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Background Patients with severe asthma often require oral corticosteroid (OCS) treatment. Clinical trials have demonstrated that mepolizumab can reduce OCS dependence, but real-world data are limited. Objective To evaluate the impact of mepolizumab on OCS use, asthma exacerbations, and asthma exacerbation-related costs in a real-world setting. Methods This retrospective cohort study (GSK ID: 209642; HO-19-19597) analyzed data from the MarketScan® Commercial database (identification period: November 2015-September 2017). Patients were ≥12 years old at mepolizumab initiation (index date), had a baseline asthma diagnosis, and received ≥2 mepolizumab administrations in the first 6 months of follow-up. OCS use, asthma exacerbation rate, and asthma exacerbation-related costs were assessed in the 12-months before (baseline) and 12-months after (follow-up) mepolizumab initiation. Results Mepolizumab was associated with a 14.7% reduction in the proportion of patients with ≥1 OCS claim from baseline to follow-up (93.4% vs 79.7%; P

Chad Moretz,1 Beth Hahn,1 John White,2 Alyssa Goolsby Hunter,2 Breanna Essoi,2 Caitlin Elliott,2 Riju Ray3 1US Value Evidence & Outcomes, GlaxoSmithKline, Research Triangle Park, NC, USA; 2Optum, Eden Prairie, MN, USA; 3US Medical Affairs, GlaxoSmithKline, Research Triangle Park, NCCorrespondence: Beth HahnGSK, 5 Moore Drive, Research Triangle Park, Durham, NC, USATel +1 919 274 0660Email beth.a.hahn@gsk.comBackground: Long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) provide greater improvements in lung function and symptoms than inhaled corticosteroid (ICS)/LABA in patients with chronic obstructive pulmonary disease (COPD). This study evaluated symptom burden and Global Initiative for Obstructive Lung Disease (GOLD) categorization among patients who recently initiated umeclidinium/vilanterol (UMEC/VI; LAMA/LABA) or fluticasone propionate/salmeterol (FP/SAL; ICS/LABA) single-inhaler dual therapy.Methods: COPD-diagnosed Medicare Advantage enrollees aged ≥ 65 years were identified from the Optum Research Database (ORD). Eligible patients had ≥ 1 pharmacy claim for UMEC/VI or FP/SAL in the 6-month period before sample identification, with no evidence of triple therapy (ICS/LAMA/LABA), asthma, or lung cancer. Symptom burden was assessed via cross-sectional surveys using the COPD Assessment Test (CAT) and modified Medical Research Council (mMRC) dyspnea scale. Patients were classified into GOLD categories using patient-reported symptoms and claims-based exacerbation history. Treatment groups were balanced on potential confounders using inverse probability of treatment weighting (IPTW). CAT and mMRC scores were analyzed with generalized linear regression models using IPTW propensity scores.Results: The final analytic sample included 789 respondents (UMEC/VI: N=392; FP/SAL: N=397). Approximately 66% patients were classified as GOLD B when assessing symptoms with CAT and mMRC together, or CAT alone; more patients were classified as GOLD A (∼ 40%) than GOLD B (∼ 36%) using mMRC alone. Proportions of patients in each GOLD group were similar between treatment cohorts. Post-IPTW multivariable modeling showed similar symptom burden between treatment groups.Conclusion: After controlling for baseline characteristics, symptom burden was similar between patients receiving UMEC/VI or FP/SAL. GOLD classification using mMRC produced more conservative results compared with CAT, potentially underestimating patient symptoms. Many patients receiving FP/SAL were classified as GOLD A or B, despite GOLD recommending non-ICS-containing therapy in these patients. These findings support the need for routine assessment of symptoms in patients with COPD.Keywords: COPD, fluticasone propionate/salmeterol, umeclidinium/vilanterol, CAT, mMRC, GOLD group

