Division of Pulmonary and Critical Care Medicine, University of Kentucky, Lexington, KY, USA.
US Medical Affairs, GSK, Collegeville, PA, USA.
Adv Ther. 2024 Dec;41(12):4557-4580. doi: 10.1007/s12325-024-02999-3. Epub 2024 Oct 25.
Previous real-world evidence suggests that prompt versus delayed initiation of single-inhaler triple therapy (SITT) with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) following an exacerbation results in improved clinical outcomes for patients with chronic obstructive pulmonary disease (COPD). This prior study was conducted in the first 2 years following FF/UMEC/VI approval, representing early trends. The current updated analysis aims to further elucidate the real-world evidence for FF/UMEC/VI.
This was a retrospective cohort study using the IQVIA PharMetrics Plus database. Patients with COPD initiating SITT with FF/UMEC/VI within 6 months of an exacerbation (index date) were classified as prompt (≤ 30 days following exacerbation) or delayed (31-180 days) initiators. The baseline period comprised the 12 months prior to index. Inverse probability of treatment weighting was used to balance differences in baseline characteristics between cohorts. COPD exacerbations, hospital readmission rates, and healthcare costs were compared between cohorts post-index.
Overall, 5421 patients (prompt, 2057; delayed, 3364) were included. After weighting, baseline characteristics were well balanced between cohorts. For up to 12 months post-index, prompt initiators of FF/UMEC/VI had significantly lower rates of exacerbations per person-year versus delayed initiators (0.74 vs. 1.06; rate ratio 0.70, 95% confidence interval [CI] 0.64-0.77; P < 0.001). A 1-day delay in FF/UMEC/VI initiation was associated with a 0.31% increase in the rate of exacerbations. At 90 days post-index, Kaplan-Meier rates of all-cause (hazard ratio [HR] 0.62, 95% CI 0.45-0.86; P = 0.004) and COPD-related (HR 0.58, 95% CI 0.35-0.98; P = 0.042) hospital readmissions were significantly lower in the prompt versus delayed cohort. Total COPD-related healthcare costs per person per year were significantly lower for patients in the prompt versus delayed cohort.
Healthcare providers should consider the positive impact of prompt FF/UMEC/VI initiation on exacerbation rate, hospital readmission rate, and costs when treating patients with COPD at risk of exacerbations.
先前的真实世界证据表明，在慢性阻塞性肺疾病（COPD）患者急性加重后，与延迟启动相比，氟替卡松维兰特罗/乌美溴铵（FF/UMEC/VI）单吸入三联疗法（SITT）的即时启动可改善患者的临床结局。这项先前的研究是在 FF/UMEC/VI 获得批准后的头 2 年进行的，代表了早期的趋势。目前的更新分析旨在进一步阐明 FF/UMEC/VI 的真实世界证据。
这是一项使用 IQVIA PharMetrics Plus 数据库的回顾性队列研究。在急性加重后 6 个月内（索引日期）开始 SITT 治疗的 COPD 患者，根据是否在急性加重后≤30 天（即时启动）或>30 天（延迟启动）开始治疗进行分类。基线期包括索引日期前的 12 个月。使用逆概率治疗加权法来平衡队列间基线特征的差异。比较指数后两组间 COPD 加重、住院再入院率和医疗保健费用。
总体而言，共纳入 5421 例患者（即时组 2057 例，延迟组 3364 例）。经加权后，两组间基线特征均衡。在索引后长达 12 个月的时间里，与延迟启动者相比，即时启动 FF/UMEC/VI 治疗的患者的 COPD 加重率/人年显著更低（0.74 与 1.06；率比 0.70，95%置信区间[CI]0.64-0.77；P<0.001）。FF/UMEC/VI 启动延迟 1 天，COPD 加重的发生率增加 0.31%。在索引后 90 天，全因（风险比[HR]0.62，95%CI0.45-0.86；P=0.004）和 COPD 相关（HR0.58，95%CI0.35-0.98；P=0.042）住院再入院的 Kaplan-Meier 率在即时组显著低于延迟组。与延迟组相比，每年每例患者 COPD 相关的总医疗保健费用也显著降低。
当治疗有加重风险的 COPD 患者时，医疗保健提供者应考虑即时启动 FF/UMEC/VI 对降低加重率、住院再入院率和成本的积极影响。
