TY - JOUR
T1 - Evaluation of real-world mepolizumab use in severe asthma across Europe
T2 - the SHARP experience with privacy-preserving federated analysis
AU - Kroes, Johannes A.
AU - Alfonso-Cristancho, Rafael
AU - Bansal, Aruna T.
AU - Berret, Emmanuelle
AU - Bieksiene, Kristina
AU - Bourdin, Arnaud
AU - Brussino, Luisa
AU - Canhoto, Diogo
AU - Cardini, Cristina
AU - Celik, Gulfem
AU - Csoma, Zsuzsanna
AU - Dahlén, Barbro
AU - Damadoglu, Ebru
AU - Eger, Katrien
AU - Gauquelin, Lisa
AU - Gemicioglu, Bilun
AU - Goksel, Ozlem
AU - Graff, Sophie
AU - Heffler, Enrico
AU - Hofstee, Hendrik B.
AU - Howarth, Peter
AU - Jakes, Rupert W.
AU - Jaun, Fabienne
AU - Kalinauskaite-Zukauske, Virginija
AU - Kopač, Peter
AU - Kwon, Namhee
AU - Loureiro, Claudia C.
AU - García, Victor Lozoya
AU - Masoli, Matthew
AU - Rezelj, Mariana Paula
AU - de Llano, Luis P. rez
AU - Popović-Grle, Sanja
AU - Ramos-Barbón, David
AU - Sousa, Ana S.
AU - Samitas, Konstantinos
AU - Schleich, Florence
AU - Sirena, Concetta
AU - Skrgat, Sabina
AU - Zervas, Eleftherios
AU - Zichnalis, George
AU - Bel, Elisabeth H.
AU - Sont, Jacob K.
AU - Hashimoto, Simone
AU - Brinke, Anneke Ten
N1 - Funding Information:
Support statement: This study was supported by GlaxoSmithKline (study identifier: 212821). Funding information for this article has been deposited with the Crossref Funder Registry.
Publisher Copyright:
© The authors 2023.
PY - 2023/3/1
Y1 - 2023/3/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85153727902&partnerID=8YFLogxK
U2 - 10.1183/23120541.00745-2022
DO - 10.1183/23120541.00745-2022
M3 - Article
C2 - 37020841
SN - 2044-6055
VL - 9
JO - BMJ Open
JF - BMJ Open
IS - 2
M1 - 00745-2022
ER -