Search

Emmeline Igboekwe,1 Sumit Verma,2 Rosirene Paczkowski3 1US Medical Affairs, R&D Global Medical, GSK, Durham, NC, USA; 2STATinMED, LLC, Dallas, TX, USA; 3Value Evidence and Outcomes, R&D Global Medical, GSK, Collegeville, PA, USACorrespondence: Rosirene Paczkowski, GSK, Upper Providence UP4410, 1250 South Collegeville Road, Collegeville, PA 19426, USA, Tel +1 904.832.7934, Email rosirene.x.paczkowski@gsk.comPurpose: Chronic obstructive pulmonary disease (COPD) and asthma are associated with chronic inflammation of the respiratory tract; despite some overlap of symptoms, they are considered separate disorders. Triple therapy is recommended for patients with COPD and asthma whose symptoms remain uncontrolled despite dual therapy. There are limited real-world studies evaluating outcomes among patients with COPD and asthma who are receiving inhaled triple therapy. This United States (US)-based real-world study aimed to evaluate clinical and economic outcomes among patients with COPD and asthma receiving single-inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol [FF/UMEC/VI]).Patients and Methods: Retrospective pre-post study using claims data from the Optum Clinformatics® database. Patients with COPD and asthma were indexed on the first date of FF/UMEC/VI prescription (1 October 2017– 31 March 2019). Each patient acted as their own control. Patients were required to have continuous health plan enrollment for 12 months prior to (pre-treatment) and following (post-treatment) index. Exacerbations, all-cause and COPD-related healthcare resource utilization, and costs were compared before and after FF/UMEC/VI initiation.Results: Overall, 2743 patients were included (mean age: 71 years; 64% female). Cardiovascular disease was the most prevalent comorbidity during both the pre- and post-treatment periods (90% for both periods). There was a lower proportion of patients with ≥ 1 COPD exacerbation or ≥ 1 asthma exacerbation post-treatment versus pre-treatment (51% vs 57%, p< 0.0001, and 22% vs 32%, p< 0.0001, respectively). Fewer patients had ≥ 1 all-cause office visit post-treatment versus pre-treatment (99.3% vs 99.7%, p=0.0329); more patients had ≥ 1 COPD-related office visit post-treatment versus pre-treatment (89.6% vs 87.5%, p=0.0035). Total all-cause healthcare costs were significantly higher post-treatment versus pre-treatment (&dollar;72,809 vs &dollar;63,734, p< 0.0001). The driver of increased costs appeared to be primarily non-COPD-related (COPD-related costs: post-treatment &dollar;27,779 vs pre-treatment &dollar;25,081, p=0.0062).Conclusion: FF/UMEC/VI reduced exacerbations among patients with COPD and asthma in a real-world setting in the US.Plain Language Summary: Chronic obstructive pulmonary disease (COPD) and asthma are different respiratory conditions that have similar symptoms. Patients can be diagnosed with both conditions at the same time. A flare-up of COPD or asthma symptoms can lead to a lung attack, which can result in hospitalization and a considerable decline in patient health as well as being associated with high healthcare resource use and costs.An inhaler with three different medicines (fluticasone furoate, umeclidinium, and vilanterol; shortened to FF/UMEC/VI) can be prescribed for patients with COPD or asthma. This study was done to assess how FF/UMEC/VI (taken using a single inhaler) affected lung attacks as well as healthcare resource use and costs among patients who have been diagnosed with both COPD and asthma.This study found that fewer patients experienced a lung attack in the first 12 months after starting FF/UMEC/VI compared with the 12 months before starting FF/UMEC/VI. A lower proportion of patients had ≥ 1 medical office visit, ≥ 1 hospital admission, or ≥ 1 emergency room visit after starting FF/UMEC/VI compared with before FF/UMEC/VI. Many patients in this study had other medical conditions such as heart and kidney disease as well as their asthma and COPD. Although total healthcare costs were higher for patients after they had started FF/UMEC/VI compared with before, this appeared to be mainly due to patients’ other medical conditions, besides from COPD.FF/UMEC/VI may be able to reduce future symptom flare-ups and lung attacks in patients who have been diagnosed with both COPD and asthma.Keywords: asthma, chronic obstructive pulmonary disease, exacerbation, HCRU, real-world, triple therapy

