Evidence map›Paper›PMID 19264687›Full record

Trial reportThe New England journal of medicine2009

Mepolizumab for prednisone-dependent asthma with sputum eosinophilia.

Parameswaran Nair, Marcia M M Pizzichini, Melanie Kjarsgaard, Mark D Inman, Ann Efthimiadis, Emilio Pizzichini, Frederick E Hargreave, Paul M O'Byrne

5 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 463 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
463citing papers in PubMed, 11 pooled it
65.8field-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.

NCT00292877 phase2completednot on this map

The Effects of a Humanized Anti-IL-5 Monoclonal Antibody (SB-240563) on Asthma Control, Airway Eosinophilia and the Degree to Which Corticosteroid Treatment Can be Reduced to Maintain Control

TypeinterventionalSponsorSt. Joseph's Healthcare HamiltonRan2005 to 2008Enrolled20ConditionsAsthmaArmsSB-240563 (Mepolizumab)
NCT01097694 phase2completednot on this mapstarted 2010, after this paper: background citation

A 28 Week, Treatment Randomized, Double -Blind, Placebo-controlled Study of the Effects of cKit Inhibition by Imatinib in Patients With Severe Refractory Asthma (KIA)

TypeinterventionalSponsorBrigham and Women's HospitalRan2010 to 2016Enrolled176ConditionsAsthmaArmsImatinib mesylate, Placebo
NCT01520051 phase3unknown statusnot on this mapstarted 2012, after this paper: background citation

The Efficacy of Mepolizumab Treatment on Rhinovirus Induced Asthma Exacerbations

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2012 to 2014Enrolled48ConditionsAsthma, Viral InfectionArmsMepolizumab, Placebo
NCT02559791 phase2 / phase3completednot on this mapstarted 2015, after this paper: background citation

Route of Administration of Anti-IL5 Monoclonal Antibody in Prednisone-dependent Eosinophilic Asthma

TypeinterventionalSponsorMcMaster UniversityRan2015 to 2017Enrolled10ConditionsSevere Persistent Asthma, Eosinophilic BronchitisArmsReslizumab, Placebo
NCT03369574 withdrawnnot on this mapstarted 2017, after this paper: background citation

Prospective Observational Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab

TypeobservationalSponsorUniversity of RochesterRan2017 to 2018Enrolled0ConditionsChronic Rhinosinusitis (Diagnosis), Asthma, Nasal PolypsArmsReslizumab
3 · Its place in the literature

Who cites it

463 citing papers in PubMed, 11 syntheses or guidelines pooled it, 1,350 citations in OpenAlex.

  1. Biologic agents licensed for severe asthma: a systematic review and meta-analysis of randomised controlled trials.European respiratory review : an official journal of the European Respiratory Society · 2024
    Pooled it
  2. Guideline
  3. Pooled it
  4. Anti-IL-5 therapies for asthma.The Cochrane database of systematic reviews · 2022
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Mepolizumab in the treatment of eosinophilic chronic obstructive pulmonary disease.International journal of chronic obstructive pulmonary disease · 2019
    Pooled it
  10. Pooled it
  11. Anti-IL5 therapies for asthma.The Cochrane database of systematic reviews · 2017
    Pooled it
  12. Trial
  13. Trial
  14. Trial
  15. Pulmonary Innate Lymphoid Cell Responses during Rhinovirus-induced Asthma ExacerbationsAmerican journal of respiratory and critical care medicine · 2021
    Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Parameswaran NairFirestone Institute for Respiratory Health, St. Joseph's Healthcare and Department of Medicine, McMaster University, Hamilton, ON, Canada. parames@mcmaster.ca
Marcia M M Pizzichini
Melanie Kjarsgaard
Mark D Inman
Ann Efthimiadis
Emilio Pizzichini
Frederick E Hargreave
Paul M O'Byrne
McMaster University · CASt. Joseph’s Healthcare Hamilton · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEosinophilic inflammation, which may be a consequence of interleukin-5 action, is a characteristic feature of some forms of asthma. However, in three previous clinical trials involving patients with asthma, blockade of this cytokine did not result in a significant improvement in outcomes. We studied the prednisone-sparing effect of mepolizumab, a monoclonal antibody against interleukin-5, in a rare subgroup of patients who have sputum eosinophilia and airway symptoms despite continued treatment with prednisone. Secondary objectives were to examine its effect on the number of eosinophils in sputum and blood, symptoms, and airflow limitation.

methodsIn this randomized, double-blind, parallel-group trial involving patients with persistent sputum eosinophilia and symptoms despite prednisone treatment, we assigned 9 patients to receive mepolizumab (administered in five monthly infusions of 750 mg each) and 11 patients to receive placebo.

resultsThere were 12 asthma exacerbations in 10 patients who received placebo, 9 of whom had sputum eosinophilia at the time of exacerbation. In comparison, only one patient who received mepolizumab had an asthma exacerbation, and this episode was not associated with sputum eosinophilia (P=0.002). Patients who received mepolizumab were able to reduce their prednisone dose by a mean (+/-SD) of 83.8+/-33.4% of their maximum possible dose, as compared with 47.7+/-40.5% in the placebo group (P=0.04). The use of mepolizumab was associated with a significant decrease in the number of sputum and blood eosinophils. Improvements in eosinophil numbers, asthma control, and forced expiratory volume in 1 second were maintained for 8 weeks after the last infusion. There were no serious adverse events.

conclusionsMepolizumab reduced the number of blood and sputum eosinophils and allowed prednisone sparing in patients who had asthma with sputum eosinophilia despite prednisone treatment. (ClinicalTrials.gov number, NCT00292877.)

Indexed as

Administration, InhalationAdministration, OralAdrenergic beta-AgonistsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAsthmaDouble-Blind MethodDrug Therapy, CombinationEosinophiliaEosinophilsFemaleForced Expiratory VolumeGlucocorticoidsHumansInterleukin-5Leukocyte CountAdrenergic beta-AgonistsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedGlucocorticoidsInterleukin-5mepolizumabPrednisone

Identifiers

PMID19264687
OpenAlexW2062918919

What OpenQuestion holds

Textmetadata
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.