Department of Respiratory Medicine, Tokyo Women's Medical University School of Medicine, Tokyo, Japan; Allergy Medical Center, Tokyo Women's Medical University Hospital, Tokyo, Japan.
Department of Otolaryngology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan; Allergy Medical Center, Tokyo Women's Medical University Hospital, Tokyo, Japan.
Pulm Pharmacol Ther. 2021 Jun;68:102032. doi: 10.1016/j.pupt.2021.102032. Epub 2021 Apr 19.
Omalizumab, an anti-IgE antibody, has been widely used in many countries, including Japan. However, some patients do not respond to omalizumab, and the cause of treatment failure has not been fully elucidated.
This study aimed to evaluate the characteristics of adult asthma patients who failed to achieve disease control with omalizumab in a real-world setting.
We retrospectively reviewed the medical records of patients in Tokyo Women's Medical University Hospital between March 2009 and May 2016. The patient characteristics and factors for treatment failure with omalizumab were evaluated, as were treatment alternatives after discontinuation of omalizumab.
In total, 59 patients were included in this study. The omalizumab-ineffective group had a significantly higher number of patients with eosinophilic sinusitis (P = 0.001) and eosinophilic otitis media (P = 0.023) than the omalizumab-effective group. A multivariate analysis revealed that both eosinophilic chronic rhinosinusitis (odds ratio: 23.4; P = 0.011) and eosinophilic otitis media (odds ratio: 6.71; P = 0.039) were associated with treatment failure with omalizumab. Most patients with eosinophilic comorbidities of the ear, nose, and throat (ENT) in the omalizumab-ineffective group received mepolizumab or benralizumab as alternative therapy, following which disease control was achieved.
Eosinophilic comorbidities of the ENT may affect treatment failure with omalizumab in patients with severe asthma. Anti-interleukin-5 antibody or anti-interleukin-5Rα antibody rather than anti-IgE antibody should be considered as an additional therapy for patients with severe asthma who have eosinophilic comorbidities of the ENT.
奥马珠单抗是一种抗 IgE 抗体,已在许多国家(包括日本)广泛使用。然而,一些患者对奥马珠单抗治疗无反应,且治疗失败的原因尚未完全阐明。
本研究旨在评估在真实环境中,接受奥马珠单抗治疗未能控制疾病的成年哮喘患者的特征。
我们回顾性分析了 2009 年 3 月至 2016 年 5 月期间在东京女子医科大学医院就诊的患者的病历。评估了奥马珠单抗治疗失败的患者特征和相关因素,以及奥马珠单抗停药后的治疗选择。
共纳入 59 例患者。奥马珠单抗无效组的嗜酸细胞性鼻-鼻窦炎(P=0.001)和嗜酸细胞性中耳炎(P=0.023)患者明显多于奥马珠单抗有效组。多变量分析显示,嗜酸细胞性慢性鼻-鼻窦炎(比值比:23.4;P=0.011)和嗜酸细胞性中耳炎(比值比:6.71;P=0.039)均与奥马珠单抗治疗失败相关。奥马珠单抗无效组中大多数伴发耳、鼻、喉(ENT)嗜酸粒细胞疾病的患者接受了美泊利单抗或贝那利珠单抗作为替代治疗,之后疾病得到了控制。
ENT 伴发的嗜酸粒细胞疾病可能会影响严重哮喘患者奥马珠单抗的治疗效果。对于伴发 ENT 嗜酸粒细胞疾病的严重哮喘患者,应考虑使用抗白细胞介素-5 抗体或抗白细胞介素-5Rα抗体作为辅助治疗,而非抗 IgE 抗体。