Michael Bogart,1 Guillaume Germain,2 François Laliberté,2 Malena Mahendran,2 Mei Sheng Duh,3 Kristi DiRocco,4 Stephen G Noorduyn,5,6 Rosirene Paczkowski,7 Ronald Balkissoon8 1U.S. Value Evidence and Outcomes, R&D U.S., GSK, Research Triangle Park, Durham, NC, USA; 2Groupe d’Analyse, Ltée, Montréal, QC, Canada; 3Analysis Group, Inc., Boston, MA, USA; 4U.S. Medical Affairs, GSK, Collegeville, PA, USA; 5Global Value Evidence and Outcomes, GSK, Mississauga, ON, Canada; 6Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; 7Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 8National Jewish Health, Denver, CO, USACorrespondence: Kristi DiRocco, U.S. Medical Affairs, GSK, Collegeville, PA, USA, Tel +1 610-412-7175, Email kristi.k.dirocco@gsk.comPurpose: Real-world asthma control data among patients initiating fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) are limited. This study assessed rescue medication use and asthma-related exacerbations in patients with asthma before and after initiating single-inhaler FF/UMEC/VI using administrative claims data.Patients and Methods: This retrospective, pre-post cohort study analyzed data from the IQVIA PharMetrics Plus database (September 18, 2016‒March 31, 2020). Patients aged ≥ 18 years that had ≥ 1 dispensing of single-inhaler FF/UMEC/VI 100/62.5/25 mcg (first dispensing = index date), ≥ 12 months of continuous health insurance enrollment prior to (pre-treatment) and following (post-treatment) FF/UMEC/VI initiation and ≥ 1 diagnosis of asthma during the pre-treatment period or on the index date were included. The primary endpoint was the number of oral corticosteroid (OCS) dispensings per patient per year during pre- and post-treatment periods. Secondary endpoints included asthma-related exacerbation rates and short-acting β2-agonist (SABA) use. Comparisons between pre- and post-treatment periods were made using risk and rate ratios.Results: Overall, 890 patients with asthma initiating treatment with FF/UMEC/VI were included. The most recently dispensed controller medications prior to FF/UMEC/VI initiation were inhaled corticosteroids/long-acting β2-agonists (33.5%) and leukotriene modifiers (33.0%). Patients had a 29% reduction in the number of OCS dispensings (rate ratio [95% confidence interval (CI)]: 0.71 [0.65, 0.77], P < 0.001) during post-treatment versus pre-treatment, with a 23% reduction in the proportion of patients with ≥ 1 OCS dispensing post-treatment (risk ratio [95% CI]: 0.77 [0.73, 0.82], P < 0.001). Significant reductions in rates (rate ratio [95% CI]) of asthma-related exacerbations (0.59 [0.52, 0.67], P < 0.001) and SABA use (0.80 [0.74, 0.86], P < 0.001) were also observed.Conclusion: In this real-world study, patients with asthma had significantly lower OCS use, asthma-related exacerbations, and SABA use following treatment initiation with FF/UMEC/VI compared with their pre-treatment period. These results suggest better asthma control following initiation of FF/UMEC/VI in a routine clinical practice setting.Keywords: oral corticosteroids, rescue medication use, asthma control, FF/UMEC/VI, asthma exacerbations

Heather L Gelhorn,1 Jiat-Ling Poon,1 Evan W Davies,2 Rosirene Paczkowski,3 Sarah E Curtis,3 Kristina S Boye3 1Outcomes Research, Evidera, Bethesda, MD, USA; 2Outcomes Research, Evidera, London, UK; 3Global Patient Outcomes and Real World Evidence, Eli Lilly and Company, Indianapolis, IN, USA Objective: To use a discrete choice experiment (DCE) to evaluate preferences for the actual treatment features and overall profiles of two injectable glucagon-like peptide-1 receptor agonists (dulaglutide and liraglutide) among patients with type 2 diabetes mellitus (T2DM) in the UK.Methods: In-person interviews were conducted in the UK to administer a DCE to patients with self-reported T2DM, naïve to treatment with injectable medications. The DCE examined six attributes of T2DM treatment each described by two levels: “dosing frequency,” “hemoglobin A1c change,” “weight change,” “type of delivery system,” “frequency of nausea,” and “frequency of hypoglycemia.” Part-worth utilities were estimated using random