Adding voclosporin to MMF and steroids results in long-term higher CRR in severe lupus nephritis

The addition of voclosporin to mycophenolate mofetil (MMF) and low-dose steroids in patients with severe lupus nephritis leads to significantly higher complete renal response (CRR) rates compared to patients treated with MMF and low-dose steroids alone, over a 3-year follow-up period. Estimated glomerular filtration rate and serum creatinine remained stable over time and similar safety outcomes were reported in both treatment arms [1].

Voclosporin is a novel, structurally modified calcineurin inhibitor which has a dual mechanism of action, acting as an immunosuppressant through inhibition of T cell activation and cytokine production and promoting podocyte stability in the kidney. The AURORA 1 study (NCT03021499) reported that adding voclosporin to MMF and low-dose steroids increased rates of CRR at 52 weeks significantly in patients with lupus nephritis (a severe and frequent complication of systemic lupus erythematosus). The efficacy of the treatment regimen was maintained for an additional 24 months in patients who continued treatment in the AURORA 2 study (NCT03597464). Dr Hanni Menn-Josephy (Boston University School of Medicine, USA) presented a post hoc analysis of the use of voclosporin in patients with severe lupus nephritis using pooled data from the AURORA 1 and AURORA 2 studies. Patients who were treated with voclosporin or placebo in AURORA 1 and who completed the study continued the same treatment in AURORA 2 for an additional 2 years (voclosporin, n=116; placebo, n=100). “The treatment benefit of voclosporin was observed in patients with severe disease across the 3-year treatment period,” said Dr Menn-Josephy. “At month 36, 53.2% of patients had a CRR versus 35.1% of those on placebo (OR 2.92; 95% CI 1.07–7.94; P=0.036). Mean corrected estimated glomerular filtration rate and mean serum creatinine levels were stable throughout the study including at the follow-up visit at 4 weeks after treatment discontinuation.” Adverse-event rates in patients with severe disease were comparable between arms, with infections being most common.

1. Menn-Josephy H, et al. Efficacy and Safety of Voclosporin Over 3 Years in Patients With Severe Lupus Nephritis. FR-OR58, ASN Kidney Week 2022, 3–6 Nov.

 

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Posted on 8 December 20228 December 2022