Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.
Int Arch Allergy Immunol. 2012;159(1):83-93. doi: 10.1159/000335382. Epub 2012 May 4.
It is unclear how far the superior efficacy of omalizumab, established in randomized controlled clinical trials of patients with severe allergic asthma (SAA), translates into routine practice and when compared to matched controls.
New-onset omalizumab-treated (OT) patients with SAA (n = 53) were compared to a matched control group of usual-care (UC) patients (n = 53). Treatment and procedures were naturalistic. Subsequent to a baseline assessment, patients were followed up over at least 6 months with at least two follow-up assessments. Primary clinical outcomes were the number of asthma attacks, persistence of asthma symptoms and degree of control [asthma control test (ACT), Global Initiative for Asthma]. Secondary outcome criteria were quality of life (Euro-Qol 5D) and number of medications. For each outcome we compared within-group effects from baseline to 6-month follow-up as well as between-group effects.
OT patients showed significant improvements in number [effect size (ES) = 0.03] and frequency (ES = 0.04) of asthma attacks as well as asthma control (ES = 0.09), whereas controls revealed no significant improvements in these measures. Further improvements in the OT group were found for 'perceived control always' (ACT, p = 0.006), no impairment (ACT, p = 0.02), reduction of sickness days (p = 0.002) and number of medications needed (p = 0.001).
Substantial beneficial effects of omalizumab, similar to those observed in controlled trials and after marketing studies, were confirmed, particularly with regard to the reduction of asthma attacks, persistence of symptoms, asthma control and reduction of concomitant asthma medications. This study provides a tougher test and generalizable evidence for the effectiveness of omalizumab in routine care.
在重度过敏性哮喘（SAA）患者的随机对照临床试验中，奥马珠单抗的卓越疗效如何转化为常规实践，以及与匹配对照组相比如何，目前尚不清楚。
新诊断为奥马珠单抗治疗（OT）的 SAA 患者（n=53）与常规护理（UC）患者的匹配对照组（n=53）进行比较。治疗和程序是自然发生的。在基线评估后，患者至少进行了 6 个月的随访，至少进行了两次随访评估。主要临床结局是哮喘发作次数、哮喘症状持续时间和控制程度[哮喘控制测试（ACT）、全球哮喘倡议]。次要结局标准为生活质量（Euro-Qol 5D）和药物使用数量。对于每个结局，我们比较了从基线到 6 个月随访的组内效应以及组间效应。
OT 患者在哮喘发作次数[效应大小（ES）=0.03]和频率（ES=0.04）以及哮喘控制（ES=0.09）方面均有显著改善，而对照组在这些指标上没有显著改善。OT 组在“始终感觉控制良好”（ACT，p=0.006）、无恶化（ACT，p=0.02）、病假天数减少（p=0.002）和所需药物数量减少（p=0.001）方面有进一步改善。
奥马珠单抗的显著有益效果得到了证实，与对照试验和上市后研究观察到的效果相似，特别是在减少哮喘发作、症状持续时间、哮喘控制和减少伴随哮喘药物方面。本研究提供了对奥马珠单抗在常规护理中的有效性更严格的测试和更具普遍性的证据。
