Evidence map›Paper›PMID 29949045›Full record

Trial reportAdvances in therapy2018

Rapid and Consistent Improvements in Morning PEF in Patients with Severe Eosinophilic Asthma Treated with Mepolizumab.

Hector Ortega, Andrew Menzies-Gow, Jean-Pierre Llanos, Mark Forshag, Frank Albers, Necdet Gunsoy, Eric S Bradford, Steven W Yancey, Monica Kraft

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 15% 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.

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
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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. StoppingThe European respiratory journal · 2022
    Trial
  3. Trial
  4. Review
  5. Improving patient outcomes: Mepolizumab's impact in IL-5-mediated diseases.Lung India : official organ of Indian Chest Society · 2025
    Article
  6. Article
  7. Article
  8. Article
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 5 institutions in 2 countries.

Hector OrtegaRespiratory US Medical Affairs, GlaxoSmithKline, La Jolla, CA, USA. hectorortega15@hotmail.com.
Andrew Menzies-GowRespiratory Medicine, Royal Brompton Hospital, London, UK.
Jean-Pierre LlanosRespiratory US Medical Affairs, GlaxoSmithKline, Research Triangle Park, NC, USA.
Mark ForshagRespiratory US Medical Affairs, GlaxoSmithKline, Research Triangle Park, NC, USA.
Frank AlbersRespiratory Therapeutic Area Unit, GlaxoSmithKline, Research Triangle Park, NC, USA.
Necdet GunsoyClinical Statistics, GlaxoSmithKline, Stockley Park, Middlesex, UK.
Eric S BradfordRespiratory Therapeutic Area Unit, GlaxoSmithKline, Research Triangle Park, NC, USA.
Steven W YanceyRespiratory Therapeutic Area Unit, GlaxoSmithKline, Research Triangle Park, NC, USA.
Monica KraftDepartment of Medicine, University of Arizona, Tucson, AZ, USA.
GlaxoSmithKline (United States) · USResearch Triangle Park Foundation · USGlaxoSmithKline (United Kingdom) · GBRoyal Brompton Hospital · GBUniversity of Arizona · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPrevious studies showed that mepolizumab significantly reduces exacerbations and oral corticosteroid use in patients with severe eosinophilic asthma. However, early studies reported inconsistent effects on lung function. This study specifically assessed the onset of clinical effect and the relationship of baseline blood eosinophil count of mepolizumab 100 mg subcutaneous (SC) administration on morning peak expiratory flow (AM PEF).

methodsPost hoc analysis of data from two randomized, double-blind, placebo-controlled studies (MENSA, NCT01691521; MUSCA, NCT02281318) of 4-weekly mepolizumab 100 mg versus placebo in patients with severe eosinophilic asthma. Individual study results were generated using a mixed model repeated measures model controlling for multiple covariates and were combined using a fixed effects meta-analysis via inverse-variance weighting.

resultsSignificant improvements in AM PEF after the first dose of mepolizumab 100 mg SC vs. placebo were seen as early as week 1 and continued to improve further with subsequent doses. The mean change in AM PEF was 26 L/min in the mepolizumab group compared to 4 L/min in the placebo group, p < 0.001. When the population was stratified by blood eosinophil thresholds the mean difference from placebo was 24 L/min (≥ 150 cells/µL), 27 L/min (≥ 300 cells/µL), and 34 L/min (≥ 500 cells/µL), p < 0.001 for all subgroups. The < 150 cells/µL (≥ 300 cells/µL in the previous year) group increased 13 L/min, while both 150 to < 300 cells/µL and 300 to < 500 cells/µL ranges demonstrated comparable changes (19 L/min and 17 L/min), respectively.

conclusionOur analysis has shown early and consistent improvements in lung function measured by AM PEF using the study enrollment criterion of ≥ 150 eosinophils/µL. We also identified a relationship between baseline blood eosinophils and improvements in AM PEF with mepolizumab in patients with severe eosinophilic asthma.

fundingGlaxoSmithKline (study ID 208091).

Indexed as

AsthmaEosinophilsAdultAnti-Asthmatic AgentsAntibodies, Monoclonal, HumanizedDouble-Blind MethodDrug MonitoringFemaleHumansInjections, SubcutaneousLeukocyte CountMaleMiddle AgedPeak Expiratory Flow RateRespiratory Function TestsTreatment OutcomeAnti-Asthmatic AgentsAntibodies, Monoclonal, HumanizedmepolizumabAM PEFAnti-IL-5Blood eosinophilsLung functionMonoclonal antibodyRespiratorySevere asthma

Identifiers

PMID29949045
PMCPMC11343775
OpenAlexW2808616632

What OpenQuestion holds

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LicenceCC BY-NC
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.