为期26周的随机、双盲、安慰剂对照、多中心研究，评价奥玛珠单抗对持续过敏性哮喘患者哮喘控制的影响
2012/02/29
目的：2007年国家心脏、肺和血液研究所(NHLBI)哮喘指南将之前管理焦点从哮喘严重程度转移到采用受损情况和风险实时评价哮喘控制中。本研究在采用NHLBI第4步或以上哮喘治疗仍未得到很好控制的持续过敏性哮喘患者中，评价奥玛珠单抗对哮喘控制的影响。
方法：本项双盲、安慰剂对照研究中，年龄≥12岁的271名患者接受每2周或4周一次的奥玛珠单抗（n = 136）或安慰剂（n = 135）治疗24周。在24周时评价主要有效性变量，即与基础水平相比的哮喘控制测试（ACT）总评分变化值和治疗疗效研究者整体评价（IGETE，次要有效性变量）。
结果：与安慰剂组相比，ACT评分在奥玛珠单抗组改善更明显（最小二乘均数[LSMs]: 5.01, 4.36），但差异无显著性(p =0.1779)。与此类似，两组间的IGETE差异无显著性(p =0.1177) 。但与安慰剂相比(19/131, 15%)，奥玛珠单抗组更多的患者(26/127, 20%) IGETE评价为“优秀”。基础水平下，哮喘控制非常差的患者(ACT ≤ 15)，与安慰剂组相比，奥玛珠单抗组患者的ACT评分(LSMs: 6.66, 5.27; p =0.0334)和IGETE (p =0.0321)在24周时改善更明显。基础水平下第一秒用力呼气体积≤ 80%预测值的患者，上述2个指标在24周时无显著差异。两组患者间不良反应发生率上无显著差异，未见药物相关的严重不良反应和死亡。
结论：对于接受NHLBI第4步或更高级治疗的过敏性哮喘患者，奥玛珠单抗能改善哮喘控制。但与安慰剂相比，差异无显著性。安慰剂治疗的患者ACT评分也显著改善，这使得两组间差异无显著性。亚组分析显示，对于哮喘控制非常差的哮喘患者，与安慰剂组相比，奥玛珠单抗能显著改善患者ACT和IGETE。
（林江涛 审校）
J Asthma. 2012 Jan 25. [Epub ahead of print]
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.
Bardelas J, Figliomeni M, Kianifard F, Meng X.
Source
Allergy and Asthma Center of North Carolina, PA , Greensboro, NC , USA.
Abstract
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 ≤ 15) at baseline. There were no significant differences for the subgroup of patients with forced expiratory volume in 1 second ≤ 80% predicted at baseline. Adverse events (AEs) were similar between groups with no drug-related serious AEs or deaths.
CONCLUSIONS： For allergic asthma patients with NHLBI Step 4 or above asthma therapy, omalizumab consistently improved asthma control; however, compared with placebo, differences were not significant. Placebo-treated patients had substantial improvement in their ACT score, which may have limited the ability to detect differences between treatment groups. Subgroup analyses showed significant improvements with omalizumab versus placebo in patients with very poorly controlled asthma.
J Asthma. 2012 Jan 25. [Epub ahead of print]
方法：本项双盲、安慰剂对照研究中，年龄≥12岁的271名患者接受每2周或4周一次的奥玛珠单抗（n = 136）或安慰剂（n = 135）治疗24周。在24周时评价主要有效性变量，即与基础水平相比的哮喘控制测试（ACT）总评分变化值和治疗疗效研究者整体评价（IGETE，次要有效性变量）。
结果：与安慰剂组相比，ACT评分在奥玛珠单抗组改善更明显（最小二乘均数[LSMs]: 5.01, 4.36），但差异无显著性(p =0.1779)。与此类似，两组间的IGETE差异无显著性(p =0.1177) 。但与安慰剂相比(19/131, 15%)，奥玛珠单抗组更多的患者(26/127, 20%) IGETE评价为“优秀”。基础水平下，哮喘控制非常差的患者(ACT ≤ 15)，与安慰剂组相比，奥玛珠单抗组患者的ACT评分(LSMs: 6.66, 5.27; p =0.0334)和IGETE (p =0.0321)在24周时改善更明显。基础水平下第一秒用力呼气体积≤ 80%预测值的患者，上述2个指标在24周时无显著差异。两组患者间不良反应发生率上无显著差异，未见药物相关的严重不良反应和死亡。
结论：对于接受NHLBI第4步或更高级治疗的过敏性哮喘患者，奥玛珠单抗能改善哮喘控制。但与安慰剂相比，差异无显著性。安慰剂治疗的患者ACT评分也显著改善，这使得两组间差异无显著性。亚组分析显示，对于哮喘控制非常差的哮喘患者，与安慰剂组相比，奥玛珠单抗能显著改善患者ACT和IGETE。
（林江涛 审校）
J Asthma. 2012 Jan 25. [Epub ahead of print]
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.
Bardelas J, Figliomeni M, Kianifard F, Meng X.
Source
Allergy and Asthma Center of North Carolina, PA , Greensboro, NC , USA.
Abstract
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 ≤ 15) at baseline. There were no significant differences for the subgroup of patients with forced expiratory volume in 1 second ≤ 80% predicted at baseline. Adverse events (AEs) were similar between groups with no drug-related serious AEs or deaths.
CONCLUSIONS： For allergic asthma patients with NHLBI Step 4 or above asthma therapy, omalizumab consistently improved asthma control; however, compared with placebo, differences were not significant. Placebo-treated patients had substantial improvement in their ACT score, which may have limited the ability to detect differences between treatment groups. Subgroup analyses showed significant improvements with omalizumab versus placebo in patients with very poorly controlled asthma.
J Asthma. 2012 Jan 25. [Epub ahead of print]
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哮喘成人患者的焦虑敏感性、哮喘控制和生活质量
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哮喘用药指南对哮喘控制用药和哮喘发作率的影响：比较1997～1998与2004～2005的数据
