Evidence map›Paper›PMID 31502421›Full record

Trial reportPediatric pulmonology2019

Subcutaneous mepolizumab in children aged 6 to 11 years with severe eosinophilic asthma.

Atul Gupta, Isabelle Pouliquen, Daren Austin, Robert G Price, Rodger Kempsford, Jonathan Steinfeld, Eric S Bradford, Steven W Yancey

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Pediatric pulmonology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02377427 (An Open-label Study to Characterize the Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Subcutaneously in Children From 6 to 11 Years of Age With Severe Eosinophilic Asthma), which is not on this map. Cited by 46 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 2 pooled it
6.4field-weighted citation impact, top 3% 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.

NCT02377427 phase2completednot on this map

An Open-label Study to Characterize the Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Subcutaneously in Children From 6 to 11 Years of Age With Severe Eosinophilic Asthma

TypeinterventionalSponsorGlaxoSmithKlineRan2015 to 2018Enrolled36ConditionsAsthmaArmsMepolizumab
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 2 syntheses or guidelines pooled it, 88 citations in OpenAlex.

  1. Pooled it
  2. Safety of biologics for the treatment of asthma in children and adolescents: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2025
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Update on Pediatric asthma management: Recent advances.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026
    Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Review
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  15. Article
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  17. Observational
  18. Article
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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 at 4 institutions in 2 countries.

Atul GuptaKing's College Hospital NHS Foundation Trust, King's College London, London, UK.
Isabelle PouliquenClinical Pharmacology Modelling and Simulation, GSK, Uxbridge, Middlesex, UK.
Daren AustinClinical Pharmacology Modelling and Simulation, GSK, Uxbridge, Middlesex, UK.
Robert G PriceClinical Statistics, GSK, Stevenage, Hertfordshire, UK.
Rodger KempsfordClinical Pharmacology Modelling and Simulation, R&D Medicines Research Centre, GSK, Stevenage, Hertfordshire, UK.
Jonathan SteinfeldRespiratory TAU & Flexible Discovery Unit, GSK, Philadelphia, Pennsylvania.ORCID 0000-0002-3947-0523
Eric S BradfordRespiratory Therapeutic Area, GSK, Research Triangle Park, North Carolina.
Steven W YanceyRespiratory Therapeutic Area, GSK, Research Triangle Park, North Carolina.
Age UK · GBResearch Triangle Park Foundation · USGlaxoSmithKline (United States) · USKing's College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThere are no published reports for anti-interleukin-5 therapy in children <12 years with asthma. The primary objective of this study was to characterize the pharmacokinetics and pharmacodynamics of mepolizumab following subcutaneous (SC) administration in children 6 to 11 years-of-age with severe eosinophilic asthma. HYPOTHESIS: Mepolizumab SC pharmacokinetics and pharmacodynamics in children with severe eosinophilic asthma are comparable with adults. STUDY

designMultinational, nonrandomised, open-label (NCT02377427). PATIENT SELECTION: Children 6 to 11 years-of-age with severe eosinophilic asthma (blood eosinophil count ≥150 cells/µL at screening or ≥300 cells/µL <12 months of screening) and ≥2 exacerbations in the prior year. METHODOLOGY: Children received mepolizumab SC 40 mg (bodyweight <40 kg) or 100 mg (≥40 kg) every 4 weeks for 12 weeks.

resultsThirty-six children received mepolizumab (40 mg, n = 26; 100 mg, n = 10). Mepolizumab exposures were higher and apparent clearance lower than predicted based on prior existing data. Derived mepolizumab exposures normalized to mean bodyweight for the 40 mg and 100 mg dose groups were 454 μg * day/mL and 675 μg * day/mL, respectively. At week 12, blood eosinophils were reduced by 89% and 83% from baseline to 42 and 55 cells/µL, respectively. Mepolizumab was well tolerated; no new safety signals were observed compared with previous adult/adolescent studies.

conclusionIn children 6 to 11 years-of-age with severe eosinophilic asthma, mepolizumab SC 40 or 100 mg provided bodyweight-adjusted drug exposure within twofold of target adult exposure as well as marked reductions to blood eosinophil counts similar to adults, and although not designed to evaluate efficacy outcomes, demonstrated a positive clinical profile.

Indexed as

AdolescentAdultAntibodies, Monoclonal, HumanizedAsthmaBody WeightChildEosinophilsFemaleHumansLeukocyte CountMalePulmonary EosinophiliaAntibodies, Monoclonal, Humanizedmepolizumabasthma and early wheezechildrensevere eosinophilic asthmasubcutaneous mepolizumab

Identifiers

PMID31502421
PMCPMC6972599
OpenAlexW2972823249

What OpenQuestion holds

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LicenceCC BY-NC
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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.