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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: 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).)