Evidence map›Paper›PMID 32956756›Full record

Trial reportThe Journal of allergy and clinical immunology2020

Efficacy and safety of mepolizumab in hypereosinophilic syndrome: A phase III, randomized, placebo-controlled trial.

Florence Roufosse, Jean-Emmanuel Kahn, Marc E Rothenberg, Andrew J Wardlaw, Amy D Klion, Suyong Yun Kirby, Martyn J Gilson, Jane H Bentley, Eric S Bradford, Steven W Yancey and 3 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of allergy and clinical immunology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 115 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
115citing papers in PubMed, 5 pooled it
17.7field-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.

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

115 citing papers in PubMed, 5 syntheses or guidelines pooled it, 181 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Anti-IL-5 therapies for asthma.The Cochrane database of systematic reviews · 2022
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
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  9. Trial
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  13. Article
  14. Eosinophilic gastrointestinal diseases.Nature reviews. Disease primers · 2026
    Review
  15. Article
  16. Fibrotic chronic eosinophilic pneumonia: from inflammation to fibrosis and therapeutic implications.European respiratory review : an official journal of the European Respiratory Society · 2026
    Review
  17. Real-world outcomes and corticosteroid sparing with mepolizumab for EGPA or HES.The journal of allergy and clinical immunology. Global · 2026
    Article
  18. Review
  19. Review
  20. Review

55 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

  • Commented on by
    2023
5 · Who and what money

Authors and funding

13 authors at 8 institutions in 5 countries.

Florence RoufosseDepartment of Internal Medicine, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: froufoss@ulb.ac.be.
Jean-Emmanuel KahnDepartment of Internal Medicine, Hôpital Ambroise Paré, Université Versailles-Saint Quentin-en-Yvelines, Boulogne-Billancourt, France.
Marc E RothenbergDivision of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati, Cincinnati, Ohio.
Andrew J WardlawInstitute for Lung Health, University of Leicester, Leicester, United Kingdom.
Amy D KlionNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Suyong Yun KirbyRespiratory Therapeutic Area, GSK, Research Triangle Park, NC.
Martyn J GilsonRespiratory Research and Development, GSK, Uxbridge, Middlesex, United Kingdom.
Jane H BentleyClinical Statistics, GSK, Uxbridge, Middlesex, United Kingdom.
Eric S BradfordRespiratory Therapeutic Area, GSK, Research Triangle Park, NC.
Steven W YanceyRespiratory Therapeutic Area, GSK, Research Triangle Park, NC.
Jonathan SteinfeldRespiratory Research & Development, GSK, Collegeville, Pa.
Gerald J GleichDepartment of Dermatology, School of Medicine, University of Utah, Salt Lake City, Utah.
HES Mepolizumab study group
Research Triangle Park Foundation · USCincinnati Children's Hospital Medical Center · USGlaxosmithkline (Finland) · FIHôpital Ambroise-Paré · FRNational Institute of Allergy and Infectious Diseases · USUniversité Libre de Bruxelles · BEUniversity of Leicester · GBUniversity of Utah · US

Funding

TRANSGENIC AND CHIMERIC MOUSE COREP30DK050306 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI REBECCA G WELLS · 1997 to 2026
$32.5M
Utah Center for Clinical and Translational ScienceUL1TR002538 · NCATS · UNIVERSITY OF UTAH · PI HESS, RACHEL, MAJERSIK, JENNIFER JUHL · 2018 to 2022
$26.0M
NCATS NIH HHS UL1 TR002538NIDDK NIH HHS P30 DK050306
6 · The paper itself

Abstract

backgroundAnti-IL-5 therapy is a potential treatment for patients with hypereosinophilic syndrome (HES), although its clinical efficacy is unclear.

objectiveWe sought to investigate the clinical efficacy and safety of mepolizumab versus placebo in patients with HES.

methodsThis randomized, multicenter, double-blind, placebo-controlled, phase III trial was conducted across 39 centers in 13 countries. Eligible patients had FIP1L1-PDGFRA-negative HES, experienced 2 or more flares (worsening of HES-related symptoms or blood eosinophil count requiring therapeutic escalation) in the previous 12 months, and had a screening blood eosinophil count greater than or equal to 1000 cells/μL. Patients were randomized (1:1) to subcutaneous mepolizumab (300 mg) or placebo every 4 weeks for 32 weeks, plus existing HES therapy. The primary outcome was the proportion of patients with 1 or more flares (worsening of HES-related symptoms necessitating therapy escalation or ≥2 courses of blinded rescue oral corticosteroids) during the study; in addition, patients who withdrew early from the study were counted as having a flare. Safety end points were also assessed.

resultsThe proportion of patients experiencing 1 or more flares/withdrawing from the study was 50% lower with mepolizumab versus placebo (15 of 54 [28%] vs 30 of 54 [56%]; P = .002). Logistic regression analysis was consistent with the primary analysis (odds ratio, 0.28; 95% CI, 0.12-0.64; P = .003). Similar proportions of patients in the mepolizumab and placebo groups experienced on-treatment adverse events (48 of 54 [89%] vs 47 of 54 [87%]).

conclusionsCompared with placebo, mepolizumab significantly reduced the occurrence of flares in patients with HES, with no new safety signals identified.

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedChildDouble-Blind MethodEosinophilsHumansHypereosinophilic SyndromeLeukocyte CountMiddle AgedAntibodies, Monoclonal, HumanizedmepolizumabefficacyflareHypereosinophilic syndromemepolizumabsafety

Identifiers

PMID32956756
PMCPMC9579892
OpenAlexW3041419030

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.