, 179 patients were randomly assigned to voclosporin (23.7 mg twice daily) and 178 patients to placebo, in addition to background therapy including mycophenolate mofetil (MMF; 1 g twice daily) and low-dose oral steroids. Compared with other calcineurin inhibitors, voclosporin has an improved lipid and glucose profile and no drug-drug interaction with MMF.

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Severe LN, defined as baseline urinary protein to creatinine ratio (UPCR) of 3 mg/mg or greater, occurred in 76 patients in the voclosporin group and 72 patients in the control group. Mean UPCR at baseline was 5.9 mg/mg.

For the post hoc analysis, 50 patients with pure class 5 LN were excluded.

The primary outcome of CRR at 52 weeks among patients with severe disease occurred in 34.2% of voclosporin-treated patients and 11.1% of control patients, Hanni Menn-Josephy, MD, of Boston University School of Medicine in Massachusetts, reported for her team during an oral presentation. Voclosporin use among patients with severe disease was significantly associated with 4.4-fold increased odds of CRR, defined as a UPCR of 0.5 mg/mg or less with stable renal function, low-dose steroids, and no use of rescue medication. Rates of adverse events and serious adverse events were similar between groups. 

Voclosporin was not significantly associated with improved CRR among patients with non-severe disease.

Voclosporin has 2 mechanisms of action, she explained. Inhibition of calcineurin reduces activation of T cells and also stabilizes podocytes to reduce proteinuria.

“Patients with severe lupus nephritis treated with voclosporin in combination with MMF and low-dose steroids had clinically meaningful reductions in proteinuria and achieved significantly higher rates of complete renal response compared to patients with MMF and low-dose steroids alone,” Dr Menn-Josephy concluded.

This research was supported by Aurinia Pharmaceuticals Inc. Please see the original reference for a full list of disclosures.


Menn-Josephy H; Truman M, Palmen M, Mina-Osorio P. Voclosporin is effective in achieving complete renal response in severe lupus nephritis. Presented at: Kidney Week 2021, November 2-7, 2021. Presentation: SA-OR31.