Evidence map›Paper›PMID 34158028›Full record

SynthesisRespiratory research2021

Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials.

Catherine Lemiere, Camille Taillé, Jason Kihyuk Lee, Steven G Smith, Stephen Mallett, Frank C Albers, Eric S Bradford, Steven W Yancey, Mark C Liu

2 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 2 registered trials, which are not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.6field-weighted citation impact, top 10% 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

13 citing papers in PubMed, 31 citations in OpenAlex.

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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 6 institutions in 4 countries.

Catherine LemiereFaculty of Medicine, Université de Montréal, Montreal, QC, Canada.
Camille TailléService de Pneumologie, Hôpital Bichat, AP-HP-Nord, Paris, France.
Jason Kihyuk LeeToronto Allergy and Asthma Clinic, Toronto, ON, Canada.
Steven G SmithRespiratory Therapeutic Area, GlaxoSmithKline, Research Triangle Park, NC, USA.
Stephen MallettClinical Statistics, GlaxoSmithKline, Stockley Park, Uxbridge, UK.
Frank C AlbersRespiratory Medical Franchise, GSK, Research Triangle Park, NC, USA.
Eric S BradfordRespiratory Therapeutic Area, GlaxoSmithKline, Research Triangle Park, NC, USA.
Steven W YanceyRespiratory Therapeutic Area, GlaxoSmithKline, Research Triangle Park, NC, USA.
Mark C LiuDivisions of Allergy and Clinical Immunology, Pulmonary and Critical Care Medicine, Johns Hopkins Asthma and Allergy Center, 5501 Hopkins Bayview Circle, Baltimore, MD, 21224, USA. mliu2@jhmi.edu.
GlaxoSmithKline (United States) · USResearch Triangle Park Foundation · USAssistance Publique – Hôpitaux de Paris · FRGlaxoSmithKline (United Kingdom) · GBHôpital du Sacré-Cœur de Montréal · CAJohns Hopkins University · US

Funding

GlaxoSmithKline 208115
6 · The paper itself

Abstract

backgroundSevere asthma is associated with a broad range of phenotypes and clinical characteristics. This analysis assessed whether select baseline patient characteristics could prognosticate mepolizumab efficacy in severe eosinophilic asthma.

methodsThis was a post hoc meta-analysis of data from the Phase III MENSA (NCT01691521/MEA115588) and MUSCA (NCT02281318/200862) studies. Patients aged ≥ 12 years with severe eosinophilic asthma and a history of exacerbations were randomised to receive placebo (MENSA/MUSCA), mepolizumab 75 mg intravenously (MENSA) or 100 mg subcutaneously (SC) (MENSA/MUSCA) every 4 weeks for 32 (MENSA) or 24 (MUSCA) weeks. The primary endpoint was the annual rate of clinically significant exacerbations; other outcomes included the proportion of patients with no exacerbations and changes from baseline in pre-bronchodilator forced expiratory volume in 1 s (FEV

resultsOverall, 936 patients received mepolizumab 100 mg SC or placebo. Across age at asthma onset, lung function and airway reversibility subgroups, mepolizumab reduced the rate of clinically significant exacerbations by 49-63% versus placebo. Improvements in lung function, SGRQ total score and ACQ-5 score were also seen with mepolizumab versus placebo across most age and lung function subgroups. Clinically significant exacerbations were reduced with mepolizumab versus placebo irrespective of season or allergen sensitivity; SGRQ total and ACQ-5 scores were generally improved across seasons.

conclusionsMepolizumab efficacy was consistent for patients with varying age at asthma onset, lung function, airway reversibility and allergen sensitivities at baseline. Our results indicate that mepolizumab is likely to be beneficial for patients with severe eosinophilic asthma with a broad range of baseline clinical characteristics; large-scale real-world studies are needed to confirm the external validity of these findings. Trial registration Post hoc meta-analysis of data from MENSA (NCT01691521/MEA115588) and MUSCA (NCT02281318/200862).

Indexed as

Antibodies, Monoclonal, HumanizedAsthmaClinical Trials, Phase III as TopicDisease ProgressionForced Expiratory VolumeHumansRandomized Controlled Trials as TopicRespiratory Function TestsSeverity of Illness IndexAntibodies, Monoclonal, HumanizedmepolizumabAirway reversibilityAllergen sensitivityAsthmaAsthma controlExacerbationsHealth-related quality of lifeLung functionMepolizumab

Identifiers

PMID34158028
PMCPMC8218390
OpenAlexW3177209562

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.