Abstract：
BACKGROUND: Real-world data assessing characteristics of patients with asthma initiating inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist (ICS/LAMA/LABA) triple therapy in Japan are limited.
METHODS: Descriptive, observational study of patients with asthma aged ≥15 years newly initiating single- or multiple-inhaler triple therapy (SITT: fluticasone furoate/umeclidinium/vilanterol [FF/UMEC/VI], SITT: indacaterol/glycopyrronium bromide/mometasone furoate [IND/GLY/MF] or MITT) or ICS/LABA using JMDC/Medical Data Vision (MDV) health insurance databases from February 2021-February 2022 (first prescription date: index date). Patients were assigned to three non-mutually exclusive cohorts: A) new FF/UMEC/VI initiators; B) new FF/UMEC/VI, IND/GLY/MF, or MITT initiators; C) new FF/UMEC/VI, IND/GLY/MF, MITT or ICS/LABA initiators as initial maintenance therapy (IMT). Patient characteristics were assessed descriptively for 12-months pre-treatment initiation (baseline period).
RESULTS: Cohort A: among new FF/UMEC/VI initiators, 12.8% and 0.1% (JMDC) and 21.7% and 0.9% (MDV) of patients had ≥1 moderate and severe exacerbation; 52.0% (JMDC) and 79.2% (MDV) had ICS/LABA use. Cohort B: most patients initiated FF/UMEC/VI and IND/GLY/MF over MITT (JMDC: 91.3% vs 8.7%; MDV: 67.8% vs 32.2%), with fewer exacerbations and lower rescue medication use. Cohort C: a greater proportion of FF/UMEC/VI initiators as IMT experienced a moderate exacerbation at index versus ICS/LABA initiators as IMT (JMDC: 17.8% vs 10.7%; MDV: 8.0% vs 5.1%).
CONCLUSIONS: Patient characteristics were generally similar between treatment groups; SITT initiators had fewer exacerbations and lower rescue medication use than MITT initiators, represented by the greater proportion of IMT among SITT versus MITT initiators. Physicians may have prescribed triple over dual therapy as IMT in response to an exacerbation.
METHODS: Descriptive, observational study of patients with asthma aged ≥15 years newly initiating single- or multiple-inhaler triple therapy (SITT: fluticasone furoate/umeclidinium/vilanterol [FF/UMEC/VI], SITT: indacaterol/glycopyrronium bromide/mometasone furoate [IND/GLY/MF] or MITT) or ICS/LABA using JMDC/Medical Data Vision (MDV) health insurance databases from February 2021-February 2022 (first prescription date: index date). Patients were assigned to three non-mutually exclusive cohorts: A) new FF/UMEC/VI initiators; B) new FF/UMEC/VI, IND/GLY/MF, or MITT initiators; C) new FF/UMEC/VI, IND/GLY/MF, MITT or ICS/LABA initiators as initial maintenance therapy (IMT). Patient characteristics were assessed descriptively for 12-months pre-treatment initiation (baseline period).
RESULTS: Cohort A: among new FF/UMEC/VI initiators, 12.8% and 0.1% (JMDC) and 21.7% and 0.9% (MDV) of patients had ≥1 moderate and severe exacerbation; 52.0% (JMDC) and 79.2% (MDV) had ICS/LABA use. Cohort B: most patients initiated FF/UMEC/VI and IND/GLY/MF over MITT (JMDC: 91.3% vs 8.7%; MDV: 67.8% vs 32.2%), with fewer exacerbations and lower rescue medication use. Cohort C: a greater proportion of FF/UMEC/VI initiators as IMT experienced a moderate exacerbation at index versus ICS/LABA initiators as IMT (JMDC: 17.8% vs 10.7%; MDV: 8.0% vs 5.1%).
CONCLUSIONS: Patient characteristics were generally similar between treatment groups; SITT initiators had fewer exacerbations and lower rescue medication use than MITT initiators, represented by the greater proportion of IMT among SITT versus MITT initiators. Physicians may have prescribed triple over dual therapy as IMT in response to an exacerbation.
