P130 Baseline demographics of UK mepolizumab patients in the REALITI-A study

2018 
Rationale REALITI-A is a prospective, open label, self-controlled cohort study conducted to collect observational data in real world settings from severe eosinophilic asthma (SEA) patients treated with mepolizumab. The study aims to describe mepolizumab’s use in practice to provide a more complete understanding of its value for patients. Baseline summaries of demographics of the first 92 subjects registered in the UK describe the profile of mepolizumab patients. Methods REALITI-A recruits patients to a multinational registry over a two-year period, with the primary outcome rate of clinically significant exacerbations. Baseline summaries include collection of baseline demographic data of the first 92 patients in the UK. Given the reimbursement criteria issued by NICE in England, Wales and Northern Ireland, and the SMC in Scotland, a focus here will be eosinophil levels, exacerbation rates, and use of maintenance oral corticosteroids (mOCS). Results At a data cut-off point of 30th September 2017, 92 patients were recruited in the UK and included in the baseline summary. The mean age was 49.9 years (range: 18–83), with 55 (59.8%) female patients, and mean weight 87 kg (range: 38–178). 76 patients had blood eosinophil counts measured at baseline, with a geometric mean of 408 cells per microlitre (0.408×109/L) (range: 0–1.90). 88 patients with historic blood eosinophil counts showed a geometric mean peak level of 663 cells per microlitre (0.663×109/L) (range: 0.10–8.00) over the previous twelve months. Of 89 patients with mOCS use data, 65 (73%) were on current mOCS. Of 87 patients with exacerbation history data, the mean number of exacerbations requiring OCS and/or emergency department (ED) visits and/or hospitalisation within the prior twelve months was 6.2 (range: 0–18) Furthermore, these 87 patients suffered a mean number of exacerbations requiring ED visits and/or hospitalisations of 1.6 (range: 0–10). Conclusions REALITI-A is the first real world evidence study providing UK demographic data in SEA patients treated with mepolizumab. The data indicates that patients currently treated in the UK are on the more severe end of the SEA spectrum with regards to eosinophilia and exacerbation history, exceeding NICE and SMC reimbursement requirements for mepolizumab. Funding GSK (204710)
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