Radin M, Miraglia P, Barinotti A, Fenoglio R, Roccatello D, Sciascia S: Prognostic and Diagnostic Values of Novel Serum and Urine Biomarkers in Lupus Nephritis: A Systematic Review. American Journal of Nephrology DOI 10.1159/000517852
The role and value of novel serum and/or urinary biomarkers in the diagnosis and prognosis evaluation of lupus nephritis continues to be highly uncertain.
This is largely due to the paucity of randomized clinical trials and/or the lack of comparison with standard clinically recommended parameters. An extensive literature has accumulated (mainly observational and retrospective) concerning the utility of such novel biomarkers. Only a few have shown much promise, but none have yet been validated in a prospective controlled clinical trial.
In a systematic review of the published data (between 2015 and 2020), involving 8,872 patients with lupus nephritis, Radin et al. attempted to evaluate the current status of novel urinary and/or serum biomarkers in lupus nephritis. They excluded from consideration those biomarkers (like serum creatinine, proteinuria, anti-nuclear antibodies, or serum complement assays) that have already been incorporated into guideline recommendations.
This analysis, not unexpectedly, revealed a great deal of heterogeneity in subject enrollment and in analytic approaches. No randomized clinical trials were included. A few novel biomarkers showed some promise (MCP-1, VCAM-1, urinary adiponectin, KIM-1). Inconsistencies in the utility of many of the studied biomarkers rendered their value suspect. The role of assays for factors acting on B-cells was limited and uncertain.
This field is rather stagnant, and much work needs to be done before any novel biomarker can be elevated to routine clinical use as standard-of-care. In my opinion, none can yet be used to augment a precision-medicine approach to lupus nephritis. The conclusions of the authors of this detailed systematic review support this viewpoint.