Evidence map›Paper›PMID 24697955›Full record

ArticleBritish journal of clinical pharmacology2014

Pharmacokinetics of mycophenolate mofetil in children with lupus and clinical findings in favour of therapeutic drug monitoring.

Jean-Baptiste Woillard, Brigitte Bader-Meunier, Rémi Salomon, Bruno Ranchin, Stéphane Decramer, Michel Fischbach, Etienne Berard, Vincent Guigonis, Jérôme Harambat, Olivier Dunand and 3 more

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Article in British journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  11. Mycophenolate Metabolite Trough Concentrations Are Not Well Correlated With Dosing or Adverse Outcomes in Pediatric Heart Transplant Recipients.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Jean-Baptiste WoillardINSERM, UMR-850, F-87025, Limoges, France; University Limoges, Laboratoire de Pharmacologie Médicale, F-87025, Limoges, France; CHU Limoges, Service de Pharmacologie, Toxicologie et Pharmacovigilance, F-87042, Limoges, France.
Brigitte Bader-Meunier
Rémi Salomon
Bruno Ranchin
Stéphane Decramer
Michel Fischbach
Etienne Berard
Vincent Guigonis
Jérôme Harambat
Olivier Dunand
Julie Tenenbaum
Pierre Marquet
Franck Saint-Marcoux

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe use of mycophenolate mofetil (MMF) in children with systemic lupus erythematosus (SLE) is increasing. However, the clinical benefit of its monitoring has been scarcely studied, and little is known about its pharmacokinetics in this context. The objectives of the present study were: (i) to describe mycophenolic acid (MPA, the active moiety of MMF) pharmacokinetics, (ii) to develop a Bayesian estimator (BE) allowing the determination AUC (area under the curve) from a limited number of blood samples and (iii) to explore the relationships between exposure indices to MPA and the clinical status in children with SLE.

methodsThis was a retrospective study including 36 children with SLE, extracted from the expert system ISBA, for whom full- pharmacokinetic profiles of MPA were collected together with clinical data. A pharmacokinetic model and a BE were developed using an iterative two stage Bayesian approach. ROC curve analyses and logistic regressions were used to investigate the association of exposure and active disease.

resultsA pharmacokinetic model and a BE were developed that allowed good AUC estimation performance (bias ± SD = -0.02 ± 0.15). ROC curve analyses showed that AUC/dose <0.06 and AUC <4 mg l(-1)  h were associated with a good sensitivity and specificity for active disease (78%/94% and 94%/56%, respectively). When introduced in a logistic regression model, AUC <44 mg l(-1)  h and AUC/dose <0.06 were associated with an increased risk of active disease (OR = 21.2, 95% CI 2.3, 196.1, P = 0.007 and OR = 59.5, 95% CI 5.9, 588.2, P = 0.0005 respectively].

conclusionsThe developed pharmacokinetic BE could be used to test prospectively the interest of MPA monitoring for limiting relapse of the disease or its progression.

Indexed as

Drug MonitoringAdolescentArea Under CurveBayes TheoremChildChild, PreschoolFemaleHumansImmunosuppressive AgentsLogistic ModelsLupus Erythematosus, SystemicMaleMycophenolic AcidRetrospective StudiesImmunosuppressive AgentsMycophenolic Acidmycophenolic acidpharmacokineticsPK/PDsystemic lupus erythematosus

Identifiers

PMID24697955
PMCPMC4239980

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.