Omalizumab Effectiveness by Biomarker Status in Patients with Asthma: Evidence From PROSPERO, A Prospective Real-World Study
Omalizumab Effectiveness by Biomarker Status in Patients with Asthma: Evidence From PROSPERO, A Prospective Real-World Study
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DOI：
10.1016/j.jaip.2018.04.043
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发表时间：
2019-01-01
影响因子：
9.4
通讯作者：
Chipps, Bradley E.
中科院分区：
文献类型：
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作者：
Casale, Thomas B.;Luskin, Allan T.;Chipps, Bradley E.
背景技术背景：奥马珠单抗已在哮喘患者的临床试验中证明了疗效，但需要真实世界的数据。目的：评估奥马珠单抗在真实世界环境中开始治疗哮喘患者后的结局。方法：根据医生评估的需要，年龄在12岁及以上的过敏性哮喘患者是奥马珠单抗的候选者，他们被纳入一项基于美国的前瞻性、单臂、48周多中心研究，前瞻性观察性研究，以评估奥马珠单抗临床有效性的预测因素。每月评估包括急性加重、医疗保健利用、哮喘控制试验（ACT）和不良事件。在基线，6个月，和研究结束时，生物标志物（血嗜酸性粒细胞和呼出的一氧化氮分数）收集和肺功能performed.Results：806 enrollees，801（99.4%）收到omalizumab和622（77.2%）完成了研究。急性加重率从基线前12个月的平均3.00-3.28显著改善至12个月的0.78-1.37（P
BACKGROUND: Omalizumab has demonstrated efficacy in clinical trials of patients with asthma, but real-world data are needed.OBJECTIVE: To assess outcomes after omalizumab initiation in patients with asthma in a real-world setting.METHODS: Patients aged 12 years and older with allergic asthma who were candidates for omalizumab on the basis of physician-assessed need were enrolled in a US-based, prospective, single-arm, 48-week multicenter study, the Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab. Monthly assessments included exacerbations, health care utilization, asthma control test (ACT), and adverse events. At baseline, 6 months, and end of study, biomarkers (blood eosinophils and fractional exhaled nitric oxide) were collected and spirometry performed.RESULTS: Of 806 enrollees, 801 (99.4%) received omalizumab and 622 (77.2%) completed the study. The exacerbation rate significantly improved from a mean of 3.00-3.28 in the 12 months before baseline to 0.78-1.37 through month 12 (P