Evidence map›Paper›PMID 34089846›Full record

Trial reportClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2022

Determination of Biopsy Yield That Optimally Detects Eosinophilic Gastritis and/or Duodenitis in a Randomized Trial of Lirentelimab.

Evan S Dellon, Nirmala Gonsalves, Marc E Rothenberg, Ikuo Hirano, Mirna Chehade, Kathryn A Peterson, Gary W Falk, Joseph A Murray, Lauren T Gehman, Alan T Chang and 3 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03496571 (A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis), which is not on this map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
8.4field-weighted citation impact, top 2% 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.

NCT03496571 phase2completednot on this map

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis

TypeinterventionalSponsorAllakos Inc.Ran2018 to 2019Enrolled65ConditionsEosinophilic Gastritis, Eosinophilic GastroenteritisArmsAK002, Placebo
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 54 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Recommendations for the diagnosis and management of eosinophilic esophagitis in adults and children in Canada: a Delphi consensus project.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2025
    Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Segmental overlap is common in eosinophilic gastrointestinal diseases and impacts clinical presentation and treatment.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2025
    Article
  12. Review
  13. Article
  14. Endoscopic Features of Eosinophilic Gastrointestinal Diseases.Immunology and allergy clinics of North America · 2024
    Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. 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

13 authors at 9 institutions in 1 country.

Evan S DellonUniversity of North Carolina, Chapel Hill, North Carolina. Electronic address: edellon@med.unc.edu.
Nirmala GonsalvesDivision of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Marc E RothenbergDivision of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Ikuo HiranoDivision of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Mirna ChehadeIcahn School of Medicine at Mount Sinai, New York, New York.
Kathryn A PetersonUniversity of Utah, Salt Lake City, Utah.
Gary W FalkUniversity of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.
Joseph A MurrayMayo Clinic Rochester, Rochester, Minnesota.
Lauren T GehmanAllakos, Inc, Redwood City, California.
Alan T ChangAllakos, Inc, Redwood City, California.
Bhupinder SinghAllakos, Inc, Redwood City, California.
Henrik S RasmussenAllakos, Inc, Redwood City, California.
Robert M GentaBaylor College of Medicine, Houston, Texas.
Allakos (United States) · USNorthwestern University · USBaylor College of Medicine · USCincinnati Children's Hospital Medical Center · USIcahn School of Medicine at Mount Sinai · USMayo Clinic · USUniversity of North Carolina at Chapel Hill · USUniversity of Pennsylvania · USUniversity of Utah · US

Funding

TRAINING (CAREER DEVELOPMENT) COMPONENTU54AI117804 · NIAID · CINCINNATI CHILDRENS HOSP MED CTR · PI Nirmala P Gonsalves · 2014 to 2026
$18.5M
SLC9A3 regulation of esophageal dilated intercellular spaces in EoE SubtypesR01AI140133 · NIAID · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI HOGAN, SIMON PATRICK · 2019 to 2022
$2.5M
NIAID NIH HHS R01 AI140133NIAID NIH HHS U54 AI117804
6 · The paper itself

Abstract

BACKGROUND &

aimsEosinophilic gastritis (EG) and eosinophilic duodenitis (EoD), characterized by chronic gastrointestinal (GI) symptoms and increased numbers or activation of eosinophils and mast cells in the GI tract, are likely underdiagnosed. We aimed to determine rates of EG and EoD and number of biopsies required to optimize detection using screening data from a randomized trial of lirentelimab (AK002), an antibody against siglec-8 that depletes eosinophils and inhibits mast cells. We also characterized endoscopic features and symptoms of EG and EoD.

methodsSubjects with moderate-to-severe GI symptoms, assessed daily through a validated patient-reported outcome questionnaire, underwent endoscopy with a systematic gastric and duodenal biopsy protocol and histopathologic evaluation. EG diagnosis required presence of ≥30 eosinophils/high-power field (eos/hpf) in ≥5 hpfs and EoD required ≥30 eos/hpf in ≥3 hpfs. We analyzed diagnostic yields for EG and EoD and histologic, endoscopic, and clinical findings.

resultsOf 88 subjects meeting symptom criteria, 72 were found to have EG and/or EoD (EG/EoD), including patients with no prior diagnosis of EG/EoD. We found that GI eosinophilia was patchy and that examination of multiple biopsies was required for diagnosis-an average of only 2.6 per 8 gastric biopsies and 2.2 per 4 duodenal biopsies per subject met thresholds for EG/EoD. Evaluation of multiple nonoverlapping hpfs in each of 8 gastric and 4 duodenal biopsies was required to capture 100% of EG/EoD cases. Neither endoscopic findings nor symptom severity correlated with eosinophil counts.

conclusionsIn an analysis of patients with moderate-to-severe GI symptoms participating in a clinical trial of lirentelimab for EG/EoD, we found eosinophilia to be patchy in gastric and duodenal biopsies. Counting eosinophils in at least 8 gastric and 4 duodenal biopsies is required to identify patients with EG/EoD, so they can receive appropriate treatment. (ClinicalTrials.gov, Number: NCT03496571).

Indexed as

DuodenitisEnteritisEosinophiliaEosinophilic EsophagitisBiopsyEosinophilsGastritisHumansEGIDEosinophilic EnteritisHistologyImmune Cell

Identifiers

PMID34089846
PMCPMC8636525
OpenAlexW3169354027

What OpenQuestion holds

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Registered trials

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.