effects logit models and were used to calculate relative importance (RI) values for each attribute. A chi-square test was used to determine differences in preferences for dulaglutide versus liraglutide profiles.Results: A total of 243 participants [mean age: 60.5 (standard deviation 10.9) years; 76.1% male; mean body mass index: 29.8 (standard deviation 5.4) kg/m2] completed the study. RI values for the attributes in rank order were: “dosing frequency” (41.6%), “type of delivery system” (35.5%), “frequency of nausea” (10.4%), “weight change” (5.9%), “hemoglobin A1c change” (3.6%), and “frequency of hypoglycemia” (3.0%). Significantly more participants preferred the dulaglutide profile (83.1%) compared with the liraglutide profile (16.9%; P

Introduction: Escalation to single- or multiple-inhaler triple therapy (SITT; MITT) is a recommended option for patients with asthma who remain uncontrolled by medium-dose inhaled corticosteroid/long-acting β 2 -agonist; however, characterization of elderly users of triple therapy is limited. This real-world cohort study describes demographics and clinical characteristics of elderly patients with asthma with and without comorbid chronic obstructive pulmonary disease (COPD) who are new users of triple therapy, and asthma treatment patterns preceding triple therapy initiation., Methods: This retrospective cohort study used administrative claims data from the Optum Clinformatics Data Mart database. Eligible patients were ≥ 65 years of age with asthma or with asthma and comorbid COPD who initiated either triple therapy with single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI; 100/62.5/25 μg) or MITT between September 18, 2017 and September 30, 2020. Demographics, clinical characteristics, healthcare resource utilization, healthcare costs, and asthma treatment patterns were described in the 12-month period before triple therapy initiation (baseline period)., Results: In total, 15,557 patients were included. Among FF/UMEC/VI initiators with asthma (N = 635) mean age was 73.3 years and 66.6% were female. During the baseline period, > 75% of patients used controller therapy, > 92% used rescue medications, 27.9% experienced ≥ 1 asthma-related exacerbation, with mean annual exacerbation rate of 0.42, and mean all-cause healthcare costs were $23,407. Patients with asthma initiating MITT and patients with asthma and comorbid COPD initiating FF/UMEC/VI or MITT had similar characteristics, healthcare resource utilization, healthcare costs, and asthma treatment patterns to FF/UMEC/VI initiators with asthma., Conclusions: Triple therapy is often initiated following use of other asthma controller medications in real-world practice. Substantial rescue medication use and high disease and economic burden among this elderly patient population suggest that their asthma was not adequately controlled prior to triple therapy initiation. This retrospective study provides an early profile of elderly patients with asthma in the USA., Competing Interests: Declarations. Conflict of Interest: Russell A. Settipane has received compensation from GSK for speaking, advisory board services, and serving as an independent contractor for clinical trial research. Guillaume Germain, Francois Laliberté, Malena Mahendran, Annalise Hilts, and Mei Sheng Duh are employees of Analysis Group, Inc., a consulting company that received research funds from GSK to conduct this study. Rosirene Paczkowski and Emmeline Burrows are employed by GSK and hold financial equities in GSK. ELLIPTA and DISKUS are owned by or licensed to the GSK Group of companies. Clinformatics is a trademark of OptumInsight, Inc. Ethical Approval: This study complied with all applicable laws regarding subject privacy. No direct subject contact or primary collection of individual human subject data occurred. Study results were in tabular form and aggregate analyses that omit subject identification; therefore informed consent and ethics committee or institutional review board approval are not required. Any publications and reports will not include subject identifiers. Furthermore, this study used de-identified data that complied with the requirements of the Health Insurance Portability and Accountability Act (HIPAA)., (© 2025. The Author(s).)

