Oga Toru, Ito Risako, Mita Chifuku, Takano Masashi, Requena Gema, Mukai Isao, Yarita Masao
Department of Respiratory Medicine, Kawasaki Medical School, 577, Matsushima, Kurashiki, Okayama, 701-0192, Japan.
Global Real-World Evidence & Health Outcomes Research Japan, GSK, 1-8-1 Akasaka, Minato-ku, Tokyo, 107-0052, Japan.
Respir Investig. 2025 Jul;63(4):569-575. doi: 10.1016/j.resinv.2025.04.017. Epub 2025 May 5.
Real-world evidence of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) use in Japan is limited. This real-world study assessed adherence to FF/UMEC/VI once-daily single-inhaler triple therapy (SITT) versus multiple-inhaler triple therapy (MITT) among patients with asthma in Japan.
Retrospective observational cohort study of patients with asthma initiating FF/UMEC/VI SITT or MITT, using claims data (02/18/2021-02/28/2022, JMDC database). Patients were aged ≥15 years at index (date of FF/UMEC/VI or MITT claim). Outcomes were assessed in two cohorts and weighted using inverse probability of treatment weighting: 1) 'overall cohort' included patients who received FF/UMEC/VI or MITT as initial maintenance therapy (IMT) or as non-IMT (i.e., had previously received inhaled corticosteroid-containing medication during baseline); 2) 'non-IMT cohort' was a sub-cohort of the overall cohort.
proportion of adherent patients (proportion of days covered ≥0.8) in the 3, 6, and 12 months after, and including, index date.
The overall cohort comprised 7228 (FF/UMEC/VI) and 864 (MITT) patients. Of these, 3623 and 735 were included in the FF/UMEC/VI and MITT non-IMT cohort, respectively. At 3 months post-index, a significantly higher proportion of patients were adherent to FF/UMEC/VI (36.4 % [n = 2631]) versus MITT (31.2 % [n = 270]) in the overall cohort (rate ratio [95 % confidence interval], 1.16 [1.05-1.29], p = 0.003, weighted), and FF/UMEC/VI (36.6 % [n = 1326]) versus MITT (28.9 % [n = 213]) in the non-IMT cohort (1.26 [1.12-1.43], p < 0.001). Similar results were observed at 6, and 12 months post-index.
Patients with asthma in Japan who initiated FF/UMEC/VI SITT had significantly better treatment adherence than those who initiated MITT.
糠酸氟替卡松/乌美溴铵/维兰特罗（FF/UMEC/VI）在日本的真实世界证据有限。这项真实世界研究评估了日本哮喘患者中，每日一次单吸入器三联疗法（SITT）与多吸入器三联疗法（MITT）对FF/UMEC/VI的依从性。
利用索赔数据（2021年2月18日至2022年2月28日，JMDC数据库）对开始使用FF/UMEC/VI SITT或MITT的哮喘患者进行回顾性观察队列研究。患者在索引日期（FF/UMEC/VI或MITT索赔日期）时年龄≥15岁。在两个队列中评估结局，并使用治疗权重的逆概率进行加权：1）“总体队列”包括接受FF/UMEC/VI或MITT作为初始维持治疗（IMT）或非IMT的患者（即基线期间曾接受含吸入性糖皮质激素药物治疗）；2）“非IMT队列”是总体队列的一个子队列。
索引日期及之后3、6和12个月内依从患者的比例（覆盖天数比例≥0.8）。
总体队列包括7228名（FF/UMEC/VI）和864名（MITT）患者。其中，FF/UMEC/VI和MITT非IMT队列分别纳入3623名和735名患者。在索引日期后3个月，总体队列中依从FF/UMEC/VI的患者比例（36.4%[n = 2631]）显著高于依从MITT的患者比例（31.2%[n = 270]）（率比[95%置信区间]，1.16[1.05 - 1.29]，p = 0.003，加权），在非IMT队列中，依从FF/UMEC/VI的患者比例（36.6%[n = 1326]）高于依从MITT的患者比例（28.9%[n = 213]）（1.26[1.12 - 1.43]，p < 0.001）。在索引日期后6个月和12个月观察到类似结果。
在日本，开始使用FF/UMEC/VI SITT的哮喘患者的治疗依从性显著优于开始使用MITT的患者。
