Evidence map›Paper›PMID 41417800›Full record

Observational studyPloS one2025

Protocol for an open labelled observational study in children & adolescents with severe asthma with an eosinophilic phenotype treated with mepolizumab (CASAM).

Atul Gupta, Ines de Mir Messa, Jose Valverde-Molina, Clare S Murray, Luis Moral, Javier Torres Borrego, Katharine Pike, Ana Díaz-Izquierdo, Ana Martínez-Cañavate, Prasad Nagakumar and 3 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05139381 (Open Label, Observational Study for Children & Adolescent With Severe Asthma With an Eosinophilic Phenotype Treated With Mepolizumab), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT05139381 unknown statusnot on this map

Open Label, Observational Study for Children & Adolescent With Severe Asthma With an Eosinophilic Phenotype Treated With Mepolizumab

TypeobservationalSponsorKing's College Hospital NHS TrustRan2022 to 2026Enrolled148ConditionsAsthma in ChildrenArmsMepolizumab
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

13 authors.

Atul GuptaPaediatric Respiratory Department, King's College Hospital, Department of Women and Children's Health, London, United Kingdom.ORCID https://orcid.org/0000-0002-1610-0335
Ines de Mir MessaHospital Universitari Vall Hebron, Institut de Recerca de l'Hospital Universitari Vall d'Hebron (VHIR), Barcelona, Spain.ORCID https://orcid.org/0000-0002-1418-4563
Jose Valverde-MolinaDepartment of Paediatrics, Santa Lucía General University Hospital, IMIB Biomedical Research Institute, Cartagena, Murcia, Spain.ORCID https://orcid.org/0000-0002-1971-7613
Clare S MurrayDivision of Immunology, Immunity to Infection and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester Academic Health Science Centre, and Manchester University NHS Foundation Trust, Manchester, United Kingdom.
Luis MoralPaediatric Allergy and Respiratory Unit, Alicante University General Hospital, Alicante Institute for Health, and Biomedical Research (ISABIAL - FISABIO Foundation), Alicante, Spain.
Javier Torres BorregoPaediatric Allergy and Respiratory Unit, Children's University Hospital Reina Sofia, and The Maimonides Institute for Biomedical Research of Cordoba (IMIBIC), Córdoba, Spain.
Katharine PikeBristol Royal Hospital for Children, Bristol, United Kingdom.
Ana Díaz-IzquierdoHospital Universitari Vall Hebron, Institut de Recerca de l'Hospital Universitari Vall d'Hebron (VHIR), Barcelona, Spain.
Ana Martínez-CañavateH.U. Virgen de las Nieves, Granada, Spain.
Prasad NagakumarBirmingham Women's and Children's Hospital, Birmingham, United Kingdom.
James CookPaediatric Respiratory Department, King's College Hospital, Department of Women and Children's Health, London, United Kingdom.
Latika GuptaPaediatric Respiratory Department, King's College Hospital, Department of Women and Children's Health, London, United Kingdom.
CASAM Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChildren with severe eosinophilic asthma are at an increased risk of severe exacerbations, medication side effects, impaired lung function, and significantly reduced quality of life. The advent of biologic agents aimed at eosinophilic pathways has significantly improved management options for patients with severe asthma. Mepolizumab, an anti-interleukin-5 monoclonal antibody, was approved in 2018 as an add-on maintenance treatment for patients with severe eosinophilic asthma aged ≥6 years of age. Mepolizumab's efficacy and safety is well documented in adults, but paediatric data remain limited. This real-world observational study will evaluate the long-term safety and efficacy of mepolizumab in children and adolescents, including those with comorbidities and on concomitant medications to provide a clearer picture of its performance in everyday clinical practice. METHODS AND ANALYSIS: Design: CASAM is an open label, multinational (Spain and United Kingdom), multicenter (15 Spanish and 6 UK public institutions) observational cohort study. Sample size: 150 paediatric patients on mepolizumab for SA between 6-17 years of age will be enrolled. Study Duration: Study will be conducted over 36 months (12 months pre mepolizumab initiation and 24 months after initiation). Data Collection: Pseudonymized data (prospective and retrospective) from medical charts will be collected and entered in the electronic case report forms (eCRFs) of the electronic data capture (EDC) system. Primary Outcome: To compare the rates of clinically significant asthma exacerbations in the pre-exposure and the 12-month post-exposure period with mepolizumab treatment. Protocol Version: CASAM Study_Protocol_V2.0_16th November 2023 KCH. REGISTRATION DETAILS: The study is registered with ClinicalTrials.gov (NCT05139381), IRAS number 306475.

Indexed as

Anti-Asthmatic AgentsAntibodies, Monoclonal, HumanizedAsthmaEosinophiliaAdolescentChildEosinophilsFemaleHumansMaleObservational Studies as TopicPhenotypeQuality of LifeTreatment OutcomeAnti-Asthmatic AgentsAntibodies, Monoclonal, Humanizedmepolizumab

Identifiers

PMID41417800
PMCPMC12716689

What OpenQuestion holds

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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.