Rationale Results from clinical trials in patients with severe eosinophilic asthma have demonstrated that mepolizumab is well tolerated and is associated with improved asthma control as evidenced by reductions in both exacerbations and maintenance oral corticosteroid use, and improvements in lung function, asthma control, and quality of life. However, real-world data are lacking on the impact of mepolizumab treatment. Objective To assess the effect of mepolizumab treatment on the rate of asthma exacerbations and asthma exacerbation-related costs in a real-world setting. Methods This retrospective cohort study (GSK ID: 209017; HO-18-19168) analyzed data from patients with severe asthma ≥12 years of age at mepolizumab treatment initiation (index date) with ≥12 months pre- (baseline) and post-index (follow-up) data from a commercial claims database (patients were identified from November 1, 2015 to March 31, 2017). Asthma exacerbations (primary objective) and asthma exacerbation-related costs (secondary objective) in the baseline and follow-up periods were compared. Other analyses included the number of mepolizumab administrations and the use of concomitant asthma medications. Results Data were analyzed from 346 patients. Mepolizumab significantly reduced the proportion of patients with any exacerbation and exacerbations requiring hospitalization, compared with baseline. Significant reductions in the rate of all exacerbations of 38.4% (from 2.68 to 1.65 events/patient/year; P

To assess patient- and physician-reported reasons for discontinuing biologic therapy among patients with severe asthma from a real-world US cohort.This retrospective analysis surveyed US physicians and their patients with severe asthma who were receiving/had previously received biologic therapy between August and December 2019. Physicians managing ≥3 patients with asthma per month completed surveys on disease management, demographics, exacerbation history, and biologic adherence for eligible patients. Patients could voluntarily complete a questionnaire, providing perceptions of their disease and treatment.117 physicians completed case reports for 285 patients; 85 patients had discontinued biologic therapy. Physicians (in/i = 85) and patients (in/i = 64) reported patient request (28.2% and 46.9%), shortness of breath (45.9% and 23.4%), other chronic respiratory symptoms (29.4% and 10.9%), cost/reimbursement (17.7%/9.4% and 20.3%/7.8%), and exacerbations (25.9% and 10.9%) among the main reasons for biologic discontinuation. Patients who continued biologic therapy were older (mean age 47.6 years) than those who discontinued (43.8 years), and were more likely to have ≥2 exacerbations in the previous year (52.5% vs 35.3%), allergic rhinitis (70.0% vs 62.4%), or chronic rhinosinusitis (30.0% vs 12.9%). Side effects were cited as reasons by only 15.3% and 7.8% of physicians and patients, respectively.The most common reasons given for discontinuation of biologic therapy were lack of symptom control, exacerbations, cost, and patient request. These data highlight the complexity of care for this patient group and the need for ongoing, regular assessment of common challenges to biologic continuation and reasons for discontinuation, including both clinical and non-clinical factors.

Background This was the first real-world head-to-head study comparing inhaled long-acting muscarinic antagonist/long-acting β2-agonist fixed-dose combination treatments as maintenance therapy. Methods Retrospective observational study including commercial, Medicare Advantage with Part D or Part D-only enrollees aged ≥40 years from the Optum Research Database. Patients initiated umeclidinium/vilanterol (UMEC/VI) or tiotropium bromide/olodaterol (TIO/OLO) between June 1, 2015 and November 30, 2016 (index date) with 12 months of pre- and post-index continuous enrollment. Outcomes were modeled following the inverse probability of treatment weighting. The primary endpoint, rescue medication use, was modeled using weighted ordinary least squares regression with bootstrapped variance estimation. Intent-to-treat analysis evaluated non-inferiority and superiority of UMEC/VI to TIO/OLO with thresholds of 0.30 and 0 units, respectively. On-treatment sensitivity analysis evaluated the superiority of UMEC/VI to TIO/OLO for rescue medication use. The secondary endpoint, medication adherence (proportion of days covered [PDC]≥80%), was evaluated using weighted logistic regression. Post hoc weighted Cox proportional hazards regression analysis evaluated escalation to multiple inhaler triple therapy (MITT). Results The study population included 14,324 patients; 9549 initiated UMEC/VI and 4775 initiated TIO/OLO. During the 12-month post-index period, UMEC/VI initiators used 0.16 fewer adjusted mean units of rescue medication than TIO/OLO initiators (95% CI: -0.28, -0.04), meeting pre-specified non-inferiority (P

