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Title: | Evaluation of real-world mepolizumab use in severe asthma across Europe: the SHARP experience with privacy-preserving federated analysis | Authors: | Kroes, Johannes A Alfonso-Cristancho, Rafael Bansal, Aruna T Berret, Emmanuelle Bieksiene, Kristina Bourdin, Arnaud Brussino, Luisa Canhoto, Diogo Cardini, Cristina Celik, Gulfem Csoma, Zsuzsanna Dahlén, Barbro Damadoglu, Ebru Eger, Katrien Gauquelin, Lisa Gemicioglu, Bilun Goksel, Ozlem Graff, Sophie Heffler, Enrico Hofstee, Hendrik B. Howarth, Peter Jakes, Rupert W. Jaun, Fabienne Kalinauskaite-Zukauske, Virginija Kopač, Peter Kwon, Namhee Loureiro, Cláudia C. Lozoya García, Victor Masoli, Matthew Rezelj, Mariana Paula Pérez De Llano, Luis Popović-Grle, Sanja Ramos-Barbón, David Sà Sousa, Ana Samitas, Konstantinos Schleich, Florence Sirena, Concetta Skrgat, Sabina Zervas, Eleftherios Zichnalis, George Bel, Elisabeth H Sont, Jacob K Hashimoto, Simone Ten Brinke, Anneke |
Issue Date: | Mar-2023 | Publisher: | European Respiratory Society | Project: | GlaxoSmithKline (study identifier: 212821). Funding information for this article has been deposited with the Crossref Funder Registry. | Serial title, monograph or event: | ERJ Open Research | Volume: | 9 | Issue: | 2 | Abstract: | Background 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. Methods 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. Results 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−1, 95% CI −5.24–2.62 mg·day−1) 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. Conclusions 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. | URI: | https://hdl.handle.net/10316/113754 | ISSN: | 2312-0541 | DOI: | 10.1183/23120541.00745-2022 | Rights: | openAccess |
Appears in Collections: | FMUC Medicina - Artigos em Revistas Internacionais |
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