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Abstract
Mepolizumab significantly reduces the number of annual exacerbations (AEs) and the maintenance dose of systemic corticosteroids (CSs) in patients with severe eosinophilic asthma (SEA). However, there are few studies based on real life with a long-term observational period in Japan. Between July 2016 and December 2019, 24 Japanese patients received mepolizumab at Jikei University Hospital for at least 12 months. We retrospectively evaluated these characteristics, AEs and CS doses. To elucidate the predictors of the enhanced responders, we performed multivariate logistic regression analysis. After introduction, asthma symptoms improved and were maintained for over a year. The number of AEs and CS doses significantly decreased. In the subgroup analysis, the younger than 65 years-old, body mass index (BMI) < 25 kg/m2, eosinophilic chronic rhinosinusitis, or eosinophil count ≥ 400/mm3 exhibited effective reductions in either AEs or CS doses with mepolizumab treatment. The percentage change in the AEs (≤ −75%) was significantly decreased in the patients with a BMI < 25 using multivariate logistic regression analysis (odds ratio 31, 95% confidence interval: 1.4–700, P = 0.03). In real-life, BMI < 25 could be a predictor for reductions in AEs with mepolizumab treatment in the patients with SEA.Abbreviations IL, interleukin; CS, corticosteroid; SEA, severe eosinophilic asthma; BMI, body mass index; ECRS, eosinophilic chronic rhinosinusitis; CRSwNP, chronic rhinosinusitis with nasal polyps
Highlights
Asthma is a common chronic respiratory disease that affects approximately 5–10% of Japanese adults (Fukutomi et al, 2011; Ichinose et al, 2017)
The number of annual exacerbations, oral corticosteroids (OCSs) maintenance doses and FeNO levels were signifi cantly decreased, and the Asthma Control Test (ACT) score was significantly improved after treatment (Table 2)
Clinical efficacy in subgroup analyses To explore the factors that influence reductions in annual exacerbations and in maintenance CS doses, we examined the relationships of these factors with age, body mass index (BMI), eosinophilic chronic rhinosinusitis (ECRS)/chronic rhinosi nusitis with nasal polyps (CRSwNP) and peripheral eosinophil counts
Summary
Asthma is a common chronic respiratory disease that affects approximately 5–10% of Japanese adults (Fukutomi et al, 2011; Ichinose et al, 2017). Anti-interleukin-5 (IL-5) antibody, mepolizumab has been demonstrated to be an effective treatment for patients with severe eosinophilic asthma (SEA), and reductions in the annual exacerbation rates and maintenance doses of oral corticosteroids (OCSs) have been reported(Bel et al, 2014; Ortega et al, 2014). The long-term clinical efficacy and safety of this therapy have been demonstrated in open-label, largescale studies(Harvey et al, 2020; Khatri et al, 2019; Lugogo et al, 2016; Van Toor et al, 2020), but few real-life reports have shown its long-term efficacy in Japanese patients. There was few previous study which has performed a detailed examination of the efficacy of mepolizumab to identify “significant responders” in patients who responded to this treatment(Harvey et al, 2020), in Japanese patients
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