A 26-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Effect of Omalizumab on Asthma Control in Patients with Persistent Allergic Asthma
A 26-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Effect of Omalizumab on Asthma Control in Patients with Persistent Allergic Asthma
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DOI：
10.3109/02770903.2011.648296
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发表时间：
2012-03-01
影响因子：
1.9
通讯作者：
Meng, Xiangyi
中科院分区：
文献类型：
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作者：
Bardelas, Jose;Figliomeni, Maria;Meng, Xiangyi
Objective. 2007年国家心肺血液研究所（NHLBI）哮喘指南将治疗重点从哮喘严重程度转移到使用损伤和风险成分进行哮喘控制评估。我们评估了奥马珠单抗对NHLBI第4步或以上哮喘治疗控制不佳的持续性过敏性哮喘患者的哮喘控制效果。方法.在这项双盲、安慰剂对照研究中，年龄≥ 12岁的患者（n = 271）接受奥马珠单抗（n = 136）或安慰剂（n = 135）治疗，每2或4周一次，持续24周。在第24周评价主要疗效变量、哮喘控制试验（ACT）总评分较基线的变化和研究者的治疗有效性总体评价（IGETE，次要疗效变量）。结果与安慰剂相比，奥马珠单抗组ACT评分改善更多（最小二乘均值[LSM]：5.01，4.36）;然而，差异不显著（p = 1779）。同样，IGETE也没有显著差异（p = 1177），但与安慰剂组（19/131，15%）相比，奥马珠单抗组（26/127，20%）有更多患者的IGETE被评为“极好”。“在一个哮喘控制非常差（ACT）的患者亚组中，与安慰剂相比，奥马珠单抗在第24周ACT评分（LSM：6.66，5.27; p = 0.334）和IGETE（p = 0.321）的变化方面观察到了显著的益处
Objective. The 2007 National Heart, Lung, and Blood Institute (NHLBI) asthma guidelines shifted the focus of care from asthma severity to ongoing assessment of asthma control using the components of impairment and risk. We evaluated the effect of omalizumab on asthma control in patients with persistent allergic asthma inadequately controlled with NHLBI Step 4 or above asthma therapy. Methods. In this double-blind, placebo-controlled study, patients >= 12 years (n = 271) received omalizumab (n = 136) or placebo (n = 135) every 2 or 4 weeks for 24 weeks. The primary efficacy variable, change from baseline in Asthma Control Test (ACT) total score, and Investigator's Global Evaluation of Treatment Effectiveness (IGETE, secondary efficacy variable) were evaluated at week 24. Results. ACT score improved more with omalizumab compared with placebo (least squares means [LSMs]: 5.01, 4.36); however, the difference was not significant (p = 1779). Similarly, IGETE was not significantly different (p = 1177), but more patients treated with omalizumab (26/127, 20%) compared with placebo (19/131, 15%) had IGETE rated as "Excellent." Significant benefits were observed for omalizumab compared with placebo for change in ACT score (LSMs: 6.66, 5.27; p = 0334) and IGETE (p = 0321) at week 24 in a subgroup of patients with very poorly controlled asthma (ACT