贝那利珠单抗治疗老年重度嗜酸性粒细胞性哮喘的疗效与安全性。
Efficacy and safety of benralizumab in elderly patients with severe eosinophilic asthma.
作者信息
Somekawa Kohei, Watanabe Keisuke, Seki Kenichi, Muraoka Suguru, Izawa Ami, Kaneko Ayami, Otsu Yukiko, Hirata Momo, Kubo Sousuke, Tanaka Katsushi, Nagasawa Ryo, Matsumoto Hiromi, Murohashi Kota, Fuji Hiroaki, Aoki Ayako, Horita Nobuyuki, Hara Yu, Kobayashi Nobuaki, Kudo Makoto, Kaneko Takeshi
机构信息
Department of Pulmonology, Yokohama City University Graduate School of Medicine, Yokohama, Kanazawa-ku, Japan.
Respiratory Disease Center, Yokohama City University Medical Center, Yokohama, Minami-ku, Japan.
出版信息
Eur Clin Respir J. 2024 Jul 26;11(1):2384173. doi: 10.1080/20018525.2024.2384173. eCollection 2024.
BACKGROUND
Biologics are the important drugs for severe asthma, but clinical trials included few elderly patients. Data on the safety and efficacy of benralizumab in elderly asthma patients are limited.
METHODS
This clinical study was a multicentre, retrospective, observational study at two hospitals. Patients aged ≥18 years diagnosed with severe asthma treated with benralizumab were included. Elderly patients were defined as those aged 70 years or older. Efficacy and safety were then analyzed in elderly and non-elderly patients. The primary endpoints were the annual number of asthma exacerbations for efficacy and the discontinuation rate due to adverse events for safety.
RESULTS
Between August 2016 and October 2022, 61 patients were enrolled; 10 patients were excluded, and 51 (22 elderly, 29 non-elderly) patients were analyzed. In elderly patients, the annual number of asthma exacerbations before treatment with benralizumab (pre-benralizumab) was 3.78, and the number during treatment with benralizumab was 1.26, a decrease of 2.52 (95% confidence interval [CI], 1.3 to 3.74, < 0.001). In non-elderly patients, the annual number of asthma exacerbation in the pre-benralizumab period was 3.24, and during treatment with benralizumab it was 0.68, a decrease of 2.56 (95% CI, 1.3 to 3.82, < 0.001). There was no significant difference in discontinuation due to treatment-related adverse events (elderly vs non-elderly, 2 (9%) vs 0 (0%), = 0.18).
CONCLUSION
Benralizumab reduced the annual number of asthma exacerbations and was well tolerated in elderly patients.
背景
生物制剂是治疗重度哮喘的重要药物，但临床试验纳入的老年患者较少。关于贝那利珠单抗在老年哮喘患者中的安全性和有效性数据有限。
方法
本临床研究是在两家医院进行的多中心、回顾性观察性研究。纳入年龄≥18岁、诊断为重度哮喘并接受贝那利珠单抗治疗的患者。老年患者定义为年龄70岁及以上的患者。然后对老年患者和非老年患者的疗效和安全性进行分析。主要终点指标为疗效方面的年度哮喘发作次数以及安全性方面的因不良事件导致的停药率。
结果
2016年8月至2022年10月期间，共纳入61例患者；排除10例患者，对51例患者（22例老年患者，29例非老年患者）进行分析。在老年患者中，使用贝那利珠单抗治疗前（贝那利珠单抗治疗前）的年度哮喘发作次数为3.78次，使用贝那利珠单抗治疗期间为1.26次，减少了2.52次（95%置信区间[CI]，1.3至3.74，<0.001）。在非老年患者中，贝那利珠单抗治疗前的年度哮喘发作次数为3.24次，治疗期间为0.68次，减少了2.56次（95%CI，1.3至3.82，<0.001）。因治疗相关不良事件导致的停药情况无显著差异（老年患者与非老年患者，2例（9%）对0例（0%），P = 0.18）。
结论
贝那利珠单抗减少了年度哮喘发作次数，老年患者对其耐受性良好。
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