Department of Respiratory Medicine, Shizuoka General Hospital, Shizuoka, Japan.
Department of Clinical Pharmacology and Genetics, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.
J Asthma. 2022 Sep;59(9):1796-1804. doi: 10.1080/02770903.2021.1963769. Epub 2021 Aug 17.
Benralizumab is a promising drug for severe uncontrolled asthma. This study aimed to clarify the effectiveness of benralizumab in a real-life setting.
Subjects included 24 patients with severe type 2 asthma who received benralizumab between April 2018 and July 2019. Changes in parameters, exacerbation frequency, and oral corticosteroid (OCS) use after 4 and 24 weeks of administration were examined. The parameters included the Global Evaluation of Treatment Effectiveness (GETE) scale, Asthma Control Questionnaire (ACQ), Asthma Control Test (ACT), blood eosinophils, fractional exhaled nitric oxide (FeNO), and spirometry. The response to treatment was defined as follows: for patients with exacerbations or OCS use before treatment initiation, a reduction of ≥50% in exacerbation frequency or OCS use; and for patients without exacerbations or OCS use, an improvement of ≥0.5 in ACQ scores and ≥3 in ACT scores, or of ≥10.38% in FEV1.
Twenty-one patients completed the treatment for 24 weeks. Excellent and good GETE scales and ACQ and ACT improvement were found in 67% of the patients at 4 weeks, and the effect continued until 24 weeks. The patients' rate with exacerbations was significantly reduced compared to the previous 24 weeks before administration. In 17 patients receiving OCS, the use could be reduced or quit in 14 patients. Overall, 16 patients (76.2%) met the responder definition and could be predicted by the baseline eosinophil count and FeNO levels with the best cutoff values of 100/μL and 40 ppb, respectively.
Blood eosinophil and FeNO could predict benralizumab effectiveness.
贝那鲁肽是一种有前途的重度未控制型哮喘药物。本研究旨在明确贝那鲁肽在真实环境中的疗效。
本研究纳入了 2018 年 4 月至 2019 年 7 月期间接受贝那鲁肽治疗的 24 例重度 2 型哮喘患者。观察治疗 4 周和 24 周后患者各项参数、哮喘加重频率和口服皮质类固醇(OCS)的使用变化。参数包括总体治疗效果评估量表(GETE)、哮喘控制问卷(ACQ)、哮喘控制测试(ACT)、血嗜酸性粒细胞计数、呼出气一氧化氮(FeNO)和肺功能。治疗反应定义为:对于治疗前有加重或使用 OCS 的患者,减轻≥50%的哮喘加重频率或 OCS 使用量;对于无加重或使用 OCS 的患者,ACQ 评分提高≥0.5,ACT 评分提高≥3,或 FEV1 提高≥10.38%。
21 例患者完成了 24 周的治疗。在第 4 周时,67%的患者达到了良好的 GTE 评分和 ACQ 评分以及 ACT 评分改善,这种效果一直持续到第 24 周。与治疗前的 24 周相比,患者的哮喘加重率显著降低。在 17 例接受 OCS 的患者中,有 14 例可以减少或停用 OCS。总体而言,16 例(76.2%)患者符合应答者定义,可根据基线嗜酸性粒细胞计数和 FeNO 水平预测,最佳截断值分别为 100/μL 和 40 ppb。
血嗜酸性粒细胞计数和 FeNO 可预测贝那鲁肽的疗效。