Goodall Emma, Rothnie Kieran J, Numbere Beade, Zhang Shiyuan, Compton Chris, Wood Robert, Tritton Theo, Wild Rosie, Small Mark, Vestbo Jørgen, Woodcock Ashley
Epidemiology, Organisation of the Chief Medical Officer, GSK R&D, London, UK.
Global Epidemiology, Organisation of the Chief Medical Officer, GSK R&D, London, UK.
Respir Res. 2025 Mar 29;26(1):121. doi: 10.1186/s12931-025-03199-5.
There is a need for real-world data describing the frequency and impact of moderate asthma exacerbations in patients receiving inhaled corticosteroids/long-acting β-agonists (ICS/LABA). The Salford Lung Study (SLS) and associated extension study (Ext-SLS) evaluated ICS/LABA versus existing maintenance therapy in adults with asthma. This analysis assessed the impact of moderate exacerbations in patients from the Ext-SLS.
This retrospective cohort study analysed linked primary and secondary care and patient questionnaire data from patients enrolled in the Ext-SLS (indexed April 2018-May 2019). Primary outcome was number of self-reported moderate asthma exacerbations 12 months pre-index, overall, by maintenance treatment class and asthma control status at index, using the Asthma Control Test (ACT; poor [< 16], somewhat controlled [16-18], and controlled [> 19]) and 6-item Asthma Control Questionnaire (ACQ-6; uncontrolled [≥ 1.50], partially controlled [> 0.75-<1.50], and controlled [≤ 0.75]). Secondary outcomes included index ACT and ACQ-6 score, healthcare resource utilisation (HCRU) and direct costs 12 months pre- and post-index, stratified by self-reported moderate exacerbation frequency pre-index.
Of 485 patients with ≥ 12 months' pre-index data, 86.6% (n = 420) self-reported moderate exacerbations, with similar frequency irrespective of maintenance treatment class (66.7-100.0%; ICS/LABA: 85.4%). Numerically greater proportions of patients self-reported a moderate exacerbation in the 12 months pre-index in ACT poor-control (n = 110/115 [95.7%]) and ACQ-6-uncontrolled (n = 200/210 [95.3%]) versus ACT- and ACQ-6-controlled (n = 205/260 [78.8%], n = 105/145 [72.4%]) groups. Symptom control worsened with increasing exacerbation frequency: mean (SD) ACT scores were 21.8 (3.3) and 15.7 (4.4) for patients with 0 or ≥ 7 events, respectively; mean (SD) ACQ-6 scores followed the same trend. Direct costs and HCRU increased with pre-index exacerbation frequency; mean (SD) all-cause and asthma-related total costs were £1509 (£2384) and £717 (£1459) for patients with no moderate exacerbations 12 months pre-index and £2002 (£2058) and £1086 (£1538) for patients with ≥ 7 exacerbations; similar trends occurred over 12 months post-index.
Patients with asthma experience frequent moderate exacerbations, which are associated with poor asthma control, increased HCRU and costs, emphasising the poor quality of life patients experience. Tackling poor adherence, risk behaviour, and comorbidities as well as holistic management and medication review are needed.
Registered on clinicaltrials.gov: NCT03152669, 12 May 2017.
需要有真实世界的数据来描述接受吸入性糖皮质激素/长效β受体激动剂（ICS/LABA）治疗的患者中中度哮喘急性加重的频率和影响。索尔福德肺部研究（SLS）及相关扩展研究（Ext-SLS）评估了ICS/LABA与成人哮喘现有维持治疗方案的疗效。本分析评估了Ext-SLS患者中中度急性加重的影响。
这项回顾性队列研究分析了来自Ext-SLS（索引时间为2018年4月至2019年5月）患者的初级和二级医疗保健及患者问卷关联数据。主要结局指标为索引前12个月自我报告的中度哮喘急性加重次数，总体上按维持治疗类别以及索引时的哮喘控制状态进行分析，使用哮喘控制测试（ACT；差[<16]、部分控制[16 - 18]和控制良好[>19]）和6项哮喘控制问卷（ACQ - 6；未控制[≥1.50]、部分控制[>0.75 - <1.50]和控制良好[≤0.75]）。次要结局指标包括索引时的ACT和ACQ - 6评分、医疗资源利用（HCRU）以及索引前和索引后12个月的直接成本，按索引前自我报告的中度急性加重频率进行分层。
在485例有≥12个月索引前数据的患者中，86.6%（n = 420）自我报告有中度急性加重，无论维持治疗类别如何，频率相似（66.7 - 100.0%；ICS/LABA：85.4%）。在ACT控制差（n = 110/115 [95.7%]）和ACQ - 6未控制（n = 200/210 [95.3%]）组中，自我报告在索引前12个月有中度急性加重的患者比例在数值上高于ACT和ACQ - 6控制良好（n = 205/260 [78.8%]，n = 105/145 [72.4%]）组。随着急性加重频率增加，症状控制恶化：0次或≥7次急性加重事件的患者，平均（标准差）ACT评分分别为21.8（3.3）和15.7（4.4）；平均（标准差）ACQ - 6评分呈现相同趋势。直接成本和HCRU随着索引前急性加重频率增加而增加；索引前12个月无中度急性加重的患者，平均（标准差）全因和哮喘相关总成本分别为1509英镑（2384英镑）和717英镑（1459英镑），而≥7次急性加重的患者分别为2002英镑（2058英镑）和1086英镑（1538英镑）；索引后12个月出现类似趋势。
哮喘患者经常经历中度急性加重，这与哮喘控制不佳、HCRU增加和成本上升相关，凸显了患者生活质量较差。需要解决依从性差、风险行为和合并症问题，以及进行整体管理和药物审查。
在clinicaltrials.gov注册：NCT03152669，2017年5月12日。
