Bhutani Mohit, Yang William H, Hébert Jacques, de Takacsy Frederica, Stril Jean-Louis
Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Ottawa Allergy Research Corporation, University of Ottawa, Ottawa, Ontario, Canada.
PLoS One. 2017 Aug 31;12(8):e0183869. doi: 10.1371/journal.pone.0183869. eCollection 2017.
Omalizumab is a non-steroidal medication indicated for the treatment of poorly controlled moderate-to-severe allergic asthmatics. This observational study examines the "real world" effectiveness of omalizumab in this population.
This is a one year open-label observational study that compared clinical outcomes including total oral corticosteroid use, exacerbation history, measures of quality of life and inflammation in patients with moderate-to-severe allergic asthma, who were prescribed omalizumab as part of their treatment with the year prior to therapy.
A total of 99 patients were enrolled at 25 sites in Canada. During the study period, the mean total annual OCS dose was reduced from 2301.5 mg (prednisone equivalents) in the year prior to omalizumab to 1130.0 mg (p<0.0001). There was a 71% reduction in asthma exacerbations and 56% of patients on omalizumab remained exacerbation free when compared to the year prior to study entry. Associated with this was reduced health care utilization. There were significant improvements in the Asthma Control Questionnaire (ACQ) and Asthma Quality of Life questionnaire (AQLQ) Patients with an elevated FeNO at baseline showed a better response to treatment. No new safety issues were identified during the study period.
Our study demonstrates that in "real world" clinical practice, after initiating omalizumab, there is a reduction in total OCS use and exacerbation frequency in patients with moderate-to-severe allergic asthma. Patients on treatment reported improved asthma control and quality of life. FeNO may be a useful biomarker to identify patients who may benefit with omalizumab treatment.
奥马珠单抗是一种非甾体类药物，用于治疗控制不佳的中重度过敏性哮喘患者。本观察性研究考察了奥马珠单抗在该人群中的“真实世界”疗效。
这是一项为期一年的开放标签观察性研究，比较了中重度过敏性哮喘患者的临床结局，包括口服糖皮质激素的总使用量、加重病史、生活质量指标和炎症情况，这些患者在治疗前一年已将奥马珠单抗作为治疗的一部分进行了处方。
加拿大25个地点共纳入了99例患者。在研究期间，奥马珠单抗治疗前一年的平均年度口服糖皮质激素总剂量从2301.5毫克（泼尼松等效剂量）降至1130.0毫克（p<0.0001）。与研究入组前一年相比，哮喘加重次数减少了71%，接受奥马珠单抗治疗的患者中有56%未出现加重情况。与此相关的是医疗保健利用率降低。哮喘控制问卷（ACQ）和哮喘生活质量问卷（AQLQ）有显著改善。基线时呼出一氧化氮（FeNO）升高的患者对治疗反应更好。研究期间未发现新的安全问题。
我们的研究表明，在“真实世界”的临床实践中，开始使用奥马珠单抗后，中重度过敏性哮喘患者的口服糖皮质激素总使用量和加重频率降低。接受治疗的患者报告哮喘控制和生活质量有所改善。FeNO可能是一种有用的生物标志物，可用于识别可能从奥马珠单抗治疗中获益的患者。
