Evidence map›Paper›PMID 37423717›Full record

Trial reportGut2023

Mepolizumab for treatment of adolescents and adults with eosinophilic oesophagitis: a multicentre, randomised, double-blind, placebo-controlled clinical trial.

Evan S Dellon, Kathryn A Peterson, Benjamin L Mitlyng, Alina Iuga, Christine E Bookhout, Lindsay M Cortright, Kacie B Walker, Timothy S Gee, Sarah J McGee, Brenderia A Cameron and 5 more

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

Trial report in Gut, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03656380 (A Multi-center, Randomized, Double Blind, Parallel-arm, Placebo Controlled Trial of Mepolizumab for Treatment of Adults and Adolescents With Active Eosinophilic Esophagitis and Dysphagia-predominant Symptoms), which is not on this map. Cited by 52 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 6 pooled it
26.4field-weighted citation impact, top 1% 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.

NCT03656380 phase2completednot on this map

A Multi-center, Randomized, Double Blind, Parallel-arm, Placebo Controlled Trial of Mepolizumab for Treatment of Adults and Adolescents With Active Eosinophilic Esophagitis and Dysphagia-predominant Symptoms

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2019 to 2022Enrolled66ConditionsEoE, Eosinophilic EsophagitisArmsMepolizumab 300 mg, Mepolizumab 100 mg, Placebo
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 6 syntheses or guidelines pooled it, 83 citations in OpenAlex.

  1. Efficacy of Biological and Steroid Therapies in Adolescent and Adult Patients With Eosinophilic Esophagitis: A Systematic Review and Network Meta-Analysis With Meta-Regression.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2026
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Guideline
  6. Pooled it
  7. Trial
  8. Article
  9. Review
  10. Article
  11. Eosinophilic gastrointestinal diseases.Nature reviews. Disease primers · 2026
    Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Emerging Tissue and Blood Biomarkers for Eosinophilic Esophagitis.Gastroenterology clinics of North America · 2026
    Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 4 institutions in 1 country.

Evan S DellonCenter for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA edellon@med.unc.edu.ORCID 0000-0003-1167-1101
Kathryn A PetersonDepartment of Internal Medicine, Division of Gastroenterology, University of Utah, Salt Lake City, Utah, USA.
Benjamin L MitlyngMNGI Digestive Health, Minneapolis, Minnesota, USA.
Alina IugaDepartment of Pathology and Laboratory Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
Christine E BookhoutDepartment of Pathology and Laboratory Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
Lindsay M CortrightCenter for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Kacie B WalkerCenter for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Timothy S GeeCenter for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Sarah J McGeeCenter for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Brenderia A CameronCenter for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Joseph A GalankoCenter for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
John T WoosleyDepartment of Pathology and Laboratory Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
Swathi EluriCenter for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Susan E MoistCenter for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Ikuo HiranoDivision of Gastroenterology and Hepatology, Northwestern University School of Medicine, Chicago, Illinois, USA.ORCID 0000-0001-7688-9377
University of North Carolina at Chapel Hill · USMNGI Digestive Health · USNorthwestern University · USUniversity of Utah · US

Funding

Virology Research Program (Program 4)P30CA016086 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI David Darr · 1985 to 2026
$201.5M
Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
North Carolina Translational and Clinical Sciences Institute (NC TraCS)UM1TR004406 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI NICHOLAS J SHAHEEN · 2023 to 2026
$37.5M
PILOT AND FEASIBILITY STUDIESP30DK034987 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Temitope O. Keku · 1985 to 2026
$30.5M
NCATS NIH HHS UL1 TR002489NCATS NIH HHS UM1 TR004406NCI NIH HHS P30 CA016086NIDDK NIH HHS P30 DK034987
6 · The paper itself

Abstract

objectiveWe aimed to determine whether mepolizumab, an anti-IL-5 antibody, was more effective than placebo for improving dysphagia symptoms and decreasing oesophageal eosinophil counts in eosinophilic oesophagitis (EoE).

methodsWe conducted a multicentre, randomised, double-blind, placebo-controlled, trial. In the first part, patients aged 16-75 with EoE and dysphagia symptoms (per EoE Symptom Activity Index (EEsAI)) were randomised 1:1 to 3 months of mepolizumab 300 mg monthly or placebo. Primary outcome was change in EEsAI from baseline to month 3 (M3). Secondary outcomes included histological, endoscopic and safety metrics. In part 2, patients initially randomised to mepolizumab continued 300 mg monthly for 3 additional months (mepo/mepo), placebo patients started mepolizumab 100 mg monthly (pbo/mepo), and outcomes were reassessed at month 6 (M6).

resultsOf 66 patients randomised, 64 completed M3, and 56 completed M6. At M3, EEsAI decreased 15.4±18.1 with mepolizumab and 8.3±18.0 with placebo (p=0.14). Peak eosinophil counts decreased more with mepolizumab (113±77 to 36±43) than placebo (146±94 to 160±133) (p<0.001). With mepolizumab, 42% and 34% achieved histological responses of <15 and ≤6 eos/hpf compared with 3% and 3% with placebo (p<0.001 and 0.02). The change in EoE Endoscopic Reference Score at M3 was also larger with mepolizumab. At M6, EEsAI decreased 18.3±18.1 points for mepo/mepo and 18.6±19.2 for pbo/mepo (p=0.85). The most common adverse events were injection-site reactions.

conclusionsMepolizumab did not achieve the primary endpoint of improving dysphagia symptoms compared with placebo. While eosinophil counts and endoscopic severity improved with mepolizumab at 3 months, longer treatment did not yield additional improvement. TRIAL REGISTRATION NUMBER: NCT03656380.

Indexed as

Deglutition DisordersEosinophilic EsophagitisAdolescentAdultAntibodies, Monoclonal, HumanizedDouble-Blind MethodEnteritisEosinophiliaEosinophilsGastritisHumansTreatment OutcomeAntibodies, Monoclonal, HumanizedmepolizumabCLINICAL TRIALSDYSPHAGIAHISTOPATHOLOGYOESOPHAGEAL DISEASE

Identifiers

PMID37423717
PMCPMC11315207
OpenAlexW4383681987

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.