Evidence map›Paper›PMID 31483522›Full record

SynthesisAlimentary pharmacology & therapeutics2019

Systematic review with meta-analysis: association between vedolizumab trough concentration and clinical outcomes in patients with inflammatory bowel diseases.

Siddharth Singh, Parambir S Dulai, Niels Vande Casteele, Robert Battat, Mathurin Fumery, Brigid S Boland, William J Sandborn

Abstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis 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 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 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

35 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

7 authors.

Siddharth SinghDivision of Gastroenterology, University of California San Diego, La Jolla, California.ORCID 0000-0002-2640-7269
Parambir S DulaiDivision of Gastroenterology, University of California San Diego, La Jolla, California.ORCID 0000-0002-9514-2321
Niels Vande CasteeleDivision of Gastroenterology, University of California San Diego, La Jolla, California.ORCID 0000-0003-0854-0274
Robert BattatDivision of Gastroenterology, University of California San Diego, La Jolla, California.ORCID 0000-0002-7421-9764
Mathurin FumeryGastroenterology Unit, Amiens University and Hospital, Université de Picardie Jules Verne, Amiens, France.ORCID 0000-0002-2337-2902
Brigid S BolandDivision of Gastroenterology, University of California San Diego, La Jolla, California.
William J SandbornDivision of Gastroenterology, University of California San Diego, La Jolla, California.ORCID 0000-0002-3314-7960

Funding

UC San Diego Clinical and Translational Research InstituteKL2TR001444 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI DEPP, COLIN A. · 2015 to 2024
$15.4M
Comparative Risks and Benefits of Pharmacological Therapies for Older Patients with Inflammatory Bowel DiseasesK23DK117058 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SINGH, SIDDHARTH · 2018 to 2022
$971k
American College of GastroenterologyCrohn's and Colitis Foundation of America 404614NCATS NIH HHS KL2 TR001444NIDDK NIH HHS K23 DK117058
6 · The paper itself

Abstract

backgroundThere has been limited evaluation of the association between vedolizumab trough concentration and clinical outcomes in patients with inflammatory bowel diseases (IBD).

aimTo perform a systematic review and meta-analysis to evaluate the potential role of therapeutic drug monitoring (TDM) for vedolizumab.

methodsThrough a systematic literature search through 28 February 2019, we identified five cohort studies (558 patients, 42% with ulcerative colitis) reporting the association between vedolizumab trough concentration and clinical outcomes in patients with IBD. We calculated mean difference (MD) in vedolizumab trough concentration in patients achieving vs not achieving clinical outcomes, and qualitatively synthesized thresholds associated with favourable outcomes.

resultsIn patients with UC, median vedolizumab trough concentrations were consistently higher in patients achieving clinical remission (median, 14.3 μg/mL vs 10.5 μg/mL; MD, 5.1 μg/mL, 95% CI, 2.8-7.4) or endoscopic remission (median, 13.0 μg/mL vs 9.7; MD, 5.1 μg/mL, 95% CI, 2.2-7.9). In patients with CD, there was no significant difference in median vedolizumab trough concentrations in patients achieving vs not achieving clinical remission (MD, 2.0 μg/mL; 95% CI, -0.5 to 4.5) or endoscopic remission (MD, 3.6 μg/mL; 95% CI, -1.4 to 8.6). In patients with UC, week 6 vedolizumab trough concentrations ≥18.5-20.8 μg/mL, and maintenance trough concentrations ≥9.0-12.6 μg/mL were associated with favourable clinical outcomes. Antibodies to vedolizumab were reported in 1.7%-3.0% patients on maintenance therapy.

conclusionBased on meta-analysis, patients with UC who achieve endoscopic and clinical remission have significantly higher vedolizumab trough concentration during maintenance therapy. Vedolizumab trough concentration >20 μg/mL at week 6, and >12 μg/mL during maintenance may be associated with better outcomes, though cause-effect relationship remains unclear. Prospective studies on reactive and proactive therapeutic drug monitoring of vedolizumab (vs empiric dose escalation) are warranted.

Indexed as

Antibodies, Monoclonal, HumanizedCohort StudiesDrug MonitoringGastrointestinal AgentsHumansInflammatory Bowel DiseasesProspective StudiesRemission InductionRetrospective StudiesTreatment OutcomeAntibodies, Monoclonal, HumanizedGastrointestinal Agentsvedolizumab

Identifiers

PMID31483522
PMCPMC7083298

What OpenQuestion holds

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LicenceTDM
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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.