经24个月dupilumab治疗的严重哮喘患者的临床和完全缓解

IF 2.4 Q2 RESPIRATORY SYSTEM

Respiratory investigation Pub Date : 2025-06-06 DOI:10.1016/j.resinv.2025.06.002

Tomoko Tajiri , Motohiko Suzuki , Hirono Nishiyama , Tatsuro Suzuki , Yuki Amakusa , Keima Ito , Yuta Mori , Kensuke Fukumitsu , Satoshi Fukuda , Yoshihiro Kanemitsu , Takehiro Uemura , Hirotsugu Ohkubo , Masaya Takemura , Yutaka Ito , Tetsuya Oguri , Akio Niimi

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引用次数: 0

摘要

少数研究报道了24个月dupilumab治疗后哮喘临床缓解；然而，完全缓解仍然未知。在我们之前研究的事后分析中，评估了成人严重哮喘患者接受24个月dupilumab治疗后的临床缓解率和完全缓解率，以及与临床缓解相关的因素。方法纳入我们前期研究的患者28例。主要结局是三组分临床缓解率、四组分临床缓解率和24个月完全缓解率。次要结果是与24个月时实现四组分临床缓解相关的因素。三组分或四组分临床缓解定义为：1)无明显哮喘症状；2)口服不含皮质类固醇；3) exacerbation-free;有无正常肺功能。完全缓解被定义为四部分临床缓解加上5)哮喘相关炎症的消退和6)气道负性高反应性。结果24个月时，分别有19例（68%）、16例（57%）和2例（7%）患者达到三组分、四组分临床缓解和完全缓解。在24个月时，伴有鼻息肉共病性慢性鼻窦炎发生率较高、共病性抑郁/焦虑发生率较低、2型生物标志物较高、吸入皮质类固醇剂量较低、基线时哮喘控制较好、前一年发作较少、未安排的医生就诊或住院的患者比未伴有鼻息肉共病性慢性鼻窦炎的患者更频繁地获得四组分临床缓解(P <；0.05)。结论在接受dupilumab治疗的重症哮喘患者中，临床缓解率或完全缓解率可维持长达24个月。试验注册本研究已在UMIN临床试验注册中心注册（UMIN000038669）。

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Clinical and complete remission in patients with severe asthma with 24-month dupilumab treatment

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.