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Predictors of long-term renal outcome in Lupus Nephritis Trials: Lessons learned from the Euro-Lupus Nephritis Cohort.

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Dall'Era, Maria Cisternas, Miriam Smilek, Dawn Straub, Laura Houssiau, Frédéric [UCL] Mackay, Meggan

Objective: There is a need to determine which response measures in lupus nephritis trials are most predictive of good long-term renal function. We utilized data from the Euro-Lupus Nephritis Trial (ELNT) to evaluate the performance of proteinuria, serum creatinine (SCr), and urine red blood cells (RBCs) as predictors of good long-term renal outcome. Methods: ELNT subjects with measures of proteinuria, SCr, and urine RBCs at 3, 6 or 12 months and a minimum 7 year follow-up were included (n=76). We assessed the ability of these clinical biomarkers at 3, 6, and 12 months after randomization to predict good long-term renal outcome (defined as SCr ≤ 1.0mg/dL) at 7 years. Receiver operating characteristic (ROC) curves were generated to assess parameter performance at these time points and to select the best cutoff for individual parameters; sensitivity and specificity were calculated for the parameters alone and in combination. Results: Proteinuria of <0.8g/day 12 months after randomization was the single best predictor of good long-term renal function (sensitivity=81%, specificity=78%). The addition of SCr to proteinuria did not improve performance; addition of urine RBCs significantly decreased sensitivity to 47%. Conclusions: This study demonstrates that the level of proteinuria at 12 months is the individual best predictor of long-term renal outcome. Inclusion of urine RBCs as part of a composite outcome measure actually undermines the predictive value of the trial data. We therefore suggest that urine RBCs should not be included as a component of clinical trial response criteria in lupus nephritis. This article is protected by copyright. All rights reserved.

Document type Article de périodique (Journal article)
Access type Accès restreint
Publication date 2015
Language Anglais
Journal information "Arthritis & Rheumatology" - Vol. 67, no. 5, p. 1305-1313 (2015)
Peer reviewed yes
Publisher John Wiley & Sons, Inc. (Hoboken)
issn 2326-5191
e-issn 2326-5205
Publication status Publié
Affiliations UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales
UCL - (SLuc) Service de rhumatologie
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Bibliographic reference Dall'Era, Maria ; Cisternas, Miriam ; Smilek, Dawn ; Straub, Laura ; Houssiau, Frédéric ; et. al. Predictors of long-term renal outcome in Lupus Nephritis Trials: Lessons learned from the Euro-Lupus Nephritis Cohort.. In: Arthritis & Rheumatology, Vol. 67, no. 5, p. 1305-1313 (2015)
Permanent URL http://hdl.handle.net/2078.1/155279