Voclosporin and the Antiviral Effect Against SARS-CoV-2 in Immunocompromised Kidney Patients

Arends, Eline J.; Meziyerh, Soufian; Moes, Dirk Jan A.R.; Kamerling, Sylvia W.A.; van der Kooy, Sandra; Ogando, Natacha S.; Snijder, Eric J.; van Hemert, Martijn; Visser, Leo G.; Feltkamp, Mariet C.W.; Claas, Eric C.J.; Rabelink, Ton J.; van Kooten, Cees; de Vries, Aiko P.J.; Teng, Y.K. Onno

doi:10.1016/j.ekir.2023.09.003

Cited by 1 publication

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References 32 publications

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“…Preclinical work demonstrates that voclosporin inhibits SARs‐CoV‐2 replication, with clinical research in this area recently reported (24, 25). Interestingly, three deaths due to coronavirus infection occurred in the control group during AURORA 2 and none in the voclosporin group.…”

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Long‐Term Voclosporin Treatment for Lupus Nephritis in the Phase 3 AURORA 2 Clinical Trial

Saxena

Ginzler

Gibson³

et al. 2023

Arthritis & Rheumatology

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ObjectiveAURORA 2 evaluated the long‐term safety, tolerability, and efficacy of voclosporin compared to placebo in patients with lupus nephritis (LN) receiving an additional two years of treatment following completion of the one‐year AURORA 1 study.MethodsEnrolled patients continued their double‐blinded treatment of voclosporin or placebo randomly assigned in AURORA 1, in combination with mycophenolate mofetil and low‐dose glucocorticoids. The primary objective was safety assessed with adverse events (AEs), biochemical and hematological assessments. Efficacy was measured by renal response.Results216 patients enrolled in AURORA 2. Treatment was well tolerated with 86.1% completing the study and no unexpected safety signals. Adverse events occurred in 86% and 80% of patients in the voclosporin and control groups, respectively, with an AE profile similar to that seen in AURORA 1, albeit with reduced frequency. Investigator reported AEs of both GFR decrease and hypertension occurred more frequently in the voclosporin than control group (10.3% vs 5.0%, and 8.6% vs 7.0%, respectively). Mean corrected estimated glomerular filtration rate (eGFR) was within the normal range and stable in both treatment groups. eGFR slope over the two‐year period was ‐0.2 ml/min/1.73 m2 (95% CI ‐3.0, 2.7) in the voclosporin and ‐5.4 ml/min/1.73 m2 (95% CI ‐8.4, ‐2.3) in the control group. Improved proteinuria persisted across three years of treatment leading to more frequent complete renal responses in voclosporin‐treated patients (50.9% vs 39.0%; odds ratio 1.74; 95% CI 1.00, 3.03).ConclusionData demonstrate the safety and efficacy of long‐term voclosporin treatment over 3 years of follow‐up in patients with LN.image

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Section: Discussionmentioning

confidence: 99%