屋尘螨 SCIT 可降低哮喘风险并显着改善长期鼻炎和哮喘控制-一项 RWE 研究
2024/03/26
摘要
背景：德国治疗过敏原条例 （TAO）引发了室内尘螨 （HDM） 过敏原免疫治疗 （AIT） 产品市场的持续动荡。三种 HDM 皮下 AIT （SCIT） 产品在德国获得批准，因此将在 2026 年计划完成 TAO 手续后上市。一般来说，关于HDM AIT长期有效性的临床试验数据很少。我们在一项回顾性观察性队列研究中评估了真实世界数据 （RWD），该研究基于纵向索赔数据库，包括 60% 的德国法定医疗保健处方，以显示其中一种产品在日常生活中的长期有效性。该分析的目的是根据国际AIT指南的要求，对螨虫AIT的有效性进行按产品分析。
方法：纳入受试者年龄在5岁至70岁之间，在2009年至2013年期间首次接受SCIT(指标)处方并使用天然HDM产品(SCIT组)。完全 3：1 匹配的对照组（非 AIT 组）只接受对症药物治疗;长达 6 年的随访评估期于 2017 年 2 月结束。研究终点是过敏性鼻炎（AR）和哮喘的进展、哮喘的发生率以及至少2治疗年后哮喘发作的时间。
结果：总共有892名受试者（608名成人和284名儿童/青少年）被纳入SCIT组，2676名受试者（1824名成人和852名儿童/青少年）被纳入非AIT组。在至少2年SCIT后的随访期间，SCIT组的AR药物处方数量减少62.8%（p<0.0001），哮喘药物减少了42.4%（p=0.0003）。与非AIT组相比，SCIT组的新发哮喘风险显著降低了27.0%（p=0.0212）。SCIT的哮喘预防作用发生在治疗开始后15个月。在SCIT组中，与非AIT组相比，哮喘发作时间延长（p=0.0010）。
结论：在首个使用天然HDM产品对SCIT进行基于产品的RWD分析中，5至70岁的患者在至少2年的治疗后长期受益于AIT，减少AR和哮喘的进展。治疗终止后，效果似乎持续了长达6年。治疗15个月后，观察到哮喘发作风险显著降低。
House dust mite SCIT reduces asthma risk and significantly improves long-term rhinitis and asthma control-A RWE study.
Jutel M, Klimek L, Richter H,
Abstrast
Background: The German Therapy Allergen Ordinance (TAO) triggered an ongoing upheaval in the market for house dust mite (HDM) allergen immunotherapy (AIT) products. Three HDM subcutaneous AIT (SCIT) products hold approval in Germany and therefore will be available after the scheduled completion of the TAO procedure in 2026. In general, data from clinical trials on the long-term effectiveness of HDM AIT are rare. We evaluated real-world data (RWD) in a retrospective, observational cohort study based on a longitudinal claims database including 60% of all German statutory healthcare prescriptions to show the long-term effectiveness of one of these products in daily life. Aim of this analysis was to provide a per product analysis on effectiveness of mite AIT as it is demanded by international guidelines on AIT.
Methods: Subjects between 5 and 70 years receiving their first (index) prescription of SCIT with a native HDM product (SCIT group) between 2009 and 2013 were included. The exactly 3:1 matched control group received prescriptions for only symptomatic AR medication (non-AIT group); the evaluation period for up to 6 years of follow-up ended in February 2017. Study endpoints were the progression of allergic rhinitis (AR) and asthma, asthma occurrence and time to the onset of asthma after at least 2 treatment years.
Results：In total, 892 subjects (608 adults and 284 children/adolescents) were included in the SCIT group and 2676 subjects (1824 adults and 852 children/adolescents) in the non-AIT group. During the follow-up period after at least 2 years of SCIT, the number of prescriptions in the SCIT group was reduced by 62.8% (p < .0001) for AR medication and by 42.4% for asthma medication (p = .0003). New-onset asthma risk was significantly reduced in the SCIT vs non-AIT group by 27.0% (p = .0212). The asthma-preventive effect of SCIT occurred 15 months after start of the treatment. In the SCIT group, the time to onset of asthma was prolonged compared to the non-AIT group (p = .0010).
Conclusions: In this first product based RWD analysis on SCIT with a native HDM product, patients aged 5 to 70 years benefited from AIT in the long term in terms of reduced progression of AR and asthma after at least 2 years of treatment. The effects seemed to last for up to 6 years after treatment termination. A significantly reduced risk of asthma onset was observed, starting after 15 months of treatment.
