Dupilumab治疗哮喘的有效性和经济影响：一项基于人群的队列研究
2023/03/21
摘要
理论基础：严重的哮喘病人承受着相关的社会经济和临床影响。关于Dupilumab的随机对照试验显示出疗效和良好的安全性，但需要进行上市后研究。
研究目的：评估Dupilumab对（i）抗哮喘药物的使用，包括口服皮质类固醇（OCS）的影响；（ii）哮喘恶化相关的入院率；以及（iii）哮喘患者的医疗费用。
实验方法：数据取自伦巴第地区（意大利）的医疗卫生利用数据库。我们比较了Dupilumab启动后6个月（"干预后时期"）和（i）Dupilumab启动前6个月（"淘汰期"）以及（ii）前一年的相应6个月（"干预前时期"）之间的医疗资源使用情况。
结果：在176名患者的队列中，比较 "干预前 "和 "干预后"，Dupilumab显著减少了抗哮喘药物的使用（包括OCS和短效β2-激动剂、吸入性皮质激素（ICS）/长效β2-激动剂和ICS单独使用）。当考虑到入院情况时，我们观察到在Dupilumab之前的两个时期和干预后的时期之间没有统计学意义上的或微不足道的减少。6个月的停药率为8%。在 "干预前 "和 "干预后 "期间，总体医疗费用增加了10倍，这主要是由生物药物的费用导致。相反，与入院有关的支出没有变化。
结论：我们的真实世界调查表明，与上年同期相比，Dupilumab减少了抗哮喘药物的使用，包括OCS。然而，长期医疗保健的可持续性仍然是一个开放的问题。
Effectiveness and economic impact of Dupilumab in asthma: a population-based cohort study
Faverio, P., Ronco, R., Monzio Compagnoni, M., Franchi, M., Franco, G., Bonaiti, G., Bonifazi, M., Mei, F., Luppi, F., Pesci, A., & Corrao, G. (2023).
Abstract
RATIONALE:Severe asthma is burdened by relevant socio-economic and clinical impact. Randomized controlled trials on Dupilumab showed efficacy and a good safety profile, but post-market studies are needed.
OBJECTIVES:To evaluate the impact of Dupilumab on (i) the use of anti-asthmatic drugs, including oral corticosteroids (OCS), (ii) the rates of asthma exacerbation-related hospital admissions, and (iii) the healthcare costs in patients with asthma.
METHODS:Data were retrieved from Healthcare Utilization database of Lombardy region (Italy). We compared healthcare resources use between the 6 months after Dupilumab initiation ("post-intervention period") and (i) the 6 months before Dupilumab initiation ("wash-out period") and (ii) the corresponding 6 months of the prior year ("pre-intervention period").
MAIN RESULTS:In a cohort of 176 patients, Dupilumab significantly reduced anti-asthmatic drugs use (including OCS and short-acting β2-agonists, inhaled corticosteroids (ICS)/long-acting β2-agonists and ICS alone) when comparing the "pre-intervention" to the "post-intervention" period. When considering hospital admissions, we observed a not statistically or marginally significant reduction between both periods before Dupilumab and the post-intervention period. Six-months discontinuation rate was 8%. Overall healthcare costs had a tenfold increase between the "pre-intervention" and "post-intervention" period, which was mainly led by the biologic drug cost. Conversely, expenditures connected to hospital admissions did not change.
CONCLUSION:Our real-world investigation suggests that Dupilumab reduced anti-asthmatic drugs use, including OCS, in comparison to a corresponding period in the prior year. However, long-term healthcare sustainability remains an open issue.
理论基础：严重的哮喘病人承受着相关的社会经济和临床影响。关于Dupilumab的随机对照试验显示出疗效和良好的安全性，但需要进行上市后研究。
研究目的：评估Dupilumab对（i）抗哮喘药物的使用，包括口服皮质类固醇（OCS）的影响；（ii）哮喘恶化相关的入院率；以及（iii）哮喘患者的医疗费用。
实验方法：数据取自伦巴第地区（意大利）的医疗卫生利用数据库。我们比较了Dupilumab启动后6个月（"干预后时期"）和（i）Dupilumab启动前6个月（"淘汰期"）以及（ii）前一年的相应6个月（"干预前时期"）之间的医疗资源使用情况。
结果：在176名患者的队列中，比较 "干预前 "和 "干预后"，Dupilumab显著减少了抗哮喘药物的使用（包括OCS和短效β2-激动剂、吸入性皮质激素（ICS）/长效β2-激动剂和ICS单独使用）。当考虑到入院情况时，我们观察到在Dupilumab之前的两个时期和干预后的时期之间没有统计学意义上的或微不足道的减少。6个月的停药率为8%。在 "干预前 "和 "干预后 "期间，总体医疗费用增加了10倍，这主要是由生物药物的费用导致。相反，与入院有关的支出没有变化。
结论：我们的真实世界调查表明，与上年同期相比，Dupilumab减少了抗哮喘药物的使用，包括OCS。然而，长期医疗保健的可持续性仍然是一个开放的问题。
(中日友好医院呼吸与危重症医学科 沈焜路 摘译 林江涛 审校)
(Respir Res. 2023 Mar 7. DOI: 10.1186/s12931-023-02372-y)
(Respir Res. 2023 Mar 7. DOI: 10.1186/s12931-023-02372-y)
Effectiveness and economic impact of Dupilumab in asthma: a population-based cohort study
Faverio, P., Ronco, R., Monzio Compagnoni, M., Franchi, M., Franco, G., Bonaiti, G., Bonifazi, M., Mei, F., Luppi, F., Pesci, A., & Corrao, G. (2023).
Abstract
RATIONALE:Severe asthma is burdened by relevant socio-economic and clinical impact. Randomized controlled trials on Dupilumab showed efficacy and a good safety profile, but post-market studies are needed.
OBJECTIVES:To evaluate the impact of Dupilumab on (i) the use of anti-asthmatic drugs, including oral corticosteroids (OCS), (ii) the rates of asthma exacerbation-related hospital admissions, and (iii) the healthcare costs in patients with asthma.
METHODS:Data were retrieved from Healthcare Utilization database of Lombardy region (Italy). We compared healthcare resources use between the 6 months after Dupilumab initiation ("post-intervention period") and (i) the 6 months before Dupilumab initiation ("wash-out period") and (ii) the corresponding 6 months of the prior year ("pre-intervention period").
MAIN RESULTS:In a cohort of 176 patients, Dupilumab significantly reduced anti-asthmatic drugs use (including OCS and short-acting β2-agonists, inhaled corticosteroids (ICS)/long-acting β2-agonists and ICS alone) when comparing the "pre-intervention" to the "post-intervention" period. When considering hospital admissions, we observed a not statistically or marginally significant reduction between both periods before Dupilumab and the post-intervention period. Six-months discontinuation rate was 8%. Overall healthcare costs had a tenfold increase between the "pre-intervention" and "post-intervention" period, which was mainly led by the biologic drug cost. Conversely, expenditures connected to hospital admissions did not change.
CONCLUSION:Our real-world investigation suggests that Dupilumab reduced anti-asthmatic drugs use, including OCS, in comparison to a corresponding period in the prior year. However, long-term healthcare sustainability remains an open issue.
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度普利尤单抗对口服皮质类固醇依赖性重度哮喘的呼吸困难、睡眠和活动的长期影响
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