Abstract
This study aims to elucidate the predictive capabilities of proteinuria, serum creatinine (Cr), and urine RBCs (uRBCs) with respect to long-term renal outcomes in lupus nephritis (LN) in patients followed in clinic. Methods. A retrospective analysis was performed on patients with LN. We evaluated the ability of proteinuria, serum Cr, and uRBCs at 12 months to predict good long-term renal outcomes defined as serum Cr ≤ 100 mmol/L and kidney transplant/dialysis-free at the 7th year. Receiver operator characteristic curves were generated for proteinuria, serum Cr, and uRBCs to study their ability to predict good long-term outcomes and to identify their best cut-off. Descriptive statistics studied the pattern of change of proteinuria and serum Cr. Results. Proteinuria of 0.6 g/d and Cr of 83 mmol/L performed independently moderately well in predicting good long-term renal outcomes while uRBC was less accurate. Combining serum Cr to proteinuria gave a small increase in positive predictive value with a trade-off in sensitivity. Proteinuria changed within the first year whereas serum Cr changed until the 7th year. Conclusions. Both proteinuria and Cr predict good long-term renal outcomes in LN. Proteinuria's ability to change faster at 12 months makes it a favorable endpoint for clinical trials and research studies.
Highlights
Systemic lupus erythematosus (SLE) is an autoimmune disease with widespread organ involvement
Caucasian Black Asian Others Age at SLE diagnosis Age at Lupus nephritis (LN) Disease duration at LN Disease scores SLEDAI-2K at LN diagnosis SDI at LN diagnosis Treatment Treated with glucocorticoids at LN Treated with antimalarials at LN Treated with immunosuppressives at LN Treated with ACE inhibitor/ARB Laboratory tests at LN diagnosis 24-hour urine proteinuria (24H-P) (g/d) median 24H-P (g/d) mean at baseline 24H-P (g/d) mean at year 1 urinary red blood cells (uRBCs) median Cr median
The majority of recent randomized clinical trials (RCTs) in LN therapeutics have resulted in nonsignificant differences compared to control groups, which at least partly has been affected by definitions of
Summary
Systemic lupus erythematosus (SLE) is an autoimmune disease with widespread organ involvement. Multiple randomized clinical trials (RCTs) have been performed in recent years investigating different therapeutic modalities for LN [2,3,4]. These RCTs have used several short-term renal parameters (common endpoints in RCTs are proteinuria, serum creatinine, and urinary sediments (Table 1)) which are potential surrogates that predict longterm response, both renal and extrarenal. The definitions of short-term parameters amongst trials are very heterogeneous wherein each trial has different definitions of partial and complete response, incorporating varying thresholds for proteinuria and serum creatinine (Cr) as well as urinary red blood cells (uRBCs) [2,3,4]. Given that the advent of new therapeutics in trials may depend upon the endpoint used to define success, there needs to be clarification of which endpoints are able to predict good long-term renal outcomes in LN
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