Introduction: Chronic obstructive pulmonary disease (COPD) is associated with exacerbations which can reduce quality of life and increase mortality. Single-inhaler triple therapy (SITT) is recommended for maintenance treatment of COPD among patients experiencing exacerbations despite dual-therapy use. This real-world comparative effectiveness study compared the impact of SITTs, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), and budesonide/glycopyrrolate/formoterol fumarate (BUD/GLY/FORM), on COPD exacerbations and mortality., Methods: Medicare Fee-for-Service (FFS) patients with COPD initiated on FF/UMEC/VI or BUD/GLY/FORM were identified from the Komodo Research healthcare claims dataset (01/01/2016-12/31/2023). Overlap weighting based on high-dimensional propensity scores evaluated from patient characteristics was used to adjust for baseline confounding. Primary outcome was annualized rate of moderate-severe COPD exacerbations (per patient-year; PPY) compared using rate ratios (RRs) with 95% confidence intervals (CIs) from weighted Poisson regression models. Secondary and exploratory outcomes were risk of moderate-severe COPD exacerbations and all-cause mortality, respectively, evaluated using Kaplan-Meier analysis and hazard ratios (HR) with 95% CIs from Cox proportional hazard models. A secondary analysis was conducted among a mutually exclusive population with Medicare Advantage, Medicaid, or commercial insurance., Results: Overall, 32,312 FF/UMEC/VI and 12,230 BUD/GLY/FORM Medicare FFS patients were included. After weighting, median follow-up was 9 months. Compared with BUD/GLY/FORM, FF/UMEC/VI users had a 12% lower rate of annualized moderate-severe COPD exacerbations [0.80 and 0.91 PPY; RR (95% CI): 0.88 (0.85-0.92); P < 0.001] and a 10% lower risk of moderate-severe exacerbations at 12 months post-initiation [HR (95% CI): 0.90 (0.87-0.93); P < 0.001], driven by moderate exacerbations. FF/UMEC/VI compared with BUD/GLY/FORM users had 11% lower risk of all-cause mortality at 12 months post-initiation [5.6% vs. 6.4%; HR (95% CI): 0.89 (0.80-0.98); P = 0.020]. Results were consistent among patients with Medicare Advantage, Medicaid, or commercial insurance., Conclusions: In this real-world comparative effectiveness study, FF/UMEC/VI was associated with significantly lower rate and risk of COPD exacerbations than BUD/GLY/FORM., Competing Interests: Declarations. Conflict of Interest: David Mannino is a consultant for AstraZeneca, the COPD Foundation, Genentech, GSK, Regeneron, and Up-to-Date. David Mannino is also an expert witness on behalf of people suing the tobacco and vaping industries. Stephen Weng, Sergio Forero-Schwanhaeuser, Chris H Compton, Stephen G Noorduyn, and Rosirene Paczkowski are employees of GSK and/or hold financial equities in GSK. Stephen G Noorduyn is also a PhD candidate at McMaster University. Guillaume Germain, Julien Boudreau, Anabelle Tardif-Samson, François Laliberté, and Patrick Gravelle are employees of Groupe d’analyse, which received funding from GSK to conduct this study. Ethical Approval: This study complied with all applicable laws regarding patient privacy, as described in the Declaration of Helsinki. No direct patient contact or primary collection of individual human patient data has occurred in this study. This study used existing, fully de-identified data that complied with the requirements of the Health Insurance Portability and Accountability Act and the patient(s) cannot be identified, directly or through identifiers. Study results were in tabular form and aggregate analyses that omit patient identification; therefore, informed consent, ethics committee or Institutional Review Board approval were not required., (© 2024. The Author(s).)

