Evidence map›Paper›PMID 31287855›Full record

ArticleInflammatory bowel diseases2020

Improved Population Pharmacokinetic Model for Predicting Optimized Infliximab Exposure in Pediatric Inflammatory Bowel Disease.

Laura E Bauman, Ye Xiong, Tomoyuki Mizuno, Philip Minar, Tsuyoshi Fukuda, Min Dong, Michael J Rosen, Alexander A Vinks

Open access · greenAbstract read
In one paragraph

Article in Inflammatory bowel diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 5% of its field
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

41 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.

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  9. The Coming of Age of Model-Informed Precision Therapeutics for Children.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025
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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

8 authors at 3 institutions in 1 country.

Laura E BaumanDepartment of Pediatrics, University of California San Diego, La Jolla, California, USA.
Ye XiongDivision of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Tomoyuki MizunoDivision of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Philip MinarDivision of Gastroenterology, Hepatology, and Nutrition, Cincinnati, Ohio, USA.
Tsuyoshi FukudaDivision of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Min DongDivision of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Michael J RosenDivision of Gastroenterology, Hepatology, and Nutrition, Cincinnati, Ohio, USA.
Alexander A VinksDivision of Gastroenterology, Hepatology, and Nutrition, Cincinnati, Ohio, USA.
Cincinnati Children's Hospital Medical Center · USUniversity of Cincinnati · USUniversity of Cincinnati Medical Center · US

Funding

Stem Cell/Organoid and Genome Editing CoreP30DK078392 · NIDDK · CINCINNATI CHILDRENS HOSP MED CTR · PI Theresa Alenghat · 2007 to 2026
$24.4M
PEDIATRIC GASTROENTEROLOGY AND NUTRITION TRAINING GRANTT32DK007727 · NIDDK · CINCINNATI CHILDRENS HOSP MED CTR · PI Phillip P Minar · 1995 to 2026
$11.3M
T32 Cincinnati Pediatric Clinical Pharmacology Training ProgramT32HD069054 · NICHD · CINCINNATI CHILDRENS HOSP MED CTR · PI TRACY A GLAUSER, Sonya C Tang Girdwood · 2011 to 2026
$3.0M
Th2 Cytokines and Signaling in Pediatric Inflammatory Bowel DiseaseK23DK094832 · NIDDK · VANDERBILT UNIVERSITY · PI ROSEN, MICHAEL J · 2013 to 2017
$900k
NICHD NIH HHS T32 HD069054NIDDK NIH HHS K23 DK094832NIDDK NIH HHS P30 DK078392NIDDK NIH HHS T32 DK007727
6 · The paper itself

Abstract

backgroundMany pediatric patients with inflammatory bowel disease (IBD) lose response to infliximab (IFX) within the first year, and achieving a minimal target IFX trough concentration is associated with higher remission rates and longer durability. Population pharmacokinetic (PK) modeling can predict trough concentrations for individualized dosing. The object of this study was to refine a population PK model that accurately predicts individual IFX exposure during maintenance therapy using longitudinal real-practice data.

methodsWe exported data from the electronic health records of pediatric patients with IBD treated with originator IFX at a single center between January 2011 and March 2017. Subjects were divided into discovery and validation cohorts. A population PK model was built and then validated.

resultsWe identified 228 pediatric patients with IBD who received IFX and had at least 1 drug concentration measured, including 135 and 93 patients in the discovery and validation cohorts, respectively. Weight, albumin, antibodies to IFX (ATI) detected by a drug-tolerant assay, and erythrocyte sedimentation rate (ESR) were identified as covariates significantly associated with IFX clearance and incorporated into the model. The model exhibited high accuracy for predicting target IFX trough concentrations with an area under the receiver operating characteristic curve (AUROC) of 0.86 (95% confidence interval [CI], 0.81-0.91) for population-based predictions without prior drug-level input. Accuracy increased further for individual-based predictions when prior drug levels were known, with an AUROC of 0.93 (95% CI, 0.90-0.97).

conclusionsA population PK model utilizing weight, albumin, ordinal drug-tolerant ATI, and ESR accurately predicts IFX trough concentrations during maintenance therapy in real-practice pediatric patients with IBD. This model, which incorporates dynamic clinical information, could be used for individualized dosing decisions to increase response durability.

Indexed as

Drug MonitoringAdolescentArea Under CurveBlood SedimentationChildFemaleGastrointestinal AgentsHumansInflammatory Bowel DiseasesInfliximabMaleMetabolic Clearance RateRetrospective StudiesROC CurveSerum AlbuminGastrointestinal AgentsInfliximabSerum Albuminbiological drugCrohn’s diseaseindividual dosingpharmacokinetic modelulcerative colitis

Identifiers

PMID31287855
PMCPMC7171445
OpenAlexW2962783208

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.