哮喘联盟

   摘要
   背景：严重持续性过敏性哮喘患者常用口服糖皮质激素（OCS）治疗。虽然OCS治疗有效果，但伴随而来的是一系列的不良反应。eXpeRience量表常用来研究非受控过敏性哮喘患者接受奥马珠单抗的真实结果。我们研究奥马珠单抗治疗对OCS使用的影响。
   方法：eXpeRience是一个对接受奥马珠单抗治疗的非受控过敏性哮喘患者展开的为期2年、多国参与、非干预性的观察性量表。观察基线水平和应用奥马珠单抗后16 周、8个月、12个月、18个月、24个月的OCS使用情况（维持OCS使用的患者比例，每日OCS的平均总量及OCS治疗地位的改变）。在大约16周时，采用内科医生的治疗效果总体评价(GETE)表评估OCS对奥马珠单抗的反应情况。同时收集安全性的数据。
   结果：共943例患者被纳入研究（平均年龄45岁；女性占64.9%），其中263例患者在基线接受维持量的OCS治疗。与基线(28.6%; 意向性分析)相比，使用维持量的奥马珠单抗的第12个月(16.1%)和第24个月(14.2%)的患者比例明显降低。915例接受奥马珠单抗治疗的患者进行GETE评估：64.2%为有反应者（反应优或良），30.7%为无反应者（中等、不良或更差的反应）；5.1% 没有进行评估。严重不良反应的发生率与奥马珠单抗的对照患者相似。
   结论：实际临床中，奥马珠单抗的使用与非受控的持续性过敏性哮喘患者减少OCS的影响有关。

 

（苏楠 审校）
Allergy Asthma Clin Immunol. 2013 Dec 4;9(1):47. [Epub ahead of print]

Reduction in oral corticosteroid use in patients receiving omalizumab for allergic asthma in the real-world setting.

Braunstahl GJ, Chlumský J, Peachey G, Chen CW.

ABSTRACT
BACKGROUND: Oral corticosteroids (OCS) are commonly administered in patients with severe persistent allergic asthma. Despite their efficacy, they are associated with a wide variety of adverse events. The eXpeRience registry was set up to investigate real-world outcomes among patients receiving omalizumab for the treatment of uncontrolled allergic asthma. Here, we present the effect of omalizumab treatment on OCS use.
METHODS: eXpeRience was a 2-year, multinational, non-interventional, observational registry of patients receiving omalizumab for uncontrolled allergic asthma. OCS use (proportion of patients on maintenance OCS, mean total daily OCS dose and change in status of OCS therapy) was assessed at baseline, 16 weeks, and 8, 12, 18, and 24 months after the initiation of omalizumab. Response to omalizumab was assessed using the physician's Global Evaluation of Treatment Effectiveness (GETE) at approximately Week 16. Safety data were also recorded.
RESULTS: A total of 943 patients (mean age, 45 years; female, 64.9%) were enrolled in the registry, 263 of whom were receiving maintenance OCS at baseline. The proportion of patients taking maintenance OCS was markedly lower at Months 12 (16.1%) and 24 (14.2%) than at baseline (28.6%; intent-to-treat population). GETE status was determined in 915 patients receiving omalizumab: 64.2% were responders (excellent or good response), 30.7% were non-responders (moderate, poor or worsening response); 5.1% had no assessment. The frequency of serious adverse events was comparable to that seen in controlled trials of omalizumab.
CONCLUSIONS: Omalizumab use is associated with an OCS-sparing effect in patients with uncontrolled persistent allergic asthma in the real-world setting.
 

Allergy Asthma Clin Immunol. 2013 Dec 4;9(1):47. [Epub ahead of print]