Evaluation of real-world mepolizumab use in severe asthma across Europe: the SHARP experience with privacy-preserving federated analysis.
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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 Claudia 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
Аннотация
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.