Okazaki Ryota, Harada Tomoya, Funaki Yoshihiro, Morita Masato, Takata Miki, Kohno Hiroki, Ishikawa Hiroki, Inui Genki, Nishigami Miyu, Yamamoto Mitsuhiro, Listyoko Aditya Sri, Yamasaki Akira
Division of Respiratory Medicine and Rheumatology, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan.
Pulmonary and Respiratory Medicine Department, Faculty of Medicine, Brawijaya University-Dr. Saiful Anwar General Hospital, Malang 65112, Indonesia.
Yonago Acta Med. 2024 Apr 22;67(2):114-123. doi: 10.33160/yam.2024.05.003. eCollection 2024 May.
Major randomized clinical trials have shown that biological therapy can reduce the exacerbation rate and oral corticosteroid (OCS) dosage in patients with severe eosinophilic asthma. However, data on the continuation, efficacy, and safety of biological therapy in older patients with asthma are limited. Therefore, the aim of this study was to evaluate the differences in the continuation rate, efficacy, and safety of biological therapy between older (≥ 65 years) and younger (< 65 years) patients with asthma.
In this single-center retrospective observational study, we collected clinical data of patients with asthma who were administered biological drugs such as omalizumab, mepolizumab, benralizumab, and dupilumab between April 2009 and August 2022. We comparatively analyzed the continuation, efficacy, and safety of biological therapy between older (age ≥ 65 years) and younger patient (age < 65 years) groups. The reasons for discontinuation or switching of biological drugs were also evaluated.
Sixty-two (31 older and 31 younger) patients were treated with 91 biologics during the observational period. The mean age of older patients was 74.3 ± 5.1 years and that of younger patients was 48.0 ± 14.0 years. The continuation rate of biological therapy was not significantly different between the groups. Social background was the most common reason for discontinuation of biological therapy in both groups, and insufficient effect was the most common reason for switching to biological drugs. Asthma exacerbations decreased in both groups within the first 12 months of biologic therapy. The dosage of OCS tended to decrease in the older group and significantly decrease in the younger group.
Biologic therapy for older patients with asthma can be continued, with efficacy and safety similar to those in younger patients with asthma.
大型随机临床试验表明，生物疗法可降低重度嗜酸性粒细胞性哮喘患者的急性加重率并减少口服糖皮质激素（OCS）用量。然而，关于老年哮喘患者生物疗法的持续使用情况、疗效和安全性的数据有限。因此，本研究旨在评估老年（≥65岁）和年轻（<65岁）哮喘患者在生物疗法的持续使用率、疗效和安全性方面的差异。
在这项单中心回顾性观察研究中，我们收集了2009年4月至2022年8月期间接受奥马珠单抗、美泊利单抗、贝那利珠单抗和度普利尤单抗等生物药物治疗的哮喘患者的临床数据。我们对老年（年龄≥65岁）和年轻患者（年龄<65岁）组在生物疗法的持续使用情况、疗效和安全性方面进行了比较分析。还评估了生物药物停药或换药的原因。
在观察期内，62例患者（31例老年患者和31例年轻患者）接受了91次生物制剂治疗。老年患者的平均年龄为74.3±5.1岁，年轻患者的平均年龄为48.0±14.0岁。两组生物疗法的持续使用率无显著差异。社会背景是两组停用生物疗法最常见的原因，疗效不佳是换药最常见的原因。在生物疗法治疗的前12个月内，两组的哮喘急性加重均有所减少。老年组的OCS用量趋于减少，而年轻组则显著减少。
老年哮喘患者的生物疗法可以持续进行，其疗效和安全性与年轻哮喘患者相似。
