Evidence map›Paper›PMID 31316778›Full record

ArticleUnited European gastroenterology journal2019

Early vedolizumab trough levels predict combined endoscopic and clinical remission in inflammatory bowel disease.

Jurij Hanžel, Nejc Sever, Ivan Ferkolj, Borut Štabuc, Nataša Smrekar, Tina Kurent, Matic Koželj, Gregor Novak, Griet Compernolle, Sophie Tops and 2 more

Abstract read
In one paragraph

Article in United European gastroenterology journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 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

17 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
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  11. The Role of Therapeutic Drug Monitoring in Children.Gastroenterology clinics of North America · 2023
    Review
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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

12 authors.

Jurij HanželDepartment of Gastroenterology, University Medical Centre Ljubljana, Ljubljana, Slovenia.ORCID 0000-0003-3158-8014
Nejc SeverDepartment of Gastroenterology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Ivan FerkoljDepartment of Gastroenterology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Borut ŠtabucDepartment of Gastroenterology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Nataša SmrekarDepartment of Gastroenterology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Tina KurentDepartment of Gastroenterology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Matic KoželjDepartment of Gastroenterology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Gregor NovakDepartment of Gastroenterology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Griet CompernolleDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Sophie TopsDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Ann GilsDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
David DrobneDepartment of Gastroenterology, University Medical Centre Ljubljana, Ljubljana, Slovenia.ORCID 0000-0003-2734-675X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The relationship between vedolizumab trough levels and combined endoscopic and clinical remission is unknown. Objective: To compare vedolizumab trough levels in patients with and without combined remission within the first year of treatment. Methods: We prospectively collected vedolizumab trough levels in 51 consecutive patients (28 Crohn's disease (CD) and 23 ulcerative colitis (UC)) before all infusions up to week 22, and at weeks 38 and 54, with concentrations measured after study completion. Centrally read endoscopy was performed at a median of 46 weeks. The primary outcome was combined endoscopic (CD: Simple endoscopic score for CD (SES-CD) < 4 without ulceration; UC: Mayo endoscopic subscore ≤ 1) and clinical remission (CD: resolution of abdominal pain; UC: resolution of rectal bleeding; both: resolution of altered bowel habit). Results: Median vedolizumab trough levels at weeks 6 (25.7 vs 15.6 µg/mL; Conclusion: Early vedolizumab trough levels predicted combined endoscopic and clinical remission highlighting their possible use in clinical practice.

Indexed as

ColonoscopyAdultAntibodies, Monoclonal, HumanizedAnti-Inflammatory AgentsBiomarkersDrug MonitoringFemaleHumansInflammatory Bowel DiseasesMaleMiddle AgedPrognosisRemission InductionRetreatmentROC CurveTreatment OutcomeAntibodies, Monoclonal, HumanizedAnti-Inflammatory AgentsBiomarkersvedolizumabdosing optimizationPharmacokineticstherapeutic drug monitoring

Identifiers

PMID31316778
PMCPMC6620872

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.