Eisner Mark D, Zazzali James L, Miller Mary K, Bradley Mary S, Schatz Michael
Product Development, Inflammation & Respiratory, Genentech Inc. 1 DNA Way, South San Francisco, CA 94080, USA.
J Asthma. 2012 Aug;49(6):642-8. doi: 10.3109/02770903.2012.690477.
Asthma guidelines emphasize the importance of achieving and maintaining asthma control; however, many patients with moderate to severe asthma fail to achieve adequate control.
This 2-year interim analysis evaluated the longitudinal effects of omalizumab on asthma control in patients treated in real-world clinical practice settings.
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.
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.
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.
哮喘指南强调实现并维持哮喘控制的重要性；然而，许多中重度哮喘患者未能实现充分控制。
这项为期2年的中期分析评估了奥马珠单抗在实际临床实践环境中治疗的患者对哮喘控制的长期影响。
EXCELS是一项正在进行的观察性队列研究，纳入了约5000例接受奥马珠单抗治疗和2500例未接受奥马珠单抗治疗的12岁及以上中重度哮喘患者。每6个月使用哮喘控制测试（ACT）评估哮喘控制情况。
奥马珠单抗队列的亚组包括在基线时开始使用奥马珠单抗的患者（新使用者，n = 549）和在基线前7天以上接受奥马珠单抗治疗的患者（既往使用者，n = 4421）。作为对照，还提供了在入组前或入组时未接受奥马珠单抗治疗的患者的数据（非奥马珠单抗组，n = 2867）。超过一半的新使用者（54%）在第6个月时ACT改善符合最小重要差异（MID，定义为改善≥3分），并且这一比例在整个随访期间不断增加，在第24个月时达到62%。在按中度和重度哮喘分层的患者中也观察到了类似结果。奥马珠单抗的既往使用者在整个观察期内维持了哮喘控制。
在2年期间，开始使用奥马珠单抗治疗的患者在哮喘控制方面有临床相关改善，并在2年的纵向随访中得以维持。奥马珠单抗的既往使用者在2年期间维持了哮喘控制，有与未使用奥马珠单抗的使用者类似的小幅改善。
