Genentech, Inc, South San Francisco, CA.
Genentech, Inc, South San Francisco, CA.
Chest. 2012 Jan;141(1):58-65. doi: 10.1378/chest.11-0020. Epub 2011 Sep 1.
The severity of asthma (SOA) score is based on a validated disease-specific questionnaire that addresses frequency of asthma symptoms, use of systemic corticosteroids, use of other asthma medications, and history of hospitalization/intubation for asthma. SOA does not require measurements of pulmonary function. This study compared the ability of SOA to predict clinical outcomes in the EXCELS (Epidemiological Study of Xolair [omalizumab]: Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate to Severe Asthma) patient population vs three other asthma assessment tools. EXCELS is a large, ongoing, observational study of patients with moderate to severe persistent asthma and reactivity to perennial aeroallergens.
Baseline scores for SOA, asthma control test (ACT), work productivity and impairment index-asthma (WPAI-A), and FEV(1) % predicted were compared for their ability to predict five prespecified adverse clinical outcomes in asthma: serious adverse events (SAEs) reported as exacerbations, SAEs leading to hospitalizations, the incidence of unscheduled office visits, ED visits, and po or IV corticosteroid bursts related to asthma. Logistic regression analysis, area under receiver operating characteristic curves (AUCROCs), and classification and regression tree (CART) analysis were used to evaluate the ability of the four tools to predict adverse clinical outcomes using baseline and 1-year data from 2,878 patients enrolled in the non-omalizumab cohort of EXCELS.
SOA was the only assessment tool contributing significantly in all five statistical models of adverse clinical outcomes by logistic regression analysis (full model AUCROC range, 0.689-0.783). SOA appeared to be a stand-alone predictor for four of five outcomes (reduced model AUCROC range, 0.689-0.773). CART analysis showed that SOA had the greatest variable importance for all five outcomes.
SOA score was a powerful predictor of adverse clinical outcomes in moderate to severe asthma, as evaluated by either logistic regression analysis or CART analysis.
ClinicalTrials.gov; No.: NCT00252135; URL: www.clinicaltrials.gov.
哮喘严重程度（SOA）评分基于经过验证的疾病特异性问卷，该问卷涉及哮喘症状的频率、全身皮质类固醇的使用、其他哮喘药物的使用以及因哮喘住院/插管的病史。SOA 不需要测量肺功能。本研究比较了 SOA 在 EXCELS（奥马珠单抗的流行病学研究：评估中重度哮喘患者的临床疗效和长期安全性）患者人群中的预测临床结局的能力与其他三种哮喘评估工具。EXCELS 是一项正在进行的大型观察性研究，涉及中重度持续性哮喘患者和对常年吸入性过敏原的反应性。
比较 SOA、哮喘控制测试（ACT）、工作效率和哮喘损害指数（WPAI-A）以及 FEV1%预计值的基线评分，以评估它们预测哮喘五种预先指定的不良临床结局的能力：报告为恶化的严重不良事件（SAE）、导致住院的 SAE、无计划就诊的发生率、急诊就诊和与哮喘相关的糖皮质激素冲击治疗较差或静脉。使用来自 EXCELS 非奥马珠单抗队列的 2878 名患者的基线和 1 年数据，进行逻辑回归分析、受试者工作特征曲线下面积（AUROC）、分类和回归树（CART）分析，评估四种工具预测不良临床结局的能力。
SOA 是逻辑回归分析中所有五个不良临床结局统计模型中唯一有显著贡献的评估工具（完整模型 AUROC 范围为 0.689-0.783）。SOA 似乎是五个结局中的四个结局的独立预测因子（简化模型 AUROC 范围为 0.689-0.773）。CART 分析表明，SOA 对所有五个结局的变量重要性最大。
SOA 评分是中重度哮喘不良临床结局的有力预测指标，无论是通过逻辑回归分析还是 CART 分析评估。
ClinicalTrials.gov；编号：NCT00252135；网址：www.clinicaltrials.gov。
