Evaluation of real-world mepolizumab use in severe asthma across Europe : the SHARP experience with privacy-preserving federated analysis
Kroes, Johannes Anthon (Medical Centre Leeuwarden (Leeuwarden, Països Baixos))
Alfonso Cristancho, Rafael (GlaxoSmithKline (Philadelphia, Estats Units d'Amèrica))
Bansal, Aruna T. (Acclarogen Ltd. St John's Innovation Centre (Cambridge, Regne Unit))
Berret, Emmanuelle (European Respiratory Society (Lausanne, Suïssa))
Bieksiene, Kristina (Lithuanian University of Health Sciences (Kaunas, Lituània))
Bourdin, Arnaud (University of Montpellier (Montpellier, França))
Brussino, Luisa (University of Turin (Turí, Itàlia))
Canhoto, Diogo (University of Coimbra (Coimbra, Portugal))
Cardini, Cristina (Severe Asthma Network in Italy (Milà, Itàlia))
Celik, Gülfem Elif (Ankara University School of Medicine (Ankara, Turquia))
Csoma, Zsuzsanna (National Koranyi Institute for Pulmonology (Budapest, Hongria))
Dahlén, Barbro (Karolinska Institutet (Estocolm, Suècia))
Damadoglu, Ebru (Hacettepe University (Ankara, Turquia))
Eger, Katrien (University of Amsterdam (Amsterdam, Països Baixos))
Gauquelin, Lisa (Hôpital Pitié-Salpêtière (París, França))
Gemicioglu, Bilun (Istanbul University-Cerrahpasa (Istanbul, Turquia))
Goksel, Ozlem Keskin (Ege University (Izmir, Turquia))
Graff, Sophie M. (University of Liege (Liegem Bèlgica))
Heffler, Enrico (Humanitas University (Milà, Itàlia))
Hofstee, Hendrik B. (Leiden University Medical Centre (Leiden, Països Baixos))
Howarth, Peter (GlaxoSmithKline (Londres, Regne Unit))
Jakes, Rupert W. (GlaxoSmithKline (Londres, Regne Unit))
Jaun, Fabienne (Cantonal Hospital Baselland (Liestal, Suïssa))
Kalinauskaite-Zukauske, Virginija (Lithuanian University of Health Sciences (Kaunas, Lituània))
Kopač, Peter (University of Ljubljana (Ljubljana, Eslovènia))
Kwon, Namhee (GlaxoSmithKline (Londres, Regne Unit))
Chaves Loureiro, Claudia (Centro Hospitalar e Universitário de Coimbra (Coimbra, Portugal))
Lozoya García, Victor (Evidenze Clinical Research (Madrid))
Masoli, Matthew (The Royal Devon and Exeter Hospital (Exeter, Regne Unit))
Rezelj, Mariana Paula (University Clinic of Respiratory Diseases Golnik (Golnik, Eslovènia))
Perez De Llano, Luis (Hospital Universitario Lucus Augusti (Lugo))
Popović-Grle, Sanja (University Hospital Centre Zagreb (Zagreb, Croàcia))
Ramos-Barbón, David (Institut d'Investigació Biomèdica Sant Pau)
Sousa, Ana Sà (Universidade do Porto)
Samitas, Konstantinos (Athens Chest Hospital (Atenes, Grècia))
Schleich, Florence Nicole (GIGA I3 (Liege, Bèlgica))
Sirena, Concetta (Severe Asthma Network Italy (Milà, Itàlia))
Skrgat, Sabina (University Medical Centre Ljubljana (Ljubljana, Eslovènia))
Zervas, Eleftherios (Athens Chest Hospital (Atenes, Grècia))
Zichnalis, George (LogicOne (Atenes, Grècia))
Bel, Elisabeth (University of Amsterdam (Amsterdam, Països Baixos))
Sont, Jacob K. (Leiden University Medical Centre (Leiden, Països Baixos))
Hashimoto, Simone (University of Amsterdam (Amsterdam, Països Baixos))
Ten Brinke, Anneke (Medical Centre Leeuwarden (Leeuwarden, Països Baixos))
Universitat Autònoma de Barcelona

Date:	2023
Abstract:	An objective of the Severe Heterogeneous Asthma Registry, Patient-centered (SHARP) is to produce real-world evidence on a pan-European scale by linking nonstandardised, patient-level registry data. Mepolizumab has shown clinical efficacy in randomised controlled trials and prospective real-world studies and could therefore serve as a proof of principle for this novel approach. The aim of the present study was to harmonise data from 10 national severe asthma registries and characterise patients receiving mepolizumab, assess its effectiveness on annual exacerbations and maintenance oral glucocorticoid (OCS) use, and evaluate treatment patterns. In this observational cohort study, registry data (5871 patients) were extracted for harmonisation. Where harmonisation was possible, patients who initiated mepolizumab between 1 January 2016 and 31 December 2021 were examined. Changes of a 12-month (range 11-18 months) period in frequent (two or more) exacerbations, maintenance OCS use and dose were analysed in a privacy-preserving manner using meta-analysis of generalised estimating equation parameters. Periods before and during the coronavirus disease 2019 pandemic were analysed separately. In 912 patients who fulfilled selection criteria, mepolizumab significantly reduced frequent exacerbations (OR 0. 18, 95% CI 0. 13-0. 25), maintenance OCS use (OR 0. 75, 95% CI 0. 61-0. 92) and dose (mean -3. 93 mg·day, 95% CI -5. 24-2. 62 mg·day) in the pre-pandemic group, with similar trends in the pandemic group. Marked heterogeneity was observed between registries in patient characteristics and mepolizumab treatment patterns. By harmonising patient-level registry data and applying federated analysis, SHARP demonstrated the real-world effectiveness of mepolizumab on asthma exacerbations and maintenance OCS use in severe asthma patients across Europe, consistent with previous evidence. This paves the way for future pan-European real-world severe asthma studies using patient-level data in a privacy-proof manner.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	ERJ Open Research, Vol. 9 Núm. 2 (january 2023) , p. 745-2022, ISSN 2312-0541

DOI: 10.1183/23120541.00745-2022
PMID: 37020841

14 p, 1.1 MB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles