Izumo Takehiro, Tone Mari, Kuse Naoyuki, Awano Nobuyasu, Tanaka Atsuko, Jo Tatsunori, Yoshimura Hanako, Minami Jonsu, Takada Kohei, Inomata Minoru
Department of Respiratory Medicine, Japanese Red Cross Medical Center, Tokyo, Japan.
Ann Transl Med. 2020 Apr;8(7):438. doi: 10.21037/atm.2020.04.01.
Benralizumab is a humanized, fucosylated, monoclonal antibody that targets the interleukin 5 (IL-5) α receptor. Several phase III trials have shown that benralizumab can significantly reduce the incidence of acute exacerbations and improve lung function in patients with severe asthma. However, there is a paucity of data from clinical practice. In this prospective study, we evaluated the effectiveness and safety of benralizumab for severe asthma in clinical practice.
This was a prospective, open-label, single-arm, single-center study in patients with severe asthma in clinical practice (UMIN000031951). Haematological, clinical, functional, and pharmacotherapeutic parameters were evaluated at baseline and at weeks 4 and 12 after initiation of benralizumab.
Twenty-six patients were enrolled between May 2018 and March 2019. Both asthma quality of life questionnaire (AQLQ) score and asthma control test (ACT) score showed significant improvement over the study period. Forced expiratory volume in 1.0 second (FEV1) showed a significant increase at week 12 (baseline: 1.57 L; week 12: 1.75 L). Blood eosinophil and basophil counts were significantly decreased at week 12 compared to baseline. At week 12, the dose of regular oral corticosteroids (OCS) was significantly decreased from baseline as was the number of patients on need-based OCS. Benralizumab had no significant effect on fractional exhaled nitric oxide (FeNO) levels and total immunoglobulin E levels. Only one patient experienced mild headache during benralizumab therapy.
In this study, benralizumab conferred clinically significant benefits in patients with severe asthma with no short-term severe adverse events.
贝那利珠单抗是一种人源化、岩藻糖基化的单克隆抗体，靶向白细胞介素5（IL-5）α受体。多项III期试验表明，贝那利珠单抗可显著降低重度哮喘患者急性加重的发生率并改善肺功能。然而，临床实践中的数据较少。在这项前瞻性研究中，我们评估了贝那利珠单抗在临床实践中治疗重度哮喘的有效性和安全性。
这是一项针对临床实践中重度哮喘患者的前瞻性、开放标签、单臂、单中心研究（UMIN000031951）。在基线以及开始使用贝那利珠单抗后的第4周和第12周评估血液学、临床、功能和药物治疗参数。
2018年5月至2019年3月期间共纳入26例患者。在研究期间，哮喘生活质量问卷（AQLQ）评分和哮喘控制测试（ACT）评分均显著改善。第12周时，一秒用力呼气容积（FEV1）显著增加（基线：1.57升；第12周：1.75升）。与基线相比，第12周时血液嗜酸性粒细胞和嗜碱性粒细胞计数显著降低。第12周时，常规口服糖皮质激素（OCS）的剂量与基于需求使用OCS的患者数量均较基线显著减少。贝那利珠单抗对呼出一氧化氮分数（FeNO）水平和总免疫球蛋白E水平无显著影响。贝那利珠单抗治疗期间仅有1例患者出现轻度头痛。
在本研究中，贝那利珠单抗使重度哮喘患者获得了具有临床意义的益处，且无短期严重不良事件。
