Evidence map›Paper›PMID 32450626›Full record

ArticleThe Korean journal of internal medicine2021

Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies.

Mi-Kyeong Kim, Hae-Sim Park, Choon-Sik Park, Soung-Jun Min, Frank C Albers, Steven W Yancey, Bhabita Mayer, Namhee Kwon

2 registry-linked trialsAbstract read
In one paragraph

Article in The Korean journal of internal medicine, 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 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Anti-IL-5 therapies for asthma.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. 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

8 authors.

Mi-Kyeong KimDivision of Allergy and Clinical Immunology, Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Korea.
Hae-Sim ParkDepartment of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.
Choon-Sik ParkDepartment of Pulmonology and Allergy, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.
Soung-Jun MinRespiratory Medical, GSK Korea, Seoul, Korea.
Frank C AlbersGlobal Respiratory Medical Franchise, GSK, Research Triangle Park, NC, USA.
Steven W YanceyRespiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA.
Bhabita MayerClinical Statistics, GSK, Uxbridge, UK.
Namhee KwonRespiratory Medical Franchise, GSK, Brentford, UK.

Funding

GlaxoSmithKline DREAM, MEA112997/NCT01000506GlaxoSmithKline MENSA, MEA115588/ NCT01691521Korea Health Industry Development Institute HI16C0992
6 · The paper itself

Abstract

BACKGROUND/

aimsThe efficacy and safety of mepolizumab in patients with severe eosinophilic asthma has been evaluated in a global clinical trial programme. This post hoc analysis assesses the efficacy and safety of mepolizumab in Korean patients.

methodsData from Korean patients in the Phase III, placebo-controlled, randomised DREAM (MEA112997/NCT01000506) and MENSA (MEA115588/ NCT01691521) studies were included. Patients ≥ 12 years old with severe eosinophilic asthma received mepolizumab (DREAM: 75, 250 or 750 mg intravenously [IV]; MENSA: 75 mg IV or 100 mg subcutaneously [SC]), or placebo every 4 weeks for 52 weeks (DREAM) or 32 weeks (MENSA). The primary outcome was the rate of clinically significant asthma exacerbations. Secondary outcomes included forced expiratory volume in 1 second (FEV1), Asthma Control Questionnaire (ACQ) and St George's Respiratory Questionnaire (SGRQ) scores (MENSA only). Blood eosinophil counts (BEC) and safety were assessed throughout.

resultsReductions in the rate of clinically significant asthma exacerbations were observed with the approved (100 mg SC) and bioequivalent (75 mg IV) doses of mepolizumab in Korean patients who participated in DREAM and MENSA. In MENSA, trends for improvements from baseline at week 32 in pre-bronchodilator FEV1 (75 mg IV group), ACQ-5 and SGRQ scores (in both treatment groups) were seen versus placebo in Korean patients. Incidence of on-treatment adverse events was similar in Korean patients versus non-Korean patients as were observed reductions from baseline in BEC.

conclusionMepolizumab treatment provided clinical benefits for Korean patients with severe eosinophilic asthma; the safety profile is consistent with the overall population.

Indexed as

Anti-Asthmatic AgentsAsthmaAntibodies, Monoclonal, HumanizedChildHumansRepublic of KoreaAnti-Asthmatic AgentsAntibodies, Monoclonal, HumanizedmepolizumabAsthmaRepublic of KoreaSymptom flare upTherapeutics

Identifiers

PMID32450626
PMCPMC7969054

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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.