度普利尤单抗治疗慢阻肺病的临床疗效和安全性：一项为期7年的人群队列研究
2025/06/16
摘要
背景：前期一项随访52周的随机对照试验已经证实了度普利尤单抗在接受三联疗法慢性阻塞性肺疾病（COPD）患者中的疗效。
目的：本研究为基于人群的队列研究，旨在探讨度普利尤单抗在COPD患者中的长期安全性和有效性。
方法：该研究纳入2017年4月至2024年8月期间就诊且开始接受度普利尤单抗联合长效 β2-激动剂（LABA）吸入治疗的美国COPD患者（排除哮喘和肺癌患者）。评估接受度普利尤单抗联合LABA治疗后COPD患者的结局情况。
结果：共纳入1521 例接受度普利尤单抗联合LABA治疗和1521 例仅接受LABA治疗的COPD患者。结果显示，联合度普利尤单抗治疗与较低的全因死亡率 （HR = 0.53,95% CI = 0.43-0.65）、较少的急诊就诊次数（HR = 0.78,95% CI = 0.69-0.89） 和较低的急性加重率（HR = 0.59,95% CI = 0.53-0.65）相关。度普利尤单抗还与用于控制症状的短效 β2 受体激动剂（HR = 0.48,95% CI = 0.43-0.52）和短效胆碱能受体拮抗剂 （HR = 0.43,95% CI = 0.37-0.49）的需求减少有关。此外，度普利尤单抗降低了后续肺炎（HR = 0.65,95% CI = 0.50-0.86）和COPD相关合并症的发生率，包括新发心力衰竭（HR = 0.69,95% CI = 0.53-0.90）和新发焦虑（HR = 0.70,95% CI =0.53-0.93）。
结论：COPD患者接受度普利尤单抗治疗可降低死亡率、急诊就诊以及急性加重频率，并且降低呼吸道症状和呼吸道感染的发生风险。未来需要开展更多的研究来验证其疗效。
关键词：COPD、抗 IL-4 受体、抗 IL-13 受体、急性加重
文献来源：（Sun CY, Tesfaigzi Y, Lee GY, Chen YH, Weiss ST, Ma KS. Clinical effectiveness and safety of dupilumab in patients with chronic obstructive pulmonary disease: A 7-year population-based cohort study. J Allergy Clin Immunol. 2025 Jan ; 155(1):219-222.e1.Erratum in: J Allergy Clin Immunol. 2025 Apr;155(4):1400. doi: 10.1016/j.jaci. 2025.02.001.）
Abstract
Objective: This population-based cohort study aimed to explore the long-term safety and effectiveness of dupilumab in patients with COPD.
Methods: The study included US patients with COPD who were seen between April 2017 and August 2024. Patients initiating dupilumab and therapies that incorporated long-acting β2-agonist (LABA) inhalers were included. Patients with asthma or lung cancer were excluded. The risk of outcomes occurring after initiation of dupilumab versus LABA-containing therapies was measured.
Results:A total of 1521 dupilumab initiators and 1521 propensity score–matched patients who were receiving LABA-based therapies were included. Receiving dupilumab was associated with lower all-cause mortality (hazard ratio [HR] = 0.53, 95% CI = 0.43-0.65), fewer emergency department visits (HR = 0.78, 95% CI = 0.69-0.89), and lower acute exacerbation rates (HR = 0.59, 95% CI = 0.53-0.65). Dupilumab was also associated with reductions in the requirement for short-acting β2-agonists (HR = 0.48, 95% CI = 0.43-0.52) and short-acting muscarinic antagonists (HR = 0.43, 95% CI = 0.37-0.49) for symptom control. Additionally, dupilumab decreased rates of subsequent pneumonia (HR = 0.65, 95% CI = 0.50-0.86), and COPD-relevant comorbidities, including new-onset heart failure (HR = 0.69, 95% CI = 0.53-0.90) and new-onset anxiety (HR = 0.70, 95% CI =0.53-0.93).
Conclusions: In patients with COPD, dupilumab was associated with a lower mortality rate, fewer emergency department visits, and a reduced risk of acute exacerbations, respiratory symptoms, and respiratory infections. More studies are needed to validate the efficacy of dupilumab among patients with COPD of various severities.
