Abstract
BackgroundMepolizumab (100 mg delivered s.c. every 4 weeks) is indicated for add-on maintenance treatment for patients with severe eosinophilic asthma. Mepolizumab has been shown to reduce exacerbations and the requirement for daily oral corticosteroids, and improve asthma control and symptoms. However, data on the durability of the response to mepolizumab during dosing periods are limited. The aim of this study was to investigate the efficacy profile in patients with severe eosinophilic asthma over the 4-weekly dosing period for various fixed mepolizumab doses.MethodsThis was a post hoc analysis of data from the phase IIb/III DREAM study. Patients ≥12 years of age with severe eosinophilic asthma were randomised (1:1:1:1) to receive intravenous mepolizumab 75 mg (equivalent to 100 mg s.c.), 250 mg, 750 mg or placebo, plus standard of care, every 4 weeks for 52 weeks. The number of exacerbations and eDiary data (peak expiratory flow, rescue medication use and symptom scores) from two periods in each 4-weekly dosing interval (days 1–14 and 15–28) over the 52-week treatment period were analysed.FindingseDiary data and the proportion of patients experiencing ≥1 exacerbation were similar during the first and second 2 weeks of a dosing period across all mepolizumab doses.InterpretationThese results demonstrate that the response to mepolizumab is sustained over the 4-weekly dosing period with no differences across a 10-fold dose range and supports the use of the current mepolizumab dosing regimen in patients with severe eosinophilic asthma.
Highlights
Asthma is a heterogeneous disease consisting of several inflammatory sub-phenotypes, one of which is severe eosinophilic asthma [1, 2]
Clinical trials have demonstrated that mepolizumab treatment reduces blood eosinophil counts, the rate of clinically significant exacerbations, and the requirement for daily oral corticosteroids (OCSs) use, and improves lung function, asthma control, and health-related quality of life compared with placebo in patients with severe eosinophilic asthma [7–10]
When data were analysed according to baseline blood eosinophil count, there was no obvious difference between patients with
Summary
Asthma is a heterogeneous disease consisting of several inflammatory sub-phenotypes, one of which is severe eosinophilic asthma [1, 2]. Clinical trials have demonstrated that mepolizumab treatment reduces blood eosinophil counts, the rate of clinically significant exacerbations, and the requirement for daily OCS use, and improves lung function, asthma control, and health-related quality of life compared with placebo in patients with severe eosinophilic asthma [7–10]. The phase IIb/III DREAM (Dose Ranging Efficacy And safety with Mepolizumab in severe asthma) study demonstrated that mepolizumab treatment with either 75 mg (bioequivalent to 100 mg s.c.) [11], 250 mg, or 750 mg (intravenous (i.v.) administration) was associated with reductions in the rate of exacerbations and blood eosinophil counts, with minimal differences seen across the three treatment groups [9]. Interpretation: These results demonstrate that the response to mepolizumab is sustained over the 4-weekly dosing period with no differences across a 10-fold dose range and supports the use of the current mepolizumab dosing regimen in patients with severe eosinophilic asthma
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