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Background: Innovative information techniques are increasingly used to perform federated analyses in real-world studies. Whether these techniques are suitable for harmonizing patient data from non-standardized registries and evaluating treatment outcomes needs further evidence. Aim(s): To standardize patient-level registry data from SHARP (Severe Heterogeneous Asthma Registry Patientcentred) and evaluate the effectiveness of mepolizumab on frequent (>=2/yr) exacerbations in patients with severe asthma. Method(s): We standardized data from 5,871 adults with severe asthma in 10 European countries using the OMOP Common Data Model (www.ohdsi.org). Patients who had taken mepolizumab >=1 yr (2016-2021) and had exacerbation data available were included. Changes in odds of >=2 exacerbations/yr were evaluated. Result(s): Of 2,109 patients who initiated mepolizumab 563 met inclusion criteria. Analysis showed a reduction of having >=2 (vs 0-1) annual exacerbations after 1 yr mepolizumab therapy: OR (95%CI) 0.18 (0.13-0.25)[N=369] pre and 0.08 (0.05-0.13)[N=194] during the COVID-19 pandemic (Fig). Conclusion(s): By harmonizing non-standardized, patient-level registry data and applying federated analysis we demonstrated that mepolizumab reduced asthma exacerbations, consistent with current knowledge. This paves the way for future pan-European real-world severe asthma studies using patient-level data in a privacy-proof way. (Figure Presented).
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Declaration de liens d'interets: Les auteurs declarent ne pas avoir de liens d'interets. Copyright © 2022
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OBJECTIVES: SARS-CoV-2 antibody assays are needed for serological surveys and as a complement to molecular tests to confirm COVID-19. However, the kinetics of the humoral response against SARS-CoV-2 remains poorly described and relies on the performance of the different serological tests. METHODS: In this study, we evaluated the performance of six CE-marked point-of-care tests (POC) and three ELISA assays for the diagnosis of COVID-19 by exploring seroconversions in hospitalized patients who tested positive for SARS-CoV-2 RNA. RESULTS: Both the ELISA and POC tests were able to detect SARS-CoV-2 antibodies in at least half of the samples collected seven days or more after the onset of symptoms. After 15 days, the rate of detection rose to over 80% but without reaching 100%, irrespective of the test used. More than 90% of the samples collected after 15 days tested positive using the iSIA and Accu-Tell® POC tests and the ID.Vet IgG ELISA assay. Seroconversion was observed 5 to 12 days after the onset of symptoms. Three assays suffer from a specificity below 90% (EUROIMMUN IgG and IgA, UNscience, Zhuhai Livzon). CONCLUSIONS: The second week of COVID-19 seems to be the best period for assessing the sensitivity of commercial serological assays. To achieve an early diagnosis of COVID-19 based on antibody detection, a dual challenge must be met: the immunodiagnostic window period must be shortened and an optimal specificity must be conserved.