Abstract
BackgroundThe aim of the present study was to evaluate the association between the histology of active and chronic lesions and urinary protein and serum creatinine (SCr) levels, as common clinical endpoints in clinical trials for lupus nephritis (LN).MethodsIn total, 119 patients diagnosed with LN class III, IV, and V, as defined by the International Society of Nephrology/Renal Pathology Society, between 1990 and 2015, were enrolled in the present study. Multiple regression analysis was performed to explore semi-quantitative histological variables associated with urinary protein and SCr levels.ResultsThe mean age of the enrolled patients was 45 years, and 79% were female. The mean SCr and mean urinary protein levels at the time of renal biopsy were 0.87 mg/dl and 3.00 g/gCr, respectively. Class IV (71%) was the most common type of LN followed by class III (17%), and class V (13%). Multicollinearity was confirmed between monocellular infiltration (variance inflation factor [VIF] = 10.22) and interstitial fibrosis (VIF = 10.29), and between karyorrhexis (VIF = 4.14) and fibrinoid necrosis (VIF = 4.29). Fibrinoid necrosis and monocellular infiltration were subsequently excluded, and multiple regression analysis revealed that only the urinary protein level was correlated with wire loop lesions (β-coefficient [β]: 1.09 and confidence interval [CI]: 0.35 to 1.83), and that the SCr level was correlated with glomerular sclerosis (β: 1.08 and CI: 0.43 to 1.74).ConclusionAs urinary protein and SCr levels were not quantitatively associated with active lesions, they may not accurately reflect the response to remission induction therapy in patients with LN.
Highlights
The aim of the present study was to evaluate the association between the histology of active and chronic lesions and urinary protein and serum creatinine (SCr) levels, as common clinical endpoints in clinical trials for lupus nephritis (LN)
Patient characteristics at renal biopsy From a total of 158 patients with LN, 119 patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III, IV, and/or V were enrolled in the present study after eliminating 11 patients with class I, II, or VI; 20 patients with a lack of clinical data; and eight patients who underwent a re-biopsy
In this study, we explored the associations between histological findings and urinary protein and SCr levels at renal biopsy
Summary
The aim of the present study was to evaluate the association between the histology of active and chronic lesions and urinary protein and serum creatinine (SCr) levels, as common clinical endpoints in clinical trials for lupus nephritis (LN). While clinical trials for promising therapeutic agents for lupus nephritis (LN), such as B cell targeted therapy, cytokine-targeted therapy (IL-6 and IFN-a), and cytotoxic T lymphocyte-associated antigen 4, have been conducted, none have shown improved outcomes compared with controls [1]. These failures may be attributed to inadequate inclusion criteria, study populations, sample sizes, and study duration [1, 2]. Proteinuria and the SCr level at renal biopsy may reflect chronic but not active lesions, which may respond to immunosuppressive treatment, and may serve as prognostic predictors for LN
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