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生物制剂(美泊利珠单抗和奥马珠单抗)可诱导重度哮喘患者缓解。

Biologics (mepolizumab and omalizumab) induced remission in severe asthma patients.

机构信息

Centre of Excellence in Treatable Traits, College of Health, Medicine and Wellbeing, University of Newcastle, Hunter Medical Research Institute Asthma and Breathing Programme, Newcastle, New South Wales, Australia.

Department of Respiratory and Sleep Medicine, John Hunter Hospital, Newcastle, New South Wales, Australia.

出版信息

Allergy. 2024 Feb;79(2):384-392. doi: 10.1111/all.15867. Epub 2023 Aug 25.


DOI:10.1111/all.15867
PMID:37632144
Abstract

BACKGROUND: Asthma remission has emerged as a potential treatment goal. This study evaluated the effectiveness of two biologics (mepolizumab/omalizumab) in achieving asthma remission. METHODS: This observational study included 453 severe asthma patients (41% male; mean age ± SD 55.7 ± 14.7 years) from two real-world drug registries: the Australian Mepolizumab Registry and the Australian Xolair Registry. The composite outcome clinical remission was defined as zero exacerbations and zero oral corticosteroids during the previous 6 months assessed at 12 months and 5-item Asthma Control Questionnaire (ACQ-5) ≤1 at 12 months. We also assessed clinical remission plus optimization (post-bronchodilator FEV1 ≥80%) or stabilization (post-bronchodilator FEV1 not greater than 5% decline from baseline) of lung function at 12 months. Sensitivity analyses explored various cut-offs of ACQ-5/FEV1 scores. The predictors of clinical remission were identified. RESULTS: 29.3% (73/249) of AMR and 22.8% (37/162) of AXR cohort met the criteria for clinical remission. When lung function criteria were added, the remission rates were reduced to 25.2% and 19.1%, respectively. Sensitivity analyses identified that the remission rate ranged between 18.1% and 34.9% in the AMR cohort and 10.6% and 27.2% in the AXR cohort. Better lung function, lower body mass index, mild disease and absence of comorbidities such as obesity, depression and osteoporosis predicted the odds of achieving clinical remission. CONCLUSION: Biologic treatment with mepolizumab or omalizumab for severe asthma-induced asthma remission in a subgroup of patients. Remission on treatment may be an achievable treatment target and future studies should consider remission as an outcome measure.

摘要

背景:哮喘缓解已成为一种潜在的治疗目标。本研究评估了两种生物制剂(美泊利珠单抗/奥马珠单抗)在实现哮喘缓解方面的有效性。

方法:本观察性研究纳入了来自澳大利亚美泊利珠单抗登记处和澳大利亚奥马珠单抗登记处的两个真实世界药物登记处的 453 名重度哮喘患者(41%为男性;平均年龄±标准差 55.7±14.7 岁)。复合结局临床缓解定义为在过去 6 个月内无恶化且无口服皮质激素,在 12 个月时评估,并在 12 个月时 5 项哮喘控制问卷(ACQ-5)≤1。我们还评估了 12 个月时肺功能的临床缓解加优化(支气管扩张剂后 FEV1≥80%)或稳定(支气管扩张剂后 FEV1与基线相比不超过 5%下降)。敏感性分析探索了各种 ACQ-5/FEV1 评分的截断值。确定了临床缓解的预测因素。

结果:在 AMR 组中,有 29.3%(73/249)的患者和 AXR 组中有 22.8%(37/162)的患者符合临床缓解的标准。当加入肺功能标准时,缓解率分别降至 25.2%和 19.1%。敏感性分析发现,在 AMR 组中,缓解率在 18.1%至 34.9%之间,在 AXR 组中,缓解率在 10.6%至 27.2%之间。更好的肺功能、更低的体重指数、轻度疾病以及没有肥胖、抑郁和骨质疏松等合并症预测了达到临床缓解的可能性。

结论:生物制剂治疗重度哮喘可使部分患者哮喘缓解。缓解可能是一个可实现的治疗目标,未来的研究应将缓解作为一种结局指标。

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