Evidence map›Paper›PMID 31867766›Full record

Observational studyAlimentary pharmacology & therapeutics2020

A clinical decision support tool may help to optimise vedolizumab therapy in Crohn's disease.

Parambir S Dulai, Aurelien Amiot, Laurent Peyrin-Biroulet, Vipul Jairath, Melanie Serrero, Jerome Filippi, Siddharth Singh, Benjamin Pariente, Edward V Loftus, Xavier Roblin and 16 more

Erratum issuedOpen access · hybridAbstract readObservational Study
In one paragraph

Observational study in Alimentary pharmacology & therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 5% 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

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.

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  13. Leukocyte Trafficking.Gastroenterology & hepatology · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 18 institutions in 4 countries.

Parambir S DulaiLa Jolla, CA, USA.ORCID 0000-0002-9514-2321
Aurelien AmiotCreteil, France.
Laurent Peyrin-BirouletNancy, France.ORCID 0000-0003-2536-6618
Vipul JairathLondon, ON, Canada.
Melanie SerreroMarseille, France.
Jerome FilippiNice, France.
Siddharth SinghLa Jolla, CA, USA.ORCID 0000-0002-2640-7269
Benjamin ParienteLille, France.ORCID 0000-0003-1442-0244
Edward V LoftusRochester, MN, USA.ORCID 0000-0001-7199-6851
Xavier RoblinSaint-Etienne, France.ORCID 0000-0002-7929-4878
Sunanda KaneRochester, MN, USA.
Anthony BuissonClermont-Ferrand, France.
Corey A SiegelLebanon, NH, USA.
Yoram BouhnikClichy, France.
William J SandbornLa Jolla, CA, USA.ORCID 0000-0002-3314-7960
Karen LaschDeerfield, IL, USA.
Maria RosarioDeerfield, IL, USA.
Brian G FeaganLondon, ON, Canada.ORCID 0000-0002-6914-3822
Daniela BojicZurich, Switzerland.
Caroline Trang-PoissonNantes, France.ORCID 0000-0001-9140-5844
Bo ShenCleveland, OH, USA.
Romain AltweggMontpellier, France.
Bruce E SandsNew York, NY, USA.
Jean-Frederic ColombelNew York, NY, USA.ORCID 0000-0001-6472-249X
Franck CarbonnelParis, France.
GETAID OBSERV-IBD, VICTORY Cohorts Collaboration*
Groupe d'Étude Thérapeutique des Affections Inflammatoires du Tube Digestif · FRDeerfield (United States) · USMayo Clinic · USNew York Proton Center · USBicêtre Hospital · FRCentre Hospitalier Régional et Universitaire de Nancy · FRCentre Hospitalier Universitaire de Nantes · FRCentre Hospitalier Universitaire de Nice · FRCentre Hospitalier Universitaire de Saint-Étienne · FRColumbia University Irving Medical Center · USDartmouth–Hitchcock Medical Center · USHôpital Beaujon · FRLa Jolla Alcohol Research · USMicrobe, Intestine, Inflammation and Host Susceptibility · FRRobarts Clinical Trials · CAUniversity of California San Diego · USUniversity of Minnesota Rochester · USWestern University · CA

Funding

Training Grant in GastroenterologyT32DK007202 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI GHOSH, PRADIPTA · 1985 to 2022
$7.7M
Assessing Predictors of Response to Anti-Tumor Necrosis Alpha Therapy in Early Crohns DiseaseK23DK111995 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI UNGARO, RYAN · 2019 to 2023
$948k
NIDDK NIH HHS K23 DK111995NIDDK NIH HHS T32 DK007202
6 · The paper itself

Abstract

backgroundA clinical decision support tool (CDST) has been validated for predicting treatment effectiveness of vedolizumab (VDZ) in Crohn's disease.

aimTo assess the utility of this CDST for predicting exposure-efficacy and disease outcomes.

methodsUsing data from three independent datasets (GEMINI, GETAID and VICTORY), we assessed clinical remission rates and measured VDZ exposure, rapidity of onset of action, response to dose optimisation and progression to surgery by CDST-defined response groups (low, intermediate and high).

resultsA linear relationship existed between CDST-defined groups, measured VDZ exposure, rapidity of onset of action and efficacy in GEMINI through week 52 (P < 0.001 at all time points across three CDST-defined groups). In GETAID, CDST predicted differences in clinical remission at week 14 (AUC = 0.68) and rapidity of onset of action (P = 0.04) between probability groups. The high-probability patients did not benefit from shortening of infusion intervals, and differences in onset of action between the high-intermediate and low-probability groups within GETAID were no longer significant when including low-probability patients who received a week 10 infusion. CDST predicted a twofold increase in surgery risk over 12 months of VDZ therapy among low- to intermediate-probability vs high-probability patients (adjusted HR 2.06, 95% CI 1.33-3.21).

conclusionsWe further extended the clinical utility of a previously validated VDZ CDST, which accurately predicts at baseline exposure-efficacy relationships and rapidity of onset of action and could be used to help identify patients who would most benefit from interval shortening and those most likely to require surgery while on active therapy.

Indexed as

Decision Support Systems, ClinicalPatient SelectionAdultAlgorithmsAntibodies, Monoclonal, HumanizedCalibrationCohort StudiesCrohn DiseaseDrug MonitoringFemaleGastrointestinal AgentsHumansMaleMiddle AgedTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedGastrointestinal Agentsvedolizumab

Identifiers

PMID31867766
PMCPMC7028036
OpenAlexW2995103782

What OpenQuestion holds

Textmetadata
LicenceTDM
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.