Evidence map›Paper›PMID 34575443›Full record

ArticlePharmaceutics2021

External Model Performance Evaluation of Twelve Infliximab Population Pharmacokinetic Models in Patients with Inflammatory Bowel Disease.

Christina Schräpel, Lukas Kovar, Dominik Selzer, Ute Hofmann, Florian Tran, Walter Reinisch, Matthias Schwab, Thorsten Lehr

Open access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.4field-weighted citation impact, top 11% 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

13 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Antibody Drug Clearance: An Underexplored Marker of Outcomes with Checkpoint Inhibitors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Review
  9. Article
  10. Article
  11. Saudi Arabia consensus guidance for the diagnosis and management of adults with inflammatory bowel disease.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2022
    Article
  12. Observational
  13. Review
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 4 institutions in 2 countries.

Christina SchräpelClinical Pharmacy, Saarland University, 66123 Saarbrücken, Germany.ORCID 0000-0003-0155-9861
Lukas KovarClinical Pharmacy, Saarland University, 66123 Saarbrücken, Germany.ORCID 0000-0003-1832-5498
Dominik SelzerClinical Pharmacy, Saarland University, 66123 Saarbrücken, Germany.
Ute HofmannDr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, University of Tübingen, 70376 Stuttgart, Germany.ORCID 0000-0003-0823-9027
Florian TranInstitute of Clinical Molecular Biology, Kiel University and University Medical Center Schleswig-Holstein, 24105 Kiel, Germany.
Walter ReinischDepartment of Internal Medicine III, Medical University of Vienna, 1090 Vienna, Austria.
Matthias SchwabDr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, University of Tübingen, 70376 Stuttgart, Germany.
Thorsten LehrClinical Pharmacy, Saarland University, 66123 Saarbrücken, Germany.ORCID 0000-0002-8372-1465
Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology · DESaarland University · DEChristian-Albrechts-Universität zu Kiel · DEMedical University of Vienna · AT

Funding

Bundesministerium für Bildung und Forschung 031L0188DHorizon 2020 Framework Programme 643271Robert Bosch Stiftung N/A
6 · The paper itself

Abstract

Infliximab is approved for treatment of various chronic inflammatory diseases including inflammatory bowel disease (IBD). However, high variability in infliximab trough levels has been associated with diverse response rates. Model-informed precision dosing (MIPD) with population pharmacokinetic models could help to individualize infliximab dosing regimens and improve therapy. The aim of this study was to evaluate the predictive performance of published infliximab population pharmacokinetic models for IBD patients with an external data set. The data set consisted of 105 IBD patients with 336 infliximab concentrations. Literature review identified 12 published models eligible for external evaluation. Model performance was evaluated with goodness-of-fit plots, prediction- and variability-corrected visual predictive checks (pvcVPCs) and quantitative measures. For anti-drug antibody (ADA)-negative patients, model accuracy decreased for predictions > 6 months, while bias did not increase. In general, predictions for patients developing ADA were less accurate for all models investigated. Two models with the highest classification accuracy identified necessary dose escalations (for trough concentrations < 5 µg/mL) in 88% of cases. In summary, population pharmacokinetic modeling can be used to individualize infliximab dosing and thereby help to prevent infliximab trough concentrations dropping below the target trough concentration. However, predictions of infliximab concentrations for patients developing ADA remain challenging.

Indexed as

dose individualizationinflammatory bowel diseaseinfliximabmodel-informed precision dosingpopulation pharmacokinetics

Identifiers

PMID34575443
PMCPMC8468301
OpenAlexW3198775874

What OpenQuestion holds

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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.