Pelaia Corrado, Crimi Claudia, Benfante Alida, Caiaffa Maria Filomena, Calabrese Cecilia, Carpagnano Giovanna Elisiana, Ciotta Domenico, D'Amato Maria, Macchia Luigi, Nolasco Santi, Pelaia Girolamo, Pellegrino Simona, Scichilone Nicola, Scioscia Giulia, Spadaro Giuseppe, Valenti Giuseppe, Vatrella Alessandro, Crimi Nunzio
Department of Health Sciences, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.
Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.
J Asthma Allergy. 2021 Feb 22;14:163-173. doi: 10.2147/JAA.S297273. eCollection 2021.
Benralizumab can be utilized as add-on biological treatment of severe eosinophilic asthma. However, so far only a few real-life studies have been published with regard to the use of this anti-IL-5 receptor humanized monoclonal antibody.
The primary aim of this multicenter observational investigation has been to assess the therapeutic effects of benralizumab in patients with severe uncontrolled, corticosteroid refractory eosinophilic asthma. The secondary objective was to evaluate the efficacy of benralizumab with regard to positive or negative skin prick test (SPT).
Clinical, functional, and laboratory parameters were evaluated in order to verify the therapeutic actions of benralizumab in atopic and non atopic subjects with difficult-to-treat eosinophilic asthma. Moreover, a comparative evaluation was carried out in relation to the presence or absence of SPT positivity.
After 6 months of add-on biological therapy with benralizumab, our 111 patients experienced a marked improvement of their severe eosinophilic asthma, expressed by significant changes in asthma exacerbation rate, prednisone intake, daily use of short-acting β-adrenergic agonists (SABA), asthma control test (ACT) score, asthma quality of life questionnaire (AQLQ) score (56 patients), forced expiratory volume in one second (FEV), forced vital capacity (FVC), blood eosinophil count, blood basophil count (59 patients), and fractional exhaled nitric oxide (FeNO) levels (39 patients). In addition, significantly more effective outcomes were detected in patients with positive SPT, when compared to subjects with negative SPT, only in regard to asthma exacerbation number, ACT score, and daily SABA utilization. No significant correlation was found between serum IgE concentrations and each of all measured parameters.
Taken together, the results of this real-world study indicate that in both allergic and non-allergic subjects benralizumab can be used as a valuable pharmacotherapeutic option for add-on biological therapy of severe eosinophilic asthma, regardless of SPT positivity or negativity.
贝那利珠单抗可作为重度嗜酸性粒细胞性哮喘的附加生物治疗药物。然而，迄今为止，关于这种抗白细胞介素-5受体人源化单克隆抗体的使用，仅有少数真实病例研究发表。
这项多中心观察性研究的主要目的是评估贝那利珠单抗对重度未控制、皮质类固醇难治性嗜酸性粒细胞性哮喘患者的治疗效果。次要目的是评估贝那利珠单抗在皮肤点刺试验（SPT）呈阳性或阴性患者中的疗效。
对临床、功能和实验室参数进行评估，以验证贝那利珠单抗在治疗难治性嗜酸性粒细胞性哮喘的特应性和非特应性受试者中的治疗作用。此外，针对SPT阳性与否进行了对比评估。
在接受贝那利珠单抗附加生物治疗6个月后，我们的111例患者的重度嗜酸性粒细胞性哮喘有显著改善，表现为哮喘加重率、泼尼松摄入量、短效β-肾上腺素能激动剂（SABA）每日使用量、哮喘控制测试（ACT）评分、哮喘生活质量问卷（AQLQ）评分（56例患者）、一秒用力呼气容积（FEV）、用力肺活量（FVC）、血液嗜酸性粒细胞计数、血液嗜碱性粒细胞计数（59例患者）和呼出一氧化氮分数（FeNO）水平（39例患者）的显著变化。此外，与SPT阴性的受试者相比，仅在哮喘加重次数、ACT评分和SABA每日使用量方面，SPT阳性的患者检测到更有效的结果。血清IgE浓度与所有测量参数之间均未发现显著相关性。
综上所述，这项真实世界研究的结果表明，无论SPT阳性或阴性，在过敏性和非过敏性受试者中，贝那利珠单抗均可作为重度嗜酸性粒细胞性哮喘附加生物治疗的一种有价值的药物治疗选择。
