Evidence map›Paper›PMID 30634202›Full record

ArticleBritish journal of clinical pharmacology2019

Optimising infliximab induction dosing for patients with ulcerative colitis.

Erwin Dreesen, Ruben Faelens, Gert Van Assche, Marc Ferrante, Séverine Vermeire, Ann Gils, Thomas Bouillon

Open access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
4.1field-weighted citation impact, top 6% 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

16 citing papers in PubMed, 33 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Raising the bar in ulcerative colitis management.Therapeutic advances in gastroenterology · 2024
    Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
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

7 authors at 1 institution in 1 country.

Erwin DreesenTherapeutic and Diagnostic Antibodies, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven - University of Leuven, Leuven, Belgium.ORCID 0000-0002-0785-2930
Ruben FaelensDrug Delivery and Disposition, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven - University of Leuven, Leuven, Belgium.
Gert Van AsscheDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
Marc FerranteDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
Séverine VermeireDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
Ann GilsTherapeutic and Diagnostic Antibodies, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven - University of Leuven, Leuven, Belgium.
Thomas BouillonDrug Delivery and Disposition, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven - University of Leuven, Leuven, Belgium.
KU Leuven · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe therapeutic failure of infliximab therapy in patients with ulcerative colitis remains a challenge even 2 decades after its approval. Therapeutic drug monitoring (TDM) has shown value during maintenance therapy, but induction therapy has still not been explored. Patients may be primary nonresponders or underexposed with the standard dosing regimen. We aimed to: (i) develop a population pharmacokinetic-pharmacodynamic model; (ii) identify the best exposure metric that predicts mucosal healing; and (iii) build an exposure-response (ER) model to demonstrate model-based dose finding during induction therapy with infliximab.

methodsData were retrospectively collected from a clinical database. A total of 583 samples, from 204 patients, was used to develop a population pharmacokinetic model to generate exposure metrics for subsequent ER modelling. A subset of 159 patients was used to develop a logistic regression ER model, describing the relationship between infliximab exposure and ordered transitions between Mayo endoscopic subscore (MES) 3, 2 and ≤1 (baseline to post-induction).

resultsA 1-compartment population pharmacokinetic model with interindividual and interoccasion variability was found to fit the data best. Covariates influencing exposure were C-reactive protein, albumin, baseline MES, fat-free mass, concomitant corticosteroid use and pancolitis. The cumulative area under the infliximab concentration-time curve until endoscopy (CAUC

conclusionsTDM-based dose individualisation targeting CAUC

Indexed as

Models, BiologicalAdultColitis, UlcerativeColonoscopyDose-Response Relationship, DrugDrug MonitoringFemaleGastrointestinal AgentsHumansInfliximabIntestinal MucosaMaleMiddle AgedRemission InductionRetrospective StudiesTreatment OutcomeGastrointestinal AgentsInfliximabexposure-responseinfliximabpharmacometricspopulation pharmacokinetics-pharmacodynamicsulcerative colitis

Identifiers

PMID30634202
PMCPMC6422726
OpenAlexW2909905375

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.