使用度普利尤单抗治疗24个月的重度哮喘患者的临床缓解和完全缓解
Clinical and complete remission in patients with severe asthma with 24-month dupilumab treatment.
作者信息
Tajiri Tomoko, Suzuki Motohiko, Nishiyama Hirono, Suzuki Tatsuro, Amakusa Yuki, Ito Keima, Mori Yuta, Fukumitsu Kensuke, Fukuda Satoshi, Kanemitsu Yoshihiro, Uemura Takehiro, Ohkubo Hirotsugu, Takemura Masaya, Ito Yutaka, Oguri Tetsuya, Niimi Akio
机构信息
Department of Respiratory Medicine, Allergy and Clinical Immunology, Graduate School of Medical Sciences, Nagoya City University, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Aichi, Japan.
Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medical Sciences, Nagoya City University, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Aichi, Japan.
出版信息
Respir Investig. 2025 Sep;63(5):711-717. doi: 10.1016/j.resinv.2025.06.002. Epub 2025 Jun 6.
BACKGROUND
A few studies have reported asthma clinical remission with 24-month dupilumab therapy; however, complete remission remains unknown. In this post hoc analysis of our previous study, the achievement rates of clinical and complete remissions, and the factors associated with clinical remission with 24-month dupilumab therapy were assessed in adult patients with severe asthma.
METHODS
Twenty-eight patients who had participated in our previous study were included. The primary outcome was the achievement rates of three-component clinical remission, four-component clinical remission, and complete remission at 24 months. The secondary outcome was the factors associated with achievement of four-component clinical remission at 24 months. Three-component or four-component clinical remission was defined as: 1) no significant asthma symptoms; 2) oral corticosteroid-free; 3) exacerbation-free; with or without 4) normalized pulmonary function. Complete remission was defined as four-component clinical remission plus 5) the resolution of asthma-related inflammation and 6) negative airway hyperresponsiveness.
RESULTS
At 24 months, 19 (68 %), 16 (57 %), and 2 patients (7 %) achieved three-component, four-component clinical remission, and complete remission, respectively. At 24 months, patients with a higher incidence of comorbid chronic rhinosinusitis with nasal polyps, lower incidence of comorbid depression/anxiety, higher type 2 biomarkers, lower inhaled corticosteroid dose, better asthma control at baseline, and fewer exacerbations, unscheduled physicians' visit or hospitalization in the previous year more frequently achieved four-component clinical remission than those without (all P < 0.05).
CONCLUSIONS
The achievement rates of clinical or complete remission were maintained for up to 24 months in patients with severe asthma receiving dupilumab therapy.
TRIAL REGISTRATION
This study was registered in the UMIN Clinical Trial Registry (UMIN000038669).
背景
少数研究报告了使用度普利尤单抗治疗24个月后哮喘临床缓解的情况；然而，完全缓解情况仍不明确。在对我们之前研究的这项事后分析中，评估了重度哮喘成年患者中临床缓解和完全缓解的达成率，以及与24个月度普利尤单抗治疗临床缓解相关的因素。
方法
纳入了28名参与过我们之前研究的患者。主要结局是24个月时三要素临床缓解、四要素临床缓解和完全缓解的达成率。次要结局是与24个月时四要素临床缓解达成相关的因素。三要素或四要素临床缓解定义为：1）无明显哮喘症状；2）无需口服糖皮质激素；3）无急性加重；有或无4）肺功能正常。完全缓解定义为四要素临床缓解加上5）哮喘相关炎症消退和6）气道高反应性阴性。
结果
24个月时，分别有19名（68%）、16名（57%）和2名患者（7%）实现了三要素、四要素临床缓解和完全缓解。24个月时，合并慢性鼻-鼻窦炎伴鼻息肉发生率较高、合并抑郁/焦虑发生率较低、2型生物标志物水平较高、吸入糖皮质激素剂量较低、基线哮喘控制较好以及前一年急性加重、非计划就诊或住院次数较少的患者，比未达到这些情况的患者更频繁地实现四要素临床缓解（所有P<0.05）。
结论
接受度普利尤单抗治疗的重度哮喘患者临床或完全缓解的达成率可维持长达24个月。
试验注册
本研究在日本大学医学信息网络临床试验注册中心注册（UMIN00Q038669）。
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