Department of Drug Sciences, University of Pavia, Via G. Previati 74 20149 Milano c/o S.A.V.E., Pavia, Italy.
S.A.V.E. Studi Analisi Valutazioni Economiche S.r.l., Health Economics & Outcomes Research, Milan, Italy.
Ther Adv Respir Dis. 2019 Jan-Dec;13:1753466619841350. doi: 10.1177/1753466619841350.
Asthma is a highly prevalent chronic inflammatory airways disease, with a considerable impact on quality of life (QoL). To express the effects of asthma on patients' subjective experience, patient-reported outcomes (PROs) represent an important instrument. The asthma QoL questionnaire (AQLQ) is one of the main PROs among these.
To identify long-term asthma-related QoL outcomes associated with omalizumab therapy in patients with moderate-to-severe asthma, we developed a systematic review according to the PRISMA guidelines. Published real-world effectiveness studies of adults or adolescents (12 years or older) with moderate-to-severe allergic asthma treated with omalizumab for at least 48 weeks were reviewed. Sources used were Medline ( PubMed), the Cochrane Library and Google Scholar up to February 2018. In addition, a cross-referencing search was conducted to complete the revision.
A total of 255 potential papers were identified in the first search through the database. After full-text viewing, eight articles were finally included in the review. We summarized the results according to the study design, patient baseline characteristics and effectiveness outcomes assessed by AQLQ score results: variation from baseline to the end of study. Results confirmed the long-term benefits of omalizumab as an add-on therapy in patients with uncontrolled moderate-to-severe allergic asthma. Since there is a lot of evidence on omalizumab effectiveness, we aimed to focus on how a therapy can change patient's QoL in a long time period. Data showed long-term effects of omalizumab treatment on subjective (PROs) and objective (lung function, corticosteroid use, hospitalizations, asthma exacerbation) effectiveness measures.
Studies included in our review were observational trials that, due to their design, present a potential risk of selection bias in the patients included. Beyond this limit, the evaluation of QoL using the AQLQ showed a clear increase over time, following both 48 weeks and 9 years of observation, where QoL improvements still were significant over baseline values.
哮喘是一种高发的慢性炎症性气道疾病,对生活质量(QoL)有很大影响。为了表达哮喘对患者主观体验的影响,患者报告的结果(PROs)是一个重要的工具。哮喘生活质量问卷(AQLQ)是其中主要的 PRO 之一。
为了确定奥马珠单抗治疗中重度哮喘患者与哮喘相关的长期生活质量结局,我们根据 PRISMA 指南制定了系统评价。对至少接受奥马珠单抗治疗 48 周的中重度过敏性哮喘成人或青少年(12 岁及以上)的真实世界疗效研究进行了综述。使用的资源包括 Medline(PubMed)、Cochrane 图书馆和 Google Scholar,检索时间截至 2018 年 2 月。此外,还进行了交叉引用搜索以完成综述。
通过数据库首次搜索共确定了 255 篇潜在论文。经过全文阅读,最终有 8 篇文章被纳入综述。我们根据研究设计、患者基线特征和 AQLQ 评分结果评估的疗效结局总结了结果:从基线到研究结束的变化。结果证实了奥马珠单抗作为附加疗法治疗未控制的中重度过敏性哮喘的长期益处。由于奥马珠单抗有效性的证据很多,我们旨在重点关注一种治疗方法如何在长时间内改变患者的生活质量。数据显示奥马珠单抗治疗对主观(PROs)和客观(肺功能、皮质类固醇使用、住院、哮喘恶化)疗效测量的长期影响。
纳入我们综述的研究是观察性试验,由于其设计,纳入的患者存在选择偏倚的潜在风险。除了这一限制之外,使用 AQLQ 评估生活质量显示出随着时间的推移呈明显增加趋势,在观察 48 周和 9 年后,生活质量改善仍显著高于基线值。