Mepolizumab effectiveness in severe asthma supported by federated analysis of European SHARP data

Abstract

<b>Background:</b> 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. <b>Aim:</b> To standardize patient-level registry data from SHARP (Severe Heterogeneous Asthma Registry Patient-centred) and evaluate the effectiveness of mepolizumab on frequent (≥2/yr) exacerbations in patients with severe asthma. <b>Methods:</b> 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. <b>Results:</b> 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). <b>Conclusions:</b> 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. Supported by GSK (212821).