Evidence map›Paper›PMID 32964238›Full record

Trial reportInflammatory bowel diseases2021

Epithelial Cell Biomarkers Are Predictive of Response to Biologic Agents in Crohn's Disease.

Mark T Osterman, Kelli L VanDussen, Ilyssa O Gordon, Elisabeth M Davis, Katherine Li, Kate Simpson, Matthew Ciorba, Sarah C Glover, Bincy Abraham, Xueyan Guo and 7 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Inflammatory bowel diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.3field-weighted citation impact, top 19% 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

6 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
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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

17 authors at 9 institutions in 1 country.

Mark T OstermanDivision of Gastroenterology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
Kelli L VanDussenDivisions of Gastroenterology, Hepatology, and Nutrition and of Developmental Biology, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Ilyssa O GordonDepartment of Pathology, Cleveland Clinic Foundation, Cleveland, OH, USA.
Elisabeth M DavisDivision of Gastroenterology and Hepatology, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Katherine LiJanssen Research and Development, Spring House, PA, USA.
Kate SimpsonDepartments of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO, USA.
Matthew CiorbaDivision of Gastroenterology and Hepatology, Washington University School of Medicine, St. Louis, MO, USA.
Sarah C GloverDivision of Gastroenterology and Hepatology, University of Florida, Gainesville, FL, USA.
Bincy AbrahamDivision of Gastroenterology and Hepatology, Houston Methodist Hospital, Houston, TX, USA.
Xueyan GuoDivision of Gastroenterology and Hepatology, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Eric U YeeDepartment of Pathology, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Felicia D AllardDepartment of Pathology, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Jacqueline G PerrigoueJanssen Research and Development, Spring House, PA, USA.
Brian ClaggettDepartment of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Bo ShenDepartment of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic Foundation, Cleveland, OH, USA.
Thaddeus S StappenbeckDepartments of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO, USA.
Julia J LiuDivision of Gastroenterology and Hepatology, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
University of Arkansas for Medical Sciences · USCleveland Clinic · USJanssen (United States) · USWashington University in St. Louis · USBrigham and Women's Hospital · USCincinnati Children's Hospital Medical Center · USMethodist Hospital · USUniversity of Florida · USUniversity of Pennsylvania · US

Funding

DEFINING THE BASIS OF EPITHELIAL DEFECTS IN CROHN'S DISEASE PATIENTSK01DK109081 · NIDDK · WASHINGTON UNIVERSITY · PI VANDUSSEN, KELLI LYNN · 2016 to 2020
$737k
NIDDK NIH HHS K01 DK109081
6 · The paper itself

Abstract

backgroundTherapeutic efficacy of biologics has remained at about 50% for 2 decades. In Crohn's disease (CD) patients, we examined the predictive value of an epithelial cell biomarker, ileal microvillar length (MVL), for clinical response to ustekinumab (UST) and vedolizumab (VDZ) and its relationship to another biomarker, intestinal epithelial cell (IEC) pyroptosis, with respect to response to VDZ.

methodIleal biopsies from the UNITI-2 randomized controlled trial were analyzed for MVL as a predictor of clinical response to UST. In a 5-center academic retrospective cohort of CD patients, ileal MVL was analyzed to determine its predictive value for response to VDZ. Correlation between ileal MVL and IEC pyroptosis was determined, and the discriminant ability of the combination of 2 biomarkers to VDZ was examined.

resultsClinical response in UST was significantly higher than placebo (65% vs 39%; P = 0.03), with patients with normal MVL (>1.7 µm) having the greatest therapeutic effect: 85% vs 20% (P = 0.02). For VDZ, clinical response with MVL of 1.35 to 1.55 µm was 82% vs 44% (<1.35 µm) and 40% (>1.55 µm; P = 0.038). There was no correlation between ileal MVL and IEC pyroptosis. The combination criteria of ileal pyroptosis <14 positive cells/1000 IECs or MVL of 1.35 to 1.55 µm could identify 84% of responders and 67% of nonresponders (P = 0.001).

conclusionIleal MVL was predictive of response to UST and VDZ in prospective and retrospective CD cohorts. It was independent of ileal IEC pyroptosis, and combination of the 2 biomarkers enhanced the discriminate ability of responders from nonresponders to VDZ.

Indexed as

Biological FactorsCrohn DiseaseGastrointestinal AgentsUstekinumabAntibodies, Monoclonal, HumanizedBiomarkersEpithelial CellsHumansProspective StudiesPyroptosisRetrospective StudiesTreatment OutcomeAntibodies, Monoclonal, HumanizedBiological FactorsBiomarkersGastrointestinal AgentsUstekinumabvedolizumabbiomarkerclinical remissionclinical responseendoscopic improvementepithelial cells

Identifiers

PMID32964238
PMCPMC8047859
OpenAlexW3088813391

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.