Efficacy and safety of mepolizumab in Japanese patients with severe eosinophilic asthma
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- Shimoda Terufumi
- Department of Allergy, Fukuoka National Hospital
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- Odajima Hiroshi
- Department of Pediatrics, Fukuoka National Hospital
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- Okamasa Arisa
- Development and Medical Affairs Division, GSK K.K.
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- Kawase Minako
- Development and Medical Affairs Division, GSK K.K.
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- Komatsubara Masaki
- Development and Medical Affairs Division, GSK K.K.
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- Mayer Bhabita
- Clinical Statistics, GSK
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- Yancey Steven
- Respiratory Therapeutic Area, GSK
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- Ortega Hector
- Respiratory Therapeutic Area, GSK
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<p>Background: The MENSA trial assessed the efficacy and safety of mepolizumab in patients with severe eosinophilic asthma. This report describes the efficacy and safety of mepolizumab in Japanese patients from MENSA.</p><p>Methods: A post hoc analysis of the Japanese subgroup from the randomized, double-blind, placebo-controlled, double-dummy, Phase III MENSA trial (NCT01691521). Patients ≥12 years with severe eosinophilic asthma received mepolizumab 75 mg intravenously (IV), 100 mg subcutaneously (SC), or placebo, every 4 weeks for 32 weeks. The primary endpoint was the annualized rate of exacerbations. Secondary and other endpoints included annualized rate of exacerbations requiring emergency department (ED) visit/hospitalization, morning peak expiratory flow (PEF), St George's Respiratory Questionnaire (SGRQ) score and eosinophil counts. Adverse events (AEs) were monitored.</p><p>Results: In the Japanese subgroup (N = 50), the rate of clinically significant exacerbations was reduced by 90% (rate ratio [RR]: 0.10; 95% confidence interval [CI]: 0.02–0.57; P = 0.010) with mepolizumab IV and 62% (RR: 0.38; 95% CI: 0.12–1.18; P = 0.094) with mepolizumab SC, versus placebo. No exacerbations requiring ED visit/hospitalization were reported with mepolizumab IV; exacerbations were reduced by 73% (RR: 0.27; 95% CI: 0.06–1.29; P = 0.102) with mepolizumab SC versus placebo. Compared with placebo, mepolizumab IV and SC numerically increased morning PEF from baseline by 40 L/min and 13 L/min, improved quality of life by greater than the minimal clinically important difference (SGRQ: 9.5 [P = 0.083] and 7.9 [P = 0.171] points) and reduced eosinophil counts. AE incidence was similar between treatments. Results were broadly consistent with the overall population.</p><p>Conclusions: Mepolizumab was efficacious and well tolerated in Japanese patients with severe eosinophilic asthma, producing similar responses to the overall MENSA population.</p>
収録刊行物
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- Allergology International
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Allergology International 66 (3), 445-451, 2017
一般社団法人日本アレルギー学会
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詳細情報 詳細情報について
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- CRID
- 1390001204631770112
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- NII論文ID
- 130005858806
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- ISSN
- 14401592
- 13238930
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- 本文言語コード
- en
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- データソース種別
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- JaLC
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- 使用不可