Keywords: COPD,anti–IL-4 receptor,anti–IL-13 receptor,acute exacerbations
背景：前期一项随访52周的随机对照试验已经证实了度普利尤单抗在接受三联疗法慢性阻塞性肺疾病（COPD）患者中的疗效。
目的：本研究为基于人群的队列研究，旨在探讨度普利尤单抗在COPD患者中的长期安全性和有效性。
方法：该研究纳入2017年4月至2024年8月期间就诊且开始接受度普利尤单抗联合长效 β2-激动剂（LABA）吸入治疗的美国COPD患者（排除哮喘和肺癌患者）。评估接受度普利尤单抗联合LABA治疗后COPD患者的结局情况。
结果：共纳入1521 例接受度普利尤单抗联合LABA治疗和1521 例仅接受LABA治疗的COPD患者。结果显示，联合度普利尤单抗治疗与较低的全因死亡率 （HR = 0.53,95% CI = 0.43-0.65）、较少的急诊就诊次数（HR = 0.78,95% CI = 0.69-0.89） 和较低的急性加重率（HR = 0.59,95% CI = 0.53-0.65）相关。度普利尤单抗还与用于控制症状的短效 β2 受体激动剂（HR = 0.48,95% CI = 0.43-0.52）和短效胆碱能受体拮抗剂 （HR = 0.43,95% CI = 0.37-0.49）的需求减少有关。此外，度普利尤单抗降低了后续肺炎（HR = 0.65,95% CI = 0.50-0.86）和COPD相关合并症的发生率，包括新发心力衰竭（HR = 0.69,95% CI = 0.53-0.90）和新发焦虑（HR = 0.70,95% CI =0.53-0.93）。
结论：COPD患者接受度普利尤单抗治疗可降低死亡率、急诊就诊以及急性加重频率，并且降低呼吸道症状和呼吸道感染的发生风险。未来需要开展更多的研究来验证其疗效。
关键词：COPD、抗 IL-4 受体、抗 IL-13 受体、急性加重
文献来源：（Sun CY, Tesfaigzi Y, Lee GY, Chen YH, Weiss ST, Ma KS. Clinical effectiveness and safety of dupilumab in patients with chronic obstructive pulmonary disease: A 7-year population-based cohort study. J Allergy Clin Immunol. 2025 Jan ; 155(1):219-222.e1.Erratum in: J Allergy Clin Immunol. 2025 Apr;155(4):1400. doi: 10.1016/j.jaci. 2025.02.001.）
（南方医科大学南方医院 欧阳文珊 龚钊乾 赵文驱）
Clinical effectiveness and safety of dupilumab in patients with chronic obstructive pulmonary disease: A 7-year population-based cohort study
Abstract
Background: Previous randomized controlled trials have established the efficacy of dupilumab among patients with chronic obstructive pulmonary disease (COPD) treated with triple therapy over 52 weeks of follow-up.
Objective: This population-based cohort study aimed to explore the long-term safety and effectiveness of dupilumab in patients with COPD.Methods: The study included US patients with COPD who were seen between April 2017 and August 2024. Patients initiating dupilumab and therapies that incorporated long-acting β2-agonist (LABA) inhalers were included. Patients with asthma or lung cancer were excluded. The risk of outcomes occurring after initiation of dupilumab versus LABA-containing therapies was measured.
Results:A total of 1521 dupilumab initiators and 1521 propensity score–matched patients who were receiving LABA-based therapies were included. Receiving dupilumab was associated with lower all-cause mortality (hazard ratio [HR] = 0.53, 95% CI = 0.43-0.65), fewer emergency department visits (HR = 0.78, 95% CI = 0.69-0.89), and lower acute exacerbation rates (HR = 0.59, 95% CI = 0.53-0.65). Dupilumab was also associated with reductions in the requirement for short-acting β2-agonists (HR = 0.48, 95% CI = 0.43-0.52) and short-acting muscarinic antagonists (HR = 0.43, 95% CI = 0.37-0.49) for symptom control. Additionally, dupilumab decreased rates of subsequent pneumonia (HR = 0.65, 95% CI = 0.50-0.86), and COPD-relevant comorbidities, including new-onset heart failure (HR = 0.69, 95% CI = 0.53-0.90) and new-onset anxiety (HR = 0.70, 95% CI =0.53-0.93).
Conclusions: In patients with COPD, dupilumab was associated with a lower mortality rate, fewer emergency department visits, and a reduced risk of acute exacerbations, respiratory symptoms, and respiratory infections. More studies are needed to validate the efficacy of dupilumab among patients with COPD of various severities.
Keywords: COPD,anti–IL-4 receptor,anti–IL-13 receptor,acute exacerbations
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重度哮喘急性加重的预测通路：一项贝叶斯网络分析研究
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哮喘与新冠肺炎：基于不同内表型揭示预后差异及治疗影响
