PT - JOURNAL ARTICLE AU - Tim Harrison AU - Giorgio Walter Canonica AU - Geoffrey Chupp AU - Jason Lee AU - Florence Schleich AU - Tobias Welte AU - Antonio Valero AU - Kim Gemzoe AU - Aoife Maxwell AU - Sandra Joksaite AU - Shibing Yang AU - Peter Howarth AU - Melissa K. Van Dyke TI - Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis AID - 10.1183/13993003.00151-2020 DP - 2020 Oct 01 TA - European Respiratory Journal PG - 2000151 VI - 56 IP - 4 4099 - http://erj.ersjournals.com/content/56/4/2000151.short 4100 - http://erj.ersjournals.com/content/56/4/2000151.full SO - Eur Respir J2020 Oct 01; 56 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