Evidence map›Paper›PMID 19756557›Full record

Trial reportEuropean journal of clinical pharmacology2009

Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis.

Adedigbo A Fasanmade, Omoniyi J Adedokun, Joyce Ford, Danika Hernandez, Jewel Johanns, Chuanpu Hu, Hugh M Davis, Honghui Zhou

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03669029 (Optimization of Golimumab Treatment in Ulcerative Colitis), which is not on this map. Cited by 149 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
149citing papers in PubMed, 5 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.

NCT03669029 phase4unknown statusnot on this mapstarted 2018, after this paper: background citation

Optimization of Golimumab Treatment in Ulcerative Colitis

TypeinterventionalSponsorHospital de ManisesRan2018 to 2019Enrolled50ConditionsColitis, UlcerativeArmsGolimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg, Golimumab treatment optimization.
3 · Its place in the literature

Who cites it

149 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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89 more citing papers are in PubMed but not listed here.

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.

Adedigbo A FasanmadeCentocor Research and Development, Inc, Malvern, PA, USA. afasanma@its.jnj.com
Omoniyi J Adedokun
Joyce Ford
Danika Hernandez
Jewel Johanns
Chuanpu Hu
Hugh M Davis
Honghui Zhou

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeInfliximab, a monoclonal antibody, is approved for the treatment of inflammatory diseases at doses that depend on the patient disease population. It was the aim of this study to evaluate its population pharmacokinetics in patients with moderately to severely active ulcerative colitis and characterize patient covariates that affect its disposition in this population.

methodsInformation collected from 482 patients in two randomized, double-blind, placebo-controlled international studies were analyzed using NONMEM.

resultsA two-compartment, population pharmacokinetic model described the serum infliximab concentration-time data. Population pharmacokinetic estimates (typical value +/- standard error), based on the final covariate model, were clearance (CL: 0.407 +/- 0.0103 L/day), apparent volumes of distribution in the central (V(1): 3.29 +/- 0.0679 L) and peripheral (V(2): 4.13 +/- 0.16 L) compartments, and intercompartment clearance (Q: 7.14 +/- 0.489 L/day). Infliximab exhibited interindividual variability for CL and V(1) of 37.7% and 22.1%, respectively. Infliximab t(1/2) is approximately 14 days. Covariate analysis showed that V(1) increased as body weight increased, and CL was higher in patients who developed antibodies to infliximab. An additional novel covariate, serum albumin concentration, was found to be inversely and strongly related to infliximab clearance in this population.

conclusionsThe disposition of infliximab in patients with moderately to severely active ulcerative colitis, unlike in rheumatoid arthritis, was not affected by coadministration of immunomodulators and corticosteroids but was related to formation of antibodies to infliximab and, notably, to serum albumin levels.

Indexed as

AdultAntibodies, MonoclonalAnti-Inflammatory AgentsBayes TheoremColitis, UlcerativeDouble-Blind MethodFemaleHumansInfliximabMaleModels, BiologicalPlacebosSerum AlbuminSeverity of Illness IndexSex FactorsAntibodies, MonoclonalAnti-Inflammatory AgentsInfliximabPlacebosSerum Albumin

Identifiers

PMID19756557
PMCPMC2778780

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Registered trials

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.