1. There was a 27% reduction of severe asthma exacerbations in children treated with mepolizumab compared to control.
2. There were more frequent adverse events in the treatment group; however, these were mostly injection site reactions and there were no treatment-related deaths.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Asthma is responsible for 1.3 million emergency room visits per year in the United States. Proper asthma control is integral to preventing serious acute exacerbations. The use of a biologic therapy, mepolizumab, has been shown to reduce exacerbations in an adult population. This study aimed to evaluate the use of mepolizumab in racially and ethnically diverse pediatric populations. Participants were randomized 1:1 to either placebo or mepolizumab, both given as a subcutaneous injection every four weeks for 52 weeks. In the 52-week treatment period, there was a 27% rate reduction of severe exacerbations in the treatment group compared to the control. Adverse events occurred in one-third of the treatment group compared to one-tenth in the control group, with the most common being injection site reactions in both groups. There were no deaths associated with treatment. Limitations to the study include lack of follow-up post-treatment. Nevertheless, this study demonstrated the effectiveness of the use of mepolizumab at reducing asthma exacerbations in children. Additionally, there was an overall decrease in exacerbations in the placebo group, indicating the importance of consistent follow-up and guideline-based care for these children.
Click to read the study in the Lancet
Relevant Reading: Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial
In-Depth [randomized control trial]: The MUPPITS-2 study is a randomized control trial that ran in nine medical centres in the USA. Participants were enrolled through a recruitment questionnaire and were eligible if they were aged 6-17 years old with asthma for at least one year with two or more exacerbations treated with systemic corticosteroids and managed on an inhaled corticosteroid at baseline. Included participants had to live in low-income US census tracts. A total of 290 participants were randomized 1:1 to either mepolizumab (n = 146) or placebo (n = 144) and were included in the intention-to-treat analysis. Treatment with mepolizumab was in the form of a subcutaneous injection once every 4 weeks for a total of 52 weeks. The primary outcome was the recorded number of asthma exacerbations that required treatment with systemic corticosteroids within 52 weeks. The mean number of asthma exacerbations was 0.96 (95% CI 0.78-1.17) in the mepolizumab group and 1.30 (1.08-1.57) in the placebo group (RR 0.73, 0.56-0.96, p = 0.027). Adverse events occurred in 29% of the treatment group compared to 11% of the placebo. The most common adverse events were injection site reactions in both groups. One death occurred in the mepolizumab group, but this was related to an acute asthma exacerbation and not study treatment.
Image: PD
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