Shimoda Terufumi, Odajima Hiroshi, Okamasa Arisa, Kawase Minako, Komatsubara Masaki, Mayer Bhabita, Yancey Steven, Ortega Hector
Department of Allergy, Fukuoka National Hospital, Fukuoka, Japan.
Department of Pediatrics, Fukuoka National Hospital, Fukuoka, Japan.
Allergol Int. 2017 Jul;66(3):445-451. doi: 10.1016/j.alit.2016.11.006. Epub 2017 Jan 16.
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.
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.
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.
Mepolizumab was efficacious and well tolerated in Japanese patients with severe eosinophilic asthma, producing similar responses to the overall MENSA population.
MENSA试验评估了美泊利珠单抗在重度嗜酸性粒细胞性哮喘患者中的疗效和安全性。本报告描述了MENSA试验中日本患者使用美泊利珠单抗的疗效和安全性。
对随机、双盲、安慰剂对照、双模拟、III期MENSA试验（NCT01691521）中的日本亚组进行事后分析。年龄≥12岁的重度嗜酸性粒细胞性哮喘患者每4周接受一次静脉注射（IV）75mg美泊利珠单抗、皮下注射（SC）100mg美泊利珠单抗或安慰剂，共32周。主要终点是年化加重率。次要终点和其他终点包括需要急诊就诊/住院的年化加重率、晨起呼气峰值流速（PEF）、圣乔治呼吸问卷（SGRQ）评分和嗜酸性粒细胞计数。监测不良事件（AE）。
在日本亚组（N = 50）中，与安慰剂相比，静脉注射美泊利珠单抗使具有临床意义的加重率降低了90%（率比[RR]：0.10；95%置信区间[CI]：0.02 - 0.57；P = 0.010），皮下注射美泊利珠单抗使加重率降低了62%（RR：0.38；95% CI：0.12 - 1.18；P = 0.094）。静脉注射美泊利珠单抗未报告需要急诊就诊/住院的加重事件；与安慰剂相比，皮下注射美泊利珠单抗使加重事件减少了73%（RR：0.27；95% CI：0.06 - 1.29；P = 0.102）。与安慰剂相比，静脉注射和美泊利珠单抗皮下注射使晨起PEF较基线数值上分别增加了40L/min和13L/min，生活质量改善超过最小临床重要差异（SGRQ：分别为9.5[P = 0.083]和7.9[P = 0.171]分），并降低了嗜酸性粒细胞计数。各治疗组之间AE发生率相似。结果与总体人群大致一致。
美泊利珠单抗在日本重度嗜酸性粒细胞性哮喘患者中有效且耐受性良好，与MENSA总体人群产生相似的反应。
