Abstract
BackgroundComorbidities can complicate the management of severe asthma; therefore, the presence of comorbid conditions or traits often need to be considered when considering treatment options for patients with severe asthma. The aim of this analysis is to investigate the efficacy of mepolizumab in patients with severe eosinophilic asthma and comorbidities.MethodsThis was a post hoc analysis (GSK ID:209140) of data from the Phase IIb/III studies DREAM, MENSA, SIRIUS, and MUSCA. Patients aged ≥ 12 years with severe eosinophilic asthma were randomized to: mepolizumab 750, 250, or 75 mg intravenously or placebo (DREAM); mepolizumab 75 mg intravenously or 100 mg subcutaneously or placebo (MENSA); or mepolizumab 100 mg subcutaneously or placebo (SIRIUS and MUSCA) every 4 weeks for 24 weeks in SIRIUS and MUSCA, 32 weeks in MENSA or 52 weeks in DREAM. In this analysis the primary endpoint was the annual rate of clinically significant exacerbations; secondary endpoints were Asthma Control Questionnaire-5 score, St George’s Respiratory Questionnaire total score, and pre-bronchodilator forced expiratory volume in 1 s at study end. Subgroups were based on comorbidities at baseline.ResultsOverall, 1878 patients received placebo (n = 689) or mepolizumab (n = 1189). Across all comorbidity subgroups mepolizumab reduced the rate of clinically significant exacerbations by 44–68% versus placebo, improved Asthma Control Questionnaire-5 score by 0.27–0.59 points, and improved St George’s Respiratory Questionnaire total score by 5.0–11.6 points. Pre-bronchodilator forced expiratory volume in 1 s was improved by 27.1–286.9 mL in all but one comorbidity subgroup, the diabetes mellitus subgroup.ConclusionsMepolizumab reduces exacerbations, and improves asthma control, health-related quality of life, and lung function in patients with severe eosinophilic asthma despite comorbid conditions, including upper respiratory conditions, psychopathologies, cardiovascular conditions, gastroesophageal reflux disease, diabetes mellitus, and obesity.Trial registration: https://clinicaltrials.gov/ DREAM, MEA112997/NCT01000506; MENSA, MEA115588/NCT01691521; SIRIUS, MEA115575/NCT01842607; MUSCA, 200862/NCT02281318.
Highlights
Severe asthma, thought to affect 5–10% of the asthma population, is characterized by poor symptom control, frequent exacerbations, and airflow limitation, despite the regular use of maintenance therapies including multiple controllers [1, 2]
These may include primary airway conditions such as allergic rhinitis, which occurs in 55–68% of patients with severe asthma, chronic rhinosinusitis with or without nasal polyposis, occurring in 45–50% of patients with severe asthma, and vocal cord dysfunction, which affects 19–50% of the severe asthma population [8]
Other comorbid conditions are common and include gastroesophageal reflux disease (GERD), which affects 46–63% of patients with severe asthma, obesity, which occurs in 21–48% of patients with severe asthma, obstructive sleep apnea, seen in up to 88–96% of patients with severe asthma, and anxiety or depression, affecting 81% and 31% of the severe asthma population, respectively [8]
Summary
Thought to affect 5–10% of the asthma population, is characterized by poor symptom control, frequent exacerbations, and airflow limitation, despite the regular use of maintenance therapies including multiple controllers [1, 2]. Patients with severe asthma frequently exhibit comorbid conditions or traits, which add to the burden of respiratory symptoms [3,4,5,6,7]. These may include primary airway conditions such as allergic rhinitis, which occurs in 55–68% of patients with severe asthma, chronic rhinosinusitis with or without nasal polyposis, occurring in 45–50% of patients with severe asthma, and vocal cord dysfunction, which affects 19–50% of the severe asthma population [8]. The aim of this analysis is to investigate the efficacy of mepolizumab in patients with severe eosinophilic asthma and comorbidities
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