Snelder S M, Weersink E J M, Braunstahl G J
Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM Rotterdam, The Netherlands.
Academisch Medisch Centrum, Amsterdam, The Netherlands.
Allergy Asthma Clin Immunol. 2017 Jul 26;13:34. doi: 10.1186/s13223-017-0206-9. eCollection 2017.
Omalizumab is licensed as add-on therapy for patients with severe allergic asthma. Response is in most studies scored by the physician's global evaluation of treatment effectiveness (GETE). A good clinical and validated parameter for treatment response is currently missing. Also, there are no established criteria for identifying patients who will respond to omalizumab based on pre-treatment characteristics. The Dutch National Omalizumab in Asthma Registry was developed in 2011 to better evaluate inclusion criteria and measure treatment response after 4 months.
This is a "real world" prospectively designed, observational data registry in which the outcomes of patients who received omalizumab between 2012 and 2015 were evaluated. Data were collected from all centers in the Netherlands comprising demographic features, criteria for starting treatment, GETE, FEV1, oral corticosteroid use and ACQ.
65.5% of the 403 patients had a good or excellent response to omalizumab after 16 weeks according to the treating physician GETE. 64.5% fulfilled all the criteria for prescribing omalizumab at baseline. The mean ACQ improved from 2.96 at baseline to 1.83 at 16 weeks (p < 0.001). 75.3% of the responders showed more than 0.5 points improvement in the ACQ. The mean FEV1 increased from 71.58 to 79.06 (p < 0.001). There was no relationship between patients with a FEV1 <80 and ≥80% at baseline and response (p = 0.981). Most of the responders had a considerable improvement of FEV1 either/or ACQ or OCS use (88.3%). While 86.7% of the responders had an improvement of either ACQ or FEV1. 75.4% of the responders had an improvement of ACQ, while 50.4% had an improvement of FEV1. Finally 11.7% of the patients with no improvement of FEV1, ACQ or OCS use were considered to have a good response.
This registry of 403 inadequately controlled severe allergic asthma patients in the Netherlands showed a good or excellent response of 65.5% to omalizumab after 16 weeks, in accordance with previous studies. The assumption that careful registration would lead to higher response rates could not be supported by the data from this registry. Improvement of ACQ appears to be a useful additional assessment tool to measure response in omalizumab treated patients.
奥马珠单抗被许可作为重度过敏性哮喘患者的附加治疗药物。在大多数研究中，治疗反应通过医生对治疗效果的整体评估（GETE）来评分。目前缺少一个良好的、经过验证的治疗反应参数。此外，尚无基于治疗前特征来识别对奥马珠单抗有反应的患者的既定标准。荷兰国家哮喘奥马珠单抗注册中心于2011年设立，以更好地评估纳入标准并衡量4个月后的治疗反应。
这是一项前瞻性设计的“真实世界”观察性数据注册研究，对2012年至2015年间接受奥马珠单抗治疗的患者的结局进行评估。从荷兰所有中心收集数据，包括人口统计学特征、开始治疗的标准、GETE、第一秒用力呼气容积（FEV1）、口服糖皮质激素的使用情况和哮喘控制问卷（ACQ）。
根据治疗医生的GETE评估，403例患者中有65.5%在16周后对奥马珠单抗有良好或极佳反应。64.5%的患者在基线时符合所有开具奥马珠单抗的标准。ACQ均值从基线时的2.96改善至16周时的1.83（p<0.001）。75.3%的有反应者ACQ改善超过0.5分。FEV1均值从71.58升至79.06（p<0.001）。基线时FEV1<80%和≥80%的患者与反应之间无关联（p = 0.981）。大多数有反应者的FEV1、ACQ或口服糖皮质激素的使用有显著改善（88.3%）。而86.7%的有反应者的ACQ或FEV1有改善。75.4%的有反应者的ACQ有改善，50.4%的有反应者的FEV1有改善。最后，11.7%的FEV1、ACQ或口服糖皮质激素使用无改善的患者被认为有良好反应。
这项对荷兰403例控制不佳的重度过敏性哮喘患者的注册研究显示，16周后65.5%的患者对奥马珠单抗有良好或极佳反应，与先前研究一致。该注册研究的数据无法支持仔细记录会导致更高反应率这一假设。ACQ的改善似乎是衡量奥马珠单抗治疗患者反应的一个有用的附加评估工具。