摘要：
背景：在日本，评估哮喘患者吸入皮质类固醇/长效毒蕈碱拮抗剂/长效β2激动剂（ICS/LAMA/LABA）三联疗法特征的实际数据有限。
方法：描述性，新开始单或多吸入三联疗法的年龄≥15岁的哮喘患者的观察性研究（SITT：糠酸氟替卡松/灭克地铵/维兰特罗[FF/UMEC/VI]，SITT：茚达特罗/格隆溴铵/糠酸莫米松[IND/GLY/MF或MITT）或ICS/LABA使用JMDC/MedicalDataVision（MDV）健康保险数据库，从2021年2月至2022年2月（首次处方日期：索引日期）。患者被分配到三个非相互排斥的队列：A）新的FF/UMEC/VI发起者；B）新的FF/UMEC/VI，IND/GLY/MF,或MITT引发剂；C）新的FF/UMEC/VI，IND/GLY/MF,MITT或ICS/LABA引发剂作为初始维持疗法(IMT)。在治疗开始前12个月（基线期）对患者特征进行描述性评估。
结果：队列A：在新的FF/UMEC/VI引发剂中，12.8％和0.1％（JMDC）以及21.7％和0.9％（MDV）的患者出现≥1次中度和重度加重；52.0％（JMDC）和79.2％（MDV）使用ICS/LABA。队列B：大多数患者开始FF/UMEC/VI和IND/GLY/MF超过MITT（JMDC：91.3％vs8.7％；MDV：67.8％vs32.2％），减少恶化和较低的救护药物使用。队列C：作为IMT的FF/UMEC/VI引发剂的比例更高，与作为IMT的ICS/LABA引发剂相比，指数中度加重（JMDC：17.8％对10.7％；MDV：8.0％对5.1％）。
结论：治疗组之间的患者特征大致相似；SITT发起者比MITT发起者有更少的恶化和更低的救护药物使用，由SITT与MITT发起者中IMT的比例更大。医生可能会规定三重双重疗法作为IMT以应对恶化。
方法：描述性，新开始单或多吸入三联疗法的年龄≥15岁的哮喘患者的观察性研究（SITT：糠酸氟替卡松/灭克地铵/维兰特罗[FF/UMEC/VI]，SITT：茚达特罗/格隆溴铵/糠酸莫米松[IND/GLY/MF或MITT）或ICS/LABA使用JMDC/MedicalDataVision（MDV）健康保险数据库，从2021年2月至2022年2月（首次处方日期：索引日期）。患者被分配到三个非相互排斥的队列：A）新的FF/UMEC/VI发起者；B）新的FF/UMEC/VI，IND/GLY/MF,或MITT引发剂；C）新的FF/UMEC/VI，IND/GLY/MF,MITT或ICS/LABA引发剂作为初始维持疗法(IMT)。在治疗开始前12个月（基线期）对患者特征进行描述性评估。
结果：队列A：在新的FF/UMEC/VI引发剂中，12.8％和0.1％（JMDC）以及21.7％和0.9％（MDV）的患者出现≥1次中度和重度加重；52.0％（JMDC）和79.2％（MDV）使用ICS/LABA。队列B：大多数患者开始FF/UMEC/VI和IND/GLY/MF超过MITT（JMDC：91.3％vs8.7％；MDV：67.8％vs32.2％），减少恶化和较低的救护药物使用。队列C：作为IMT的FF/UMEC/VI引发剂的比例更高，与作为IMT的ICS/LABA引发剂相比，指数中度加重（JMDC：17.8％对10.7％；MDV：8.0％对5.1％）。
结论：治疗组之间的患者特征大致相似；SITT发起者比MITT发起者有更少的恶化和更低的救护药物使用，由SITT与MITT发起者中IMT的比例更大。医生可能会规定三重双重疗法作为IMT以应对恶化。