Introduction: The clinical benefits of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) have been demonstrated in clinical trials. There is limited evidence regarding the effectiveness and economic outcomes associated with FF/UMEC/VI use in US clinical practice. This real-world study assessed asthma-related exacerbations, healthcare resource utilization (HRU), and healthcare costs among a Medicare Advantage-insured population before and after initiation of FF/UMEC/VI in patients with asthma previously treated with an inhaled corticosteroid/long-acting β 2 -agonist (ICS/LABA)., Methods: De-identified data were obtained from the Komodo Health database (01/01/2016-12/31/2023) for adults with asthma who received prior ICS/LABA treatment and had ≥ 12 months of continuous Medicare Advantage coverage both pre- and post-FF/UMEC/VI initiation (index date). Rates of asthma-related exacerbations and HRU were compared using rate ratios (RR) from Poisson regressions. Healthcare costs were calculated per patient per year (PPPY) and compared using mean cost differences from generalized linear models., Results: In total, 2598 Medicare Advantage-insured patients who initiated FF/UMEC/VI for asthma were included. The mean ± SD age was 67.9 ± 12.3 years; 75.5% were female. The rate of overall asthma-related exacerbations was 31% lower in the post- versus pre-initiation period (RR 0.69; 95% CI 0.65, 0.73; p < 0.001) and included a 24% lower rate of inpatient/emergency department (IP/ED)-defined exacerbations (RR 0.76; 95% CI 0.68, 0.85; p < 0.001) and a 34% lower rate of systemic corticosteroid (SCS)-defined exacerbations (RR 0.66; 95% CI 0.61, 0.71; p < 0.001). Asthma-related ED visits (RR 0.69; 95% CI 0.60, 0.80; p < 0.001) and asthma-related outpatient (OP) visits (RR 0.77; 95% CI 0.71, 0.84; p < 0.001) were both lower, and the mean reduction in cost was $411 PPPY (95% CI $575, $248; p < 0.001), after FF/UMEC/VI initiation., Conclusions: Initiation of FF/UMEC/VI after ICS/LABA treatment among Medicare Advantage-insured patients with asthma was associated with reduced rates of asthma-related exacerbations, ED and OP visits, and healthcare costs, highlighting the benefits of therapy escalation among this patient population., Competing Interests: Declarations. Conflict of Interest: Alan P. Baptist reports grant support from GSK, AstraZeneca, and Teva. Guillaume Germain, Jacob Klimek, François Laliberté, and Robert C. Schell are employees of Analysis Group, a consulting company that has received research funds from GSK to conduct this study. Sergio Forero-Schwanhaeuser, Alison Moore, Stephen G. Noorduyn, and Rosirene Paczkowski are employees of GSK and hold financial equities in GSK. Stephen G. Noorduyn is also a PhD candidate at McMaster University. Ethical Approval: The study was considered exempt research under 45 CFR § 46.104(d)(4) as it involved only the secondary use of data that were de-identified in compliance with the Health Insurance Portability and Accountability Act (HIPAA): specifically, 45 CFR § 164.514., (© 2024. The Author(s).)

Introduction: Previously, adherence and persistence to treatment have been shown to improve outcomes among patients with chronic obstructive pulmonary disease (COPD). This study aimed to evaluate adherence and persistence to single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI; one inhalation, once-daily) compared with budesonide/glycopyrrolate/formoterol fumarate (BUD/GLY/FOR; two inhalations, twice-daily) among patients with COPD in the USA., Methods: This retrospective weighted cohort study used claims data from the IQVIA PharMetrics ® Plus Database from October 1, 2019 to March 31, 2023, to identify patients with COPD newly initiating FF/UMEC/VI or BUD/GLY/FOR. Index date was the first pharmacy claim for FF/UMEC/VI or BUD/GLY/FOR on or after October 1, 2020. The longest follow-up period was 12 months. Inverse probability of treatment weighting was used to balance baseline characteristics between cohorts. Adherence was measured as mean proportion of days covered (PDC); the proportion of patients with PDC ≥ 0.5 and PDC ≥ 0.8 was also assessed. Persistence was assessed as time to treatment discontinuation using Kaplan-Meier rates., Results: Overall, 8912 and 2685 patients were included in the FF/UMEC/VI and BUD/GLY/FOR cohorts, respectively. After weighting, mean age and proportion of patients with Medicare Advantage insurance was 64.62 years and 40.0% in the FF/UMEC/VI cohort and 63.96 years and 36.1% in the BUD/GLY/FOR cohort. At 6 months post-index, mean PDC was greater in the FF/UMEC/VI versus the BUD/GLY/FOR cohort (0.65 versus 0.59; P < 0.001). A significantly greater proportion of patients in the FF/UMEC/VI versus the BUD/GLY/FOR cohort had PDC ≥ 0.8 (45.6% versus 34.5%; P < 0.001) and PDC ≥ 0.5 (71.8% versus 64.3%; P < 0.001). Results were consistent at 12 months post-index. When a 30-day gap was used to define treatment