Mepolizumab decreases exacerbations in patients with eosinophilic COPD
1. In this randomized controlled trial, mepolizumab decreased the annualized rate of moderate or severe exacerbations when added to triple therapy in patients with eosinophilic chronic obstructive pulmonary Disease (COPD).
2. The incidence of adverse effects was similar between the mepolizumab and the control group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Approximately 20 to 40% of patients with COPD have signs of eosinophilic inflammation. Interleukin 5 is a key inflammatory cytokine that increases eosinophil differentiation, growth, migration, and survival. Eosinophilic inflammation can result in airway remodeling and immune dysregulation, leading to exacerbations in patients with COPD. Mepolizumab is a humanized monoclonal antibody that binds to interleukin 5 and reduces eosinophil counts in tissue and blood. This randomized controlled trial investigated the efficacy and safety of mepolizumab as compared to placebo in patients with COPD and a risk of exacerbations who had a blood eosinophil count of at least 300 cells per microlitre at screening. Patients who met inclusion criteria and were on baseline triple therapy were randomly assigned to receive mepolizumab or placebo subcutaneously every four weeks for 52 to 104 weeks. The primary end point was the annualized rate of moderate or severe exacerbations. Results from this study found that the annualized rate of moderate or severe exacerbations was significantly lower with mepolizumab than with placebo. The time to first exacerbation was longer with mepolizumab than with placebo. The incidence of adverse events was similar between groups. Overall, results from this study found that treatment with mepolizumab led to a lower annualized rate of moderate or severe exacerbations when added to baseline triple therapy in patients with eosinophilic COPD.
Click here to read the study in NEJM
In-Depth [randomized controlled trial]: This phase three, randomized, placebo-controlled trial evaluated the efficacy and safety of mepolizumab as compared with placebo in patients with eosinophilic COPD on baseline triple therapy and risk of exacerbations. Patients who were 40 years of age or older and had a diagnosis of COPD documented at least one year earlier, had at least two moderate exacerbations requiring treatment, were current or former smokers, and had a blood eosinophil count of at least 300 cells per microlitre at screening were eligible for this trial. Enrolled patients had received at least three months of inhaled triple therapy before screening. A total of 804 patients were randomized in a 1:1 ratio to receive 100 mg mepolizumab (n=403) or placebo (n=401) subcutaneously every four weeks for 52 to 104 weeks. The primary outcome of this study was the annualized rate of moderate or severe exacerbations. Results from this study found that the annualized rate of moderate or severe exacerbations was significantly lower with mepolizumab than with placebo (0.80 vs. 1.01 events per year; rate ratio, 0.79; 95% confidence interval [CI], 0.66 to 0.94; p=0.01). The time to first moderate or severe exacerbation was longer with mepolizumab than with placebo (Kaplan–Meier median time to the first moderate or severe exacerbation, 419 vs. 321 days; hazard ratio, 0.77; 95% CI, 0.64 to 0.93; p=0.009). There were no significant differences in measures of health-related quality of life, and the incidence of adverse events was similar between groups. Overall, this study concluded that treatment with mepolizumab led to a lower annualized rate of moderate or severe exacerbations when added to background inhaled triple therapy among patients with eosinophilic COPD.
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