A proteinuria cut-off level of 0.7 g/day after 12 months of treatment best predicts long-term renal outcome in lupus nephritis: data from the MAINTAIN Nephritis Trial

Farah Tamirou, Bernard R Lauwerys, Maria Dall'Era, Meggan Mackay, Brad Rovin, Ricard Cervera, Frédéric A Houssiau, MAINTAIN Nephritis Trial Investigators, Daniel Abramowicz, Fabiola Atzeni, Daniel Blockmans, Maria Giovanna Danieli, Luc De Clercq, David D'Cruz, Maria del Mar Ayala Guttierez, Enrique de Ramon Garrido, Inge-Magrethe Gilboe, Filip de Keyser, Michel Delahousse, Gerard Espinosa, Christoph Fiehn, Marc Golstein, Loïc Guillevin, Marco Hirsch, Alexandre Karras, Philippe Lang, Véronique le Guern, Martine Marchal, Antonio Marinho, Regina Max, Patrick Peeters, Peter Petera, Radmila Petrovic, Thomas Quémeneur, Frank Raeman, Philippe Remy, Isabelle Ravelingien, Piercarlo Sarzi-Puttini, Shirish Sangle, Maria Tektonidou, Lucia Valiente de Santis, Carlos Vasconcelos, Luc Verresen, Laurence Weiss, René Westhovens, Farah Tamirou, Bernard R Lauwerys, Maria Dall'Era, Meggan Mackay, Brad Rovin, Ricard Cervera, Frédéric A Houssiau, MAINTAIN Nephritis Trial Investigators, Daniel Abramowicz, Fabiola Atzeni, Daniel Blockmans, Maria Giovanna Danieli, Luc De Clercq, David D'Cruz, Maria del Mar Ayala Guttierez, Enrique de Ramon Garrido, Inge-Magrethe Gilboe, Filip de Keyser, Michel Delahousse, Gerard Espinosa, Christoph Fiehn, Marc Golstein, Loïc Guillevin, Marco Hirsch, Alexandre Karras, Philippe Lang, Véronique le Guern, Martine Marchal, Antonio Marinho, Regina Max, Patrick Peeters, Peter Petera, Radmila Petrovic, Thomas Quémeneur, Frank Raeman, Philippe Remy, Isabelle Ravelingien, Piercarlo Sarzi-Puttini, Shirish Sangle, Maria Tektonidou, Lucia Valiente de Santis, Carlos Vasconcelos, Luc Verresen, Laurence Weiss, René Westhovens

Abstract

Background: Although an early decrease in proteinuria has been correlated with good long-term renal outcome in lupus nephritis (LN), studies aimed at defining a cut-off proteinuria value are missing, except a recent analysis performed on patients randomised in the Euro-Lupus Nephritis Trial, demonstrating that a target value of 0.8 g/day at month 12 optimised sensitivity and specificity for the prediction of good renal outcome. The objective of the current work is to validate this target in another LN study, namely the MAINTAIN Nephritis Trial (MNT).

Methods: Long-term (at least 7 years) renal function data were available for 90 patients randomised in the MNT. Receiver operating characteristic curves were built to test the performance of proteinuria measured within the 1st year as short-term predictor of long-term renal outcome. We calculated the positive and negative predictive values (PPV, NPV).

Results: After 12 months of treatment, achievement of a proteinuria <0.7 g/day best predicted good renal outcome, with a sensitivity and a specificity of 71% and 75%, respectively. The PPV was high (94%) but the NPV low (29%). Addition of the requirement of urine red blood cells ≤5/hpf as response criteria at month 12 reduced sensitivity from 71% to 41%.

Conclusions: In this cohort of mainly Caucasian patients suffering from a first episode of LN in most cases, achievement of a proteinuria <0.7 g/day at month 12 best predicts good outcome at 7 years and inclusion of haematuria in the set of criteria at month 12 undermines the sensitivity of early proteinuria decrease for the prediction of good outcome. The robustness of these conclusions stems from the very similar results obtained in two distinct LN cohorts.

Trial registration number: NCT00204022.

Keywords: Lupus Nephritis; Outcomes research; proteinuria.

Figures

Figure 1
Figure 1
Receiver operating characteristic curves for predictive value of 24 h proteinuria at month 3 (A), month 6 (B) and month 12 (C) of patients randomised in the MAINTAIN Nephritis Trial. Sensitivity (true positive rate; y axis) is plotted against 1−specificity (false positive rate; x axis). The proteinuria (g/day) values indicated in the graphs optimise sensitivity and specificity. Figures in brackets are 95% CIs. AUC, area under the curve.

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Source: PubMed

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