Evidence map›Paper›PMID 30663076›Full record

Trial reportAlimentary pharmacology & therapeutics2019

Vedolizumab exposure levels and clinical outcomes in ulcerative colitis: determining the potential for dose optimisation.

Mark T Osterman, Maria Rosario, Karen Lasch, Morris Barocas, Jayson D Wilbur, Nathanael L Dirks, Marc R Gastonguay

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed
–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

47 citing papers in PubMed.

  1. Trial
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  15. Review
  16. Raising the bar in ulcerative colitis management.Therapeutic advances in gastroenterology · 2024
    Review
  17. Article
  18. Review
  19. Precision medicine in inflammatory bowel disease.Precision clinical medicine · 2023
    Review
  20. 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

7 authors.

Mark T OstermanDivision of Gastroenterology, University of Pennsylvania Perelman School of Medicine, Penn Presbyterian Medical Center, Philadelphia, Pennsylvania.ORCID 0000-0002-9962-1143
Maria RosarioTakeda Pharmaceuticals International Inc, Cambridge, Massachusetts.
Karen LaschTakeda Pharmaceuticals USA, Inc, Deerfield, Illinois.
Morris BarocasTakeda Pharmaceuticals USA, Inc, Deerfield, Illinois.
Jayson D WilburMetrum Research Group, LLC, Tariffville, Connecticut.
Nathanael L DirksMetrum Research Group, LLC, Tariffville, Connecticut.
Marc R GastonguayMetrum Research Group, LLC, Tariffville, Connecticut.

Funding

Claudia Wiedemann, PhD, of Chameleon Communications International Ltd, UKTakeda
6 · The paper itself

Abstract

backgroundProspectively designed studies assessing the exposure-response profile of vedolizumab are lacking. Observational exposure-response data for vedolizumab are limited and have not been adjusted for potential confounding factors, particularly those that may affect vedolizumab clearance.

aimsTo (a) investigate the vedolizumab exposure-response relationship after adjusting for potential confounding variables; (b) propose potential target serum vedolizumab concentrations for future study; (c) ascertain whether early vedolizumab serum concentrations were associated with short- and long-term clinical outcomes in adults with ulcerative colitis in GEMINI 1.

methodsPropensity-score-based case-matching analysis was performed using data from GEMINI 1 and an earlier large population pharmacokinetic study, with vedolizumab clearance or concentration as predictors of clinical remission and response, adjusted for age, weight, anti-tumour necrosis factor alpha therapy history, serum albumin and faecal calprotectin concentrations. Potential vedolizumab concentration targets at weeks 6, 14 and steady state were proposed. Association between early vedolizumab concentrations at weeks 2, 4 and 6 and clinical remission at weeks 14 and 52 was evaluated.

resultsAmong 693 patients with pharmacokinetic data at week 6, potential target vedolizumab concentrations at weeks 6, 14 and steady state were 37.1, 18.4 and 12.7 µg/mL respectively. Week 6 was identified as the earliest time at which vedolizumab concentrations were consistently associated with clinical remission at weeks 14 and 52.

conclusionsIn this comprehensively adjusted analysis, vedolizumab concentrations at week 6 were associated with short- and long-term remission. Potential induction and maintenance target concentrations were proposed for further study.

Indexed as

AdultAntibodies, Monoclonal, HumanizedBody WeightColitis, UlcerativeDouble-Blind MethodFemaleGastrointestinal AgentsHumansLeukocyte L1 Antigen ComplexMaleMiddle AgedSerum AlbuminAntibodies, Monoclonal, HumanizedGastrointestinal AgentsLeukocyte L1 Antigen ComplexSerum Albuminvedolizumab

Identifiers

PMID30663076
PMCPMC6590294

What OpenQuestion holds

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Registered trials

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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.