RT Journal Article SR Electronic T1 Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis JF European Respiratory Journal JO Eur Respir J FD European Respiratory Society SP 2000151 DO 10.1183/13993003.00151-2020 VO 56 IS 4 A1 Tim Harrison A1 Giorgio Walter Canonica A1 Geoffrey Chupp A1 Jason Lee A1 Florence Schleich A1 Tobias Welte A1 Antonio Valero A1 Kim Gemzoe A1 Aoife Maxwell A1 Sandra Joksaite A1 Shibing Yang A1 Peter Howarth A1 Melissa K. Van Dyke YR 2020 UL http://erj.ersjournals.com/content/56/4/2000151.abstract AB Introduction Efficacy of mepolizumab, an anti-interleukin-5 monoclonal antibody, was demonstrated in randomised controlled trials; data on its real-world impact in routine clinical practice are starting to emerge. We assessed the effectiveness and safety of mepolizumab prescribed for patients in the real world.Methods REALITI-A is a global, prospective, observational cohort study, collecting data from routine healthcare visits from patients with asthma. Patients newly prescribed mepolizumab for severe asthma with 12 months of relevant medical history pre-mepolizumab (collected retrospectively) were enrolled. An initial analysis of data from early initiators who had completed 1 year of follow-up (as of February 28, 2019) was conducted. The primary objective was to compare the rate of clinically significant exacerbations (requiring oral corticosteroids (OCS) and/or hospitalisation and/or emergency department visit) before and after mepolizumab; exacerbations requiring hospitalisation and/or emergency department visit and change in maintenance OCS use were secondary objectives. Treatment-related adverse events were reported.Results Overall, 368 mepolizumab-treated patients were included. Rates of clinically significant exacerbations were reduced by 69% from 4.63 per person per year pre-treatment to 1.43 per person per year during follow-up (p<0.001), as were those requiring hospitalisation and/or emergency department visit (from 1.14 to 0.27 per person per year; 77% reduction). In 159 patients with maintenance OCS dose data available during the pre-treatment period, median daily dose decreased from 10.0 (pre-treatment) to 5.0 mg·day−1 by week 21–24 of follow-up, sustained until week 53–56. No new safety signals were reported.Conclusion These data demonstrate that the effectiveness of mepolizumab is consistent with clinical trial results under real-world settings, with significant reductions in exacerbations and daily maintenance OCS dose.Mepolizumab has demonstrated efficacy in patients with severe eosinophilic asthma in the controlled environment of clinical trials. These initial data from the prospective REALITI-A study show that similar results are obtained in a real-world setting. https://bit.ly/3hINnFO