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首页> 外文期刊>The journal of asthma >Longitudinal changes in asthma control with omalizumab: 2-year interim data from the EXCELS study
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Longitudinal changes in asthma control with omalizumab: 2-year interim data from the EXCELS study

机译：奥马珠单抗控制哮喘的纵向变化：EXCELS研究的2年中期数据

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Background. Asthma guidelines emphasize the importance of achieving and maintaining asthma control; however, many patients with moderate to severe asthma fail to achieve adequate control. Objective. This 2-year interim analysis evaluated the longitudinal effects of omalizumab on asthma control in patients treated in real-world clinical practice settings. Methods. EXCELS is an ongoing observational cohort study of approximately 5000 omalizumab-treated and 2500 non-omalizumab-treated patients aged ≥12 years with moderate to severe asthma. Asthma control was measured using the Asthma Control Test (ACT) every 6 months. Results. Subgroups of the omalizumab cohort included those who initiated omalizumab at baseline (new starts, n 549) and those treated with omalizumab >7 days before baseline (established users, n = 4421). For reference, data are also presented for patients who were not receiving omalizumab prior to or at the time of enrolment (non-omalizumab, n = 2867). Over half of the new starts (54%) achieved improvement in ACT consistent with the minimally important difference (MID, defined as ≥3-point improvement) by Month 6 and this proportion increased throughout the follow-up period, reaching 62% at Month 24. Similar results were observed in patients stratified by moderate and severe asthma. Established users of omalizumab maintained asthma control throughout the observation period. Conclusion. Over a 2-year period, patients initiating omalizumab therapy experienced clinically relevant improvements in asthma control, which were maintained during 2 years of longitudinal follow-up. Established users of omalizumab maintained asthma control over the 2-year period with a small improvement similar to that seen in non-omalizumab users.
机译：背景。哮喘指南强调了实现和维持哮喘控制的重要性;但是，许多中度至重度哮喘患者无法获得足够的控制。目的。这项为期2年的中期分析评估了在实际临床实践中治疗的患者中奥马珠单抗对哮喘控制的纵向影响。方法。 EXCELS是一项持续的观察性队列研究，研究对象为年龄≥12岁的约5000名奥马珠单抗治疗和2500名非奥马珠单抗治疗的中度至重度哮喘患者。每6个月使用哮喘控制测试（ACT）测量一次哮喘控制。结果。 omalizumab队列的亚组包括那些在基线时开始omalizumab的患者（新开始，n 549）和基线之前> 7天接受omalizumab治疗的患者（已建立的用户，n = 4421）。作为参考，还提供了在入组前或入组时未接受奥马珠单抗的患者的数据（非奥马珠单抗，n = 2867）。到第6个月，超过一半的新开始（54％）达到了ACT的改善，与最低限度的重要差异（MID，定义为≥3分的改善）相符，并且该比例在整个随访期间有所增加，在本月达到62％ 24.在中度和重度哮喘分层患者中观察到了相似的结果。 omalizumab的既定使用者在整个观察期内保持哮喘控制。结论。在2年的时间里，开始使用奥马珠单抗治疗的患者在哮喘控制方面经历了临床相关的改善，在纵向随访的2年中一直保持这种改善。已有的奥马珠单抗使用者在2年内保持了哮喘控制，与非奥马珠单抗使用者相似，略有改善。

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