Buhl Roland, Marco Andrea Gili, Cohen Daniel, Canonica Giorgio Walter
Pulmonary Department, University Hospital, Johannes Gutenberg-University, Langenbeckstr, D-55131 Mainz, Germany.
Novartis Pharma AG, 4056 Basel, Switzerland.
Respir Med. 2014 Jan;108(1):50-6. doi: 10.1016/j.rmed.2013.10.026. Epub 2013 Nov 9.
Omalizumab is an add-on therapy for patients with uncontrolled severe allergic asthma. In Europe, patients must fulfil a number of additional criteria to become eligible for omalizumab therapy, creating a challenge for epidemiology studies to quantify the potential patient pool. Thus, and in the absence of robust data, the number of omalizumab-eligible patients has remained unclear. To assess eligible patient numbers, a chart-audit design approach was employed to measure epidemiology variables based on patient-level data. 770 patient charts were reviewed in designated towns in Germany and Italy, in collaboration with >200 primary care physicians (PCPs) and respiratory specialists (RS). This study sample represents >50% and >70% of local RS in these designated towns of Germany and Italy, respectively. Of patient charts evaluated, 4 patients were currently receiving omalizumab. A further 31 patients (12 PCP; 19 RS) were evaluated as omalizumab-eligible (i.e. fulfilled all product label criteria) but were not receiving the drug. Extrapolating to a national level, this yields >6500 eligible patients in Germany, and >3200 in Italy. Furthermore, this study sample revealed a significant number of PCPs treating uncontrolled severe asthma patients without referral to RS; these patients are not consistently evaluated for FEV1, aero-allergen sensitivity, a qualitative understanding of severe exacerbations, and day and night-time symptoms. This study suggests that significant numbers of omalizumab-naïve severe allergic asthma patients in Germany/Italy are eligible for omalizumab therapy. Despite proven benefits in uncontrolled severe allergic asthma, adjunctive omalizumab therapy is underutilized.
奥马珠单抗是用于治疗控制不佳的重度过敏性哮喘患者的附加疗法。在欧洲，患者必须满足多项额外标准才有资格接受奥马珠单抗治疗，这给流行病学研究量化潜在患者群体带来了挑战。因此，在缺乏可靠数据的情况下，符合奥马珠单抗治疗条件的患者数量一直不明确。为了评估符合条件的患者数量，采用了图表审核设计方法，根据患者层面的数据来衡量流行病学变量。在德国和意大利的指定城镇，与200多名初级保健医生（PCP）和呼吸专科医生（RS）合作，对770份患者病历进行了审查。该研究样本分别占德国和意大利这些指定城镇当地RS的50%以上和70%以上。在评估的患者病历中，有4名患者目前正在接受奥马珠单抗治疗。另有31名患者（12名PCP；19名RS）被评估为符合奥马珠单抗治疗条件（即满足所有产品标签标准）但未接受该药物治疗。 extrapolating to a national level, this yields >6500 eligible patients in Germany, and >3200 in Italy.此外，该研究样本显示，有相当数量的初级保健医生在未转诊至呼吸专科医生的情况下治疗控制不佳的重度哮喘患者；这些患者未被持续评估第一秒用力呼气容积、空气过敏原敏感性、对严重加重情况的定性理解以及白天和夜间症状。这项研究表明德国/意大利有相当数量未使用过奥马珠单抗的重度过敏性哮喘患者有资格接受奥马珠单抗治疗。尽管奥马珠单抗在控制不佳的重度过敏性哮喘中已被证明有疗效，但辅助性奥马珠单抗治疗的使用率仍然较低。
