North Shore Medical Arts LLP, Great Neck, New York, and Albert Einstein College of Medicine, Bronx, New York 11021, USA.
Ann Allergy Asthma Immunol. 2010 Dec;105(6):465-70. doi: 10.1016/j.anai.2010.09.011.
Asthma guidelines advocate maintaining asthma control while minimizing corticosteroid exposure.
To assess the reduction in corticosteroid burden during long-term treatment and the corresponding impact of this reduction on asthma control, lung function, and inflammation in patients with moderate to severe allergic asthma.
We conducted a pooled analysis (N = 1,071) of 2 similarly designed, randomized, double-blind, placebo-controlled omalizumab trials and their extension phases. Each study included a 16-week steroid-stable phase, a 12-week steroid-reduction phase, and a 24-week extension phase. Patients received subcutaneous omalizumab (minimum, 0.016 mg/kg/IU (IgE/mL) every 4 weeks) or placebo every 2 or 4 weeks. Outcomes included change from baseline in inhaled corticosteroid dose, number of oral corticosteroid bursts, and other clinical measures, including asthma exacerbations and change in asthma quality-of-life score (questionnaire), lung function, and eosinophil count.
The median reduction from baseline in inhaled corticosteroid dose (beclomethasone dipropionate equivalent dose) by the completion of the extension phase was greater for the omalizumab group than for the placebo group (-420.0 vs -252.0 μg/d; P < .001). During that time, omalizumab-treated patients required fewer oral corticosteroid bursts overall for treatment of acute exacerbations (mean, 0.2 vs 0.3; relative risk, 0.56; 95% confidence interval, 0.41 to 0.76; P < .001) and demonstrated greater improvements in measures of asthma control.
The addition of omalizumab to baseline therapy in patients 12 years or older with moderate to severe persistent allergic asthma resulted in a durable reduction in the overall steroid burden and improvement in other clinical measures of asthma control.
哮喘指南主张在最小化皮质类固醇暴露的同时维持哮喘控制。
评估中重度过敏性哮喘患者在长期治疗中皮质类固醇负担的减少及其对哮喘控制、肺功能和炎症的相应影响。
我们对两项类似设计、随机、双盲、安慰剂对照奥马珠单抗试验及其扩展阶段进行了汇总分析（N=1071）。每个研究包括 16 周的类固醇稳定期、12 周的类固醇减量期和 24 周的扩展期。患者接受皮下奥马珠单抗（最低剂量，0.016 mg/kg/IU（IgE/mL）每 4 周一次）或安慰剂每 2 或 4 周一次。结局包括从基线开始吸入皮质类固醇剂量、口服皮质类固醇爆发次数以及其他临床指标（哮喘恶化和哮喘生活质量评分（问卷）、肺功能和嗜酸性粒细胞计数）的变化。
扩展阶段结束时，奥马珠单抗组比安慰剂组从基线开始吸入皮质类固醇剂量（丙酸倍氯米松等效剂量）的中位数减少更大（-420.0 与-252.0 μg/d；P<0.001）。在此期间，奥马珠单抗治疗患者总体上需要更少的口服皮质类固醇治疗急性发作（平均，0.2 与 0.3；相对风险，0.56；95%置信区间，0.41 至 0.76；P<0.001），并且在哮喘控制的衡量指标方面表现出更大的改善。
在 12 岁及以上中重度持续性过敏性哮喘患者中，奥马珠单抗联合基础治疗可持久降低总体类固醇负担，并改善其他哮喘控制的临床指标。