背景：德国治疗过敏原条例 （TAO）引发了室内尘螨 （HDM） 过敏原免疫治疗 （AIT） 产品市场的持续动荡。三种 HDM 皮下 AIT （SCIT） 产品在德国获得批准，因此将在 2026 年计划完成 TAO 手续后上市。一般来说，关于HDM AIT长期有效性的临床试验数据很少。我们在一项回顾性观察性队列研究中评估了真实世界数据 （RWD），该研究基于纵向索赔数据库，包括 60% 的德国法定医疗保健处方，以显示其中一种产品在日常生活中的长期有效性。该分析的目的是根据国际AIT指南的要求，对螨虫AIT的有效性进行按产品分析。
方法：纳入受试者年龄在5岁至70岁之间，在2009年至2013年期间首次接受SCIT(指标)处方并使用天然HDM产品(SCIT组)。完全 3：1 匹配的对照组（非 AIT 组）只接受对症药物治疗;长达 6 年的随访评估期于 2017 年 2 月结束。研究终点是过敏性鼻炎（AR）和哮喘的进展、哮喘的发生率以及至少2治疗年后哮喘发作的时间。
结果：总共有892名受试者（608名成人和284名儿童/青少年）被纳入SCIT组，2676名受试者（1824名成人和852名儿童/青少年）被纳入非AIT组。在至少2年SCIT后的随访期间，SCIT组的AR药物处方数量减少62.8%（p<0.0001），哮喘药物减少了42.4%（p=0.0003）。与非AIT组相比，SCIT组的新发哮喘风险显著降低了27.0%（p=0.0212）。SCIT的哮喘预防作用发生在治疗开始后15个月。在SCIT组中，与非AIT组相比，哮喘发作时间延长（p=0.0010）。
结论：在首个使用天然HDM产品对SCIT进行基于产品的RWD分析中，5至70岁的患者在至少2年的治疗后长期受益于AIT，减少AR和哮喘的进展。治疗终止后，效果似乎持续了长达6年。治疗15个月后，观察到哮喘发作风险显著降低。
(中日友好医院呼吸与危重症医学科 万静萱 摘译 林江涛 审校)
(Allergy 2024 Mar 02; doi: 10.1111/all.16052.IF：8.706)
(Allergy 2024 Mar 02; doi: 10.1111/all.16052.IF：8.706)
House dust mite SCIT reduces asthma risk and significantly improves long-term rhinitis and asthma control-A RWE study.
Jutel M, Klimek L, Richter H,
Abstrast
Background: The German Therapy Allergen Ordinance (TAO) triggered an ongoing upheaval in the market for house dust mite (HDM) allergen immunotherapy (AIT) products. Three HDM subcutaneous AIT (SCIT) products hold approval in Germany and therefore will be available after the scheduled completion of the TAO procedure in 2026. In general, data from clinical trials on the long-term effectiveness of HDM AIT are rare. We evaluated real-world data (RWD) in a retrospective, observational cohort study based on a longitudinal claims database including 60% of all German statutory healthcare prescriptions to show the long-term effectiveness of one of these products in daily life. Aim of this analysis was to provide a per product analysis on effectiveness of mite AIT as it is demanded by international guidelines on AIT.
Methods: Subjects between 5 and 70 years receiving their first (index) prescription of SCIT with a native HDM product (SCIT group) between 2009 and 2013 were included. The exactly 3:1 matched control group received prescriptions for only symptomatic AR medication (non-AIT group); the evaluation period for up to 6 years of follow-up ended in February 2017. Study endpoints were the progression of allergic rhinitis (AR) and asthma, asthma occurrence and time to the onset of asthma after at least 2 treatment years.
Results：In total, 892 subjects (608 adults and 284 children/adolescents) were included in the SCIT group and 2676 subjects (1824 adults and 852 children/adolescents) in the non-AIT group. During the follow-up period after at least 2 years of SCIT, the number of prescriptions in the SCIT group was reduced by 62.8% (p < .0001) for AR medication and by 42.4% for asthma medication (p = .0003). New-onset asthma risk was significantly reduced in the SCIT vs non-AIT group by 27.0% (p = .0212). The asthma-preventive effect of SCIT occurred 15 months after start of the treatment. In the SCIT group, the time to onset of asthma was prolonged compared to the non-AIT group (p = .0010).
Conclusions: In this first product based RWD analysis on SCIT with a native HDM product, patients aged 5 to 70 years benefited from AIT in the long term in terms of reduced progression of AR and asthma after at least 2 years of treatment. The effects seemed to last for up to 6 years after treatment termination. A significantly reduced risk of asthma onset was observed, starting after 15 months of treatment.
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吸入性皮质类固醇/长效β-受体激动剂治疗的哮喘患者病情加重的频率和经济负担：一项回顾性美国索赔研究
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支气管扩张和哮喘：来自欧洲支气管扩张登记处（EMBARC）的数据