discontinuation, the FF/UMEC/VI cohort had statistically significantly greater treatment persistence versus the BUD/GLY/FOR cohort at all time points., Conclusion: In this study, patients initiating FF/UMEC/VI had significantly greater adherence and persistence to treatment than patients initiating BUD/GLY/FOR., Competing Interests: Declarations. Conflict of Interest: Corinne Young is an employee of the Association of Pulmonary Advanced Practice Providers and Clinical Services. Lydia Y. Lee was a university worker hired by GSK at the time of this study. Lydia Y. Lee is currently an employee of Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA (Boehringer Ingelheim has no connection to this study). Kristi K. DiRocco, Stephen G. Noorduyn, and Rosirene Paczkowski are employees of GSK and hold financial equities in GSK. Stephen G. Noorduyn is also a PhD candidate at McMaster University, Hamilton, ON, Canada. Guillaume Germain, Jacob Klimek, François Laliberté, and Dominique Lejeune are employees of Groupe d'analyse, Ltée, Montréal, QC, Canada, which received funding from GSK to conduct this study. Ethical Approval: The data reported in this publication are contained in a database owned by IQVIA and contain proprietary elements. Therefore, these data cannot be broadly disclosed or made publicly available at this time. The disclosure of this data to third-party clients assumes certain data security and privacy protocols are in place and that the third-party client has executed IQVIA’s standard license agreement, which includes restrictive covenants governing the use of the data. Permission was obtained from IQVIA to use the data. This study complied with all applicable laws regarding subject privacy. No direct subject contact or primary collection of individual human subject data occurred in this study. This study used existing, fully de-identified data that complied with the requirements of the Health Insurance Portability and Accountability Act, and the subject(s) cannot be identified, directly or through identifiers. The study results are in tabular form and aggregate analyses that omit subject identification. As per Title 45 of CFR, Part 46 ( http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101 ), informed consent, ethics committee, or institutional review board review were not needed, as the claims data analysis of our study was a retrospective analysis of existing data (hence no patient intervention or interaction), and no patient-identifiable information was included in the claims dataset., (© 2024. The Author(s).)

Introduction: 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., Methods: 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., Results: 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., Conclusion: 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., (© 2024. The Author(s).)

Introduction: Triple therapy (fluticasone furoate/umeclidinium/vilanterol; FF/UMEC/VI) has been shown to improve symptoms and reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. This real-world study compared exacerbation rates and healthcare resource utilization (HCRU) before and after initiation of FF/UMEC/VI in patients with COPD previously treated with inhaled corticosteroid (ICS)/long-acting β 2 -agonist (LABA)., Methods: This retrospective cohort study included commercial and Medicare Advantage with Part D administrative claims data from September 01, 2016, to March 31, 2020, of patients diagnosed with COPD. The index date was the date of the first FF/UMEC/VI claim (September 2017-March 2019). The 12 months prior to index (baseline) were used to assess patient characteristics and outcomes; the 12 months following index (follow-up) were used to assess study outcomes. All patients had ≥ 30 consecutive days' supply of any ICS/LABA dual therapy during the 12 months prior to FF/UMEC/VI initiation. Subgroup analyses included patients with ≥ 30 consecutive days' supply of budesonide/formoterol (BUD/FORM) during baseline. Analyses of patients with ≥ 1 COPD exacerbation during baseline were reported as well., Results: The overall population included 1449 patients (mean age 70.75 years; 54.18% female), of whom 540 were patients in the BUD/FORM subgroup. Significantly fewer patients experienced any exacerbation during follow-up versus baseline (overall population 53.49% vs 62.59%; p < 0.001; BUD/FORM subgroup 55.00% vs 62.41%; p = 0.004). Effects on exacerbation reduction were more pronounced among patients with ≥ 1 exacerbation during baseline. Lower COPD-related HCRU was observed during the follow-up compared with baseline for both the overall population and the BUD/FORM subgroup., Conclusion: Patients with COPD treated with ICS/LABA during baseline, including patients specifically treated with BUD/FORM and those with a history of ≥ 1 exacerbation, had fewer COPD exacerbations and lower COPD-related HCRU after initiating FF/UMEC/VI., (© 2024. The Author(s).)