Evidence map›Paper›PMID 34098955›Full record

SynthesisRespiratory research2021

Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions.

Peter G Gibson, Charlene M Prazma, Geoffrey L Chupp, Eric S Bradford, Mark Forshag, Stephen A Mallett, Steve W Yancey, Steven G Smith, Elisabeth H Bel

4 registry-linked trialsOpen access · goldAbstract readMeta-AnalysisReview
In one paragraph

Synthesis in Respiratory research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
4.3field-weighted citation impact, top 5% 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.

NCT01000506 phase2completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Determine the Effect of Mepolizumab on Exacerbation Rates in Subjects With Severe Uncontrolled Refractory Asthma

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2012Enrolled621ConditionsAsthmaArmsMepolizumab 750, Mepolizumab 250, Mepolizumab 75, Placebo saline
NCT01691521 phase3completednot on this map

MEA115588 A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

TypeinterventionalSponsorGlaxoSmithKlineRan2012 to 2014Enrolled580ConditionsAsthmaArmsMepolizumab IV, Mepolizumab SC, IV Placebo, SC Placebo
NCT01842607 phase3completednot on this map

A Multi-centre, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in theMEA115588 or MEA115575 Trials

TypeinterventionalSponsorGlaxoSmithKlineRan2013 to 2015Enrolled651ConditionsAsthmaArmsMepolizumab
NCT02281318 phase3completednot on this map

A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre 24-week Study to Evaluate the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Eosinophilic Asthma on Markers of Asthma Control

TypeinterventionalSponsorGlaxoSmithKlineRan2014 to 2016Enrolled556ConditionsAsthmaArmsMepolizumab, Placebo, SOC
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
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  3. Anti-IL-5 therapies for asthma.The Cochrane database of systematic reviews · 2022
    Pooled it
  4. Observational
  5. Review
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  11. Recent Studies and Prospects of Biologics in Allergic Rhinitis Treatment.International journal of molecular sciences · 2025
    Review
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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

9 authors at 4 institutions in 3 countries.

Peter G GibsonSchool of Medicine and Public Health, University of Newcastle, Newcastle, Australia.
Charlene M PrazmaRespiratory Medical Franchise, GSK, Research Triangle Park, NC, USA. charlene.m.prazma@gsk.com.ORCID http://orcid.org/0000-0001-8455-4788
Geoffrey L ChuppYale Center for Asthma and Airways Disease (YCAAD), Yale School of Medicine, New Haven, CT, USA.
Eric S BradfordRespiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA.
Mark ForshagRespiratory Medical Franchise, GSK, Research Triangle Park, NC, USA.
Stephen A MallettClinical Statistics, GSK, Stockley Park, Uxbridge, Middlesex, UK.
Steve W YanceyRespiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA.
Steven G SmithRespiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA.
Elisabeth H BelAmsterdam University Medical Center, Location AMC, University of Amsterdam, Amsterdam, The Netherlands.
Research Triangle Park Foundation · USAmsterdam University Medical Centers · NLUniversity of Newcastle Australia · AUYale Cancer Center · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
GlaxoSmithKline ID 209140NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundComorbidities can complicate the management of severe asthma; therefore, the presence of comorbid conditions or traits often need to be considered when considering treatment options for patients with severe asthma. The aim of this analysis is to investigate the efficacy of mepolizumab in patients with severe eosinophilic asthma and comorbidities.

methodsThis was a post hoc analysis (GSK ID:209140) of data from the Phase IIb/III studies DREAM, MENSA, SIRIUS, and MUSCA. Patients aged ≥ 12 years with severe eosinophilic asthma were randomized to: mepolizumab 750, 250, or 75 mg intravenously or placebo (DREAM); mepolizumab 75 mg intravenously or 100 mg subcutaneously or placebo (MENSA); or mepolizumab 100 mg subcutaneously or placebo (SIRIUS and MUSCA) every 4 weeks for 24 weeks in SIRIUS and MUSCA, 32 weeks in MENSA or 52 weeks in DREAM. In this analysis the primary endpoint was the annual rate of clinically significant exacerbations; secondary endpoints were Asthma Control Questionnaire-5 score, St George's Respiratory Questionnaire total score, and pre-bronchodilator forced expiratory volume in 1 s at study end. Subgroups were based on comorbidities at baseline.

resultsOverall, 1878 patients received placebo (n = 689) or mepolizumab (n = 1189). Across all comorbidity subgroups mepolizumab reduced the rate of clinically significant exacerbations by 44-68% versus placebo, improved Asthma Control Questionnaire-5 score by 0.27-0.59 points, and improved St George's Respiratory Questionnaire total score by 5.0-11.6 points. Pre-bronchodilator forced expiratory volume in 1 s was improved by 27.1-286.9 mL in all but one comorbidity subgroup, the diabetes mellitus subgroup.

conclusionsMepolizumab reduces exacerbations, and improves asthma control, health-related quality of life, and lung function in patients with severe eosinophilic asthma despite comorbid conditions, including upper respiratory conditions, psychopathologies, cardiovascular conditions, gastroesophageal reflux disease, diabetes mellitus, and obesity.

trial registrationhttps://clinicaltrials.gov/ DREAM, MEA112997/NCT01000506; MENSA, MEA115588/NCT01691521; SIRIUS, MEA115575/NCT01842607; MUSCA, 200862/NCT02281318.

Indexed as

Antibodies, Monoclonal, HumanizedAsthmaComorbidityDisease ProgressionDose-Response Relationship, DrugForced Expiratory VolumeHumansInjections, IntravenousRandomized Controlled Trials as TopicSeverity of Illness IndexAntibodies, Monoclonal, HumanizedmepolizumabCardiovascularComorbiditiesMepolizumabSevere eosinophilic asthmaTreatable traitsUpper respiratory

Identifiers

PMID34098955
PMCPMC8182929
OpenAlexW3169195900

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.