Vaník Petr, Novosad Jakub, Kirchnerová Olga, Krčmová Irena, Teřl Milan
Department of Respiratory Diseases, B. Němcové 54, Hospital České Budějovice, a.s., Faculty of Medicine in Pilsen, Charles University, 37001 Prague, Czech Republic.
Institute of Clinical Immunology and Allergy, University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.
Allergy Asthma Clin Immunol. 2020 Sep 15;16:81. doi: 10.1186/s13223-020-00479-1. eCollection 2020.
Omalizumab is an efficient drug for patients with uncontrolled severe allergic asthma (SAA). However, little is known about the differences in omalizumab treatment outcomes among patients with different types of atopic sensitization. Here, we assessed the effect of sensitization to individual allergens or their combinations on the outcomes of anti-IgE therapy in patients with SAA.
We performed a post hoc analysis of data of subgroups of patients enrolled in the Czech Anti-IgE Registry (CAR). The patients were evaluated at baseline and 16 weeks and 12 months after omalizumab treatment initiation. We analyzed the dependence of primary treatment outcomes [global evaluation of treatment effectiveness (GETE) after 16 weeks of treatment, a reduction in severe exacerbation rate (ER), and an improvement in the asthma control test (ACT) result during 12 months of treatment] and secondary outcomes [a reduction in systemic corticosteroid (SCS) use, an improvement in lung functions, and a fraction of exhaled nitric oxide] of patients with SAA treated with omalizumab for 12 months on sensitization to different perennial aeroallergens. We assessed sensitization to house dust mites, molds, and pets at baseline using skin prick tests and/or specific IgE measurement (semiquantitative evaluation). We compared polysensitized patients (sensitized to all tested allergens) with monosensitized (single positivity) or partially polysensitized patients (combined positivity but not to all allergens).
We enrolled 279 patients (58.3% women, mean age 52.9 years). Omalizumab treatment presented an 82.8% response rate (according to GETE). It significantly reduced severe asthma exacerbations and SCS use, and improved the ACT result in 161 responders. We identified a subgroup of responders with distinct sensitization patterns (polysensitization to all tested perennial allergens) with higher odds of being responders (OR = 2.217, p = 0.02) and lower tendency to improve ACT result (OR 0.398, p = 0.023) and reduce ER (OR 0.431, p = 0.034) than non-polysensitized patients.
The clinical benefit of sensitization for patients with SAA receiving omalizumab may be particularly dependent on sensitization pattern. Polysensitized patients showed a higher tendency to be responders (GETE), but a lower tendency to improve the ACT result and reduce ER than non-polysensitized patients.
奥马珠单抗对重度过敏性哮喘（SAA）控制不佳的患者是一种有效的药物。然而，对于不同类型特应性致敏患者的奥马珠单抗治疗结果差异知之甚少。在此，我们评估了对单一过敏原或其组合的致敏对SAA患者抗IgE治疗结果的影响。
我们对捷克抗IgE注册中心（CAR）登记的患者亚组数据进行了事后分析。在奥马珠单抗治疗开始时、治疗16周和12个月时对患者进行评估。我们分析了SAA患者接受奥马珠单抗治疗12个月的主要治疗结果[治疗16周后的治疗效果总体评估（GETE）、严重加重率（ER）的降低以及治疗12个月期间哮喘控制测试（ACT）结果的改善]和次要结果[全身用皮质类固醇（SCS）使用的减少、肺功能的改善以及呼出一氧化氮分数]对不同常年性气传过敏原致敏的依赖性。我们在基线时使用皮肤点刺试验和/或特异性IgE测量（半定量评估）评估对屋尘螨、霉菌和宠物的致敏情况。我们将多致敏患者（对所有测试过敏原均致敏）与单致敏（单一阳性）或部分多致敏患者（联合阳性但并非对所有过敏原均致敏）进行了比较。
我们纳入了279例患者（58.3%为女性，平均年龄52.9岁）。奥马珠单抗治疗的有效率为82.8%（根据GETE）。它显著降低了严重哮喘发作和SCS的使用，并改善了161例有反应者的ACT结果。我们确定了一组具有独特致敏模式（对所有测试的常年性过敏原均多致敏）的有反应者亚组，与非多致敏患者相比，其成为有反应者的几率更高（OR = 2.217，p = 0.02），改善ACT结果的趋势更低（OR 0.398，p = 0.023），降低ER的趋势更低（OR 0.431，p = 0.034）。
接受奥马珠单抗治疗的SAA患者致敏的临床益处可能特别取决于致敏模式。与非多致敏患者相比，多致敏患者显示出更高的成为有反应者（GETE）的趋势，但改善ACT结果和降低ER的趋势更低。
