Evidence map›Paper›PMID 23040887›Full record

Trial reportThe Journal of allergy and clinical immunology2013

Long-term safety of mepolizumab for the treatment of hypereosinophilic syndromes.

Florence E Roufosse, Jean-Emmanuel Kahn, Gerald J Gleich, Lawrence B Schwartz, Anish D Singh, Lanny J Rosenwasser, Judah A Denburg, Johannes Ring, Marc E Rothenberg, Javed Sheikh and 5 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of allergy and clinical immunology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 78 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 2 pooled it
9.0field-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.

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

78 citing papers in PubMed, 2 syntheses or guidelines pooled it, 175 citations in OpenAlex.

  1. Guideline
  2. Mepolizumab in the treatment of eosinophilic chronic obstructive pulmonary disease.International journal of chronic obstructive pulmonary disease · 2019
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Real-world outcomes and corticosteroid sparing with mepolizumab for EGPA or HES.The journal of allergy and clinical immunology. Global · 2026
    Article
  9. Review
  10. Review
  11. Improving patient outcomes: Mepolizumab's impact in IL-5-mediated diseases.Lung India : official organ of Indian Chest Society · 2025
    Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. HES and EGPA: Two Sides of the Same Coin.Mayo Clinic proceedings · 2023
    Review

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

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

15 authors at 13 institutions in 8 countries.

Florence E RoufosseDepartment of Internal Medicine, Hôpital Erasme, Institute for Medical Immunology, Université Libre de Bruxelles, Gosselies, Belgium.
Jean-Emmanuel Kahn
Gerald J Gleich
Lawrence B Schwartz
Anish D Singh
Lanny J Rosenwasser
Judah A Denburg
Johannes Ring
Marc E Rothenberg
Javed Sheikh
Ann E Haig
Stephen A Mallett
Deborah N Templeton
Hector G Ortega
Amy D Klion
GlaxoSmithKline (United Kingdom) · GBResearch Triangle Park Foundation · USCentre Hospitalier Universitaire de Lille · FRChildren's Hospital & Medical Center · USErasmus Hospital · BEHadassah Medical Center · ILMcMaster University · CANational Institute of Allergy and Infectious Diseases · USSir Charles Gairdner Hospital · AUTechnical University of Munich · DEUniversity of Missouri–Kansas City · USUniversity of Utah · USVirginia Commonwealth University · US

Funding

Eosinophils and Eosinophil Activation in the Pathogenesis of Human DiseaseZIAAI001130 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI KLION, AMY · 2010 to 2025
$22.5M
Intramural NIH HHS ZIA AI001130
6 · The paper itself

Abstract

backgroundHypereosinophilic syndromes (HESs) are chronic disorders that require long-term therapy to suppress eosinophilia and clinical manifestations. Corticosteroids are usually effective, yet many patients become corticosteroid refractory or develop corticosteroid toxicity. Mepolizumab, a humanized monoclonal anti-IL-5 antibody, showed corticosteroid-sparing effects in a double-blind, placebo-controlled study of FIP1L1/PDGFRA-negative, corticosteroid-responsive subjects with HESs.

objectiveWe evaluated long-term safety and efficacy of mepolizumab (750 mg) in HES.

methodsMHE100901 is an open-label extension study. The primary end point was the frequency of adverse events (AEs). Optimal dosing frequency, corticosteroid-sparing effect of mepolizumab, and development of antimepolizumab antibodies were also explored.

resultsSeventy-eight subjects received 1 to 66 mepolizumab infusions each (including mepolizumab infusions received in the placebo-controlled trial). Mean exposure was 251 weeks (range, 4-302 weeks). The most common dosing interval was 9 to 12 weeks. The incidence of AEs was 932 events per 100 subject-years in the first year, declining to 461 events per 100 subject-years after 48 months. Serious AEs, including 1 death, were reported by the investigator as possibly due to mepolizumab in 3 subjects. The median daily prednisone dose decreased from 20.0 to 0 mg in the first 24 weeks. The median average daily dose for all subjects over the course of the study was 1.8 mg. Sixty-two percent of subjects were prednisone free without other HES medications for ≥ 12 consecutive weeks. No neutralizing antibodies were detected. Twenty-four subjects withdrew before study completion for death (n = 4), lack of efficacy (n = 6), or other reasons.

conclusionMepolizumab was well tolerated and effective as a long-term corticosteroid-sparing agent in PDGFRA-negative HES.

Indexed as

AdolescentAdrenal Cortex HormonesAdultAgedAntibodies, Monoclonal, HumanizedDouble-Blind MethodEosinophiliaFemaleHumansHypereosinophilic SyndromeMaleMiddle AgedTimeYoung AdultAdrenal Cortex HormonesAntibodies, Monoclonal, Humanizedmepolizumab

Identifiers

PMID23040887
PMCPMC3558744
OpenAlexW2061276567

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.