Introduction Many patients with chronic obstructive pulmonary disease (COPD) prescribed long-acting muscarinic antagonist (LAMA) monotherapy remain symptomatic. This multivariable analysis of a previously reported claims-linked, cross-sectional survey assessed symptom burden measured by the COPD assessment test (CAT) in patients treated with LAMA monotherapy. Methods Eligible patients aged ≥ 40 years with COPD (≥ 2 International Classification of Diseases-10th Revision-Clinical Modification [ICD-10-CM] diagnosis codes ≥ 30 days apart during the 12-month baseline period) and ≥ 2 claims for LAMA monotherapy in the latter half of the baseline period were identified using claims data from the Optum Research Database. Patients completed a survey and 7-day daily diary; baseline clinical characteristics and resource utilization were assessed from claims data. Association between symptom burden and baseline characteristics was assessed using generalized linear regression modeling with normal distribution and identity link. Results Overall, 433 patients prescribed LAMA monotherapy with claims-linked survey and diary data were included in the analysis. Most patients (85.5%) had a mean CAT score ≥ 10; 39.0% had scores ≥ 21. Overall, the factors most related to a clinically meaningful increase in CAT score (≥ 2 points) were being diagnosed with COPD for > 5 years and being a current smoker (2.25 points, P = 0.003 and 2.22 points, P = 0.025, respectively). Conclusions Results demonstrate that many patients with COPD receiving LAMA monotherapy remain symptomatic, especially those diagnosed > 5 years ago or those who continue to smoke. Use of patient-reported outcomes such as the CAT should be considered part of routine visits for patients with COPD. Funding GlaxoSmithKline (GSK study number 205862 [HO-16-16642]). Electronic supplementary material The online version of this article (10.1007/s41030-019-00098-1) contains supplementary material, which is available to authorized users.

Introduction To address the burden of chronic obstructive pulmonary disease (COPD), the Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends treatment according to classification of patients by symptom severity and exacerbation risk. This post hoc analysis of a previously reported claims-linked, cross-sectional survey [study 205862 (HO-16-16642)] classified patients with COPD receiving long-acting muscarinic antagonist (LAMA) monotherapy based on the GOLD 2017 categories. Methods Eligible patients who were ≥ 40 years of age, with ≥ 2 claims with International Classification of Diseases-10th Revision-Clinical Modification COPD diagnosis codes J40–J44 ≥ 30 days apart during the 12-month baseline period, and ≥ 2 claims for LAMA monotherapy in the 6 months prior to identification, were identified using claims data from the Optum Research Database. Patients completed a survey assessing modified Medical Research Council (mMRC) Dyspnea Scale and COPD Assessment Test (CAT) scores and demographics; clinical characteristics were assessed from claims and survey data, while exacerbation history was assessed from claims data. GOLD symptom severity classifications were low (groups A and C) for patients with low scores on both the CAT and mMRC scales (scores of

Background: Real-world data on the characteristics and burden of disease among patients with asthma before receiving asthma-specific biologics would improve the understanding of the use of these therapies in a clinical setting. Currently, limited data are available on the use of mepolizumab and omalizumab for the treatment of asthma. Objective: To determine the characteristics and disease burden among patients with asthma before initiating treatment with mepolizumab or omalizumab. Methods: This was a retrospective cohort analysis of commercial and Medicare Advantage Plan members from a medical claims database with a new claim for mepolizumab or omalizumab between January 1, 2015, and March 31, 2017 (GSK ID: HO-17‐18283). Eligible patients had a diagnosis of asthma and continuous enrollment in the health plan, with clinical and pharmacy benefits for 12 months before initiating asthma-specific biologic treatment (baseline period), and no diagnosis of chronic idiopathic urticaria during the baseline period. Patient characteristics, exacerbations, and asthma-related health care resource utilization and costs were assessed during the baseline period. Results: Overall, 188 and 901 patients prescribed mepolizumab and omalizumab, respectively, were included. In the 12 months before initiating asthma-specific biologic therapy, the patients prescribed mepolizumab were older, had higher blood eosinophil counts, more-frequent exacerbations (2.9 versus 2.0 exacerbations/year; p < 0.001), and more inhaled corticosteroid and systemic corticosteroid use compared with those prescribed omalizumab. Overall, asthma-related health-care resource utilization and costs were similar across both treatment cohorts, although patients prescribed mepolizumab had more pharmacy fills, higher pharmacy costs, and lower clinic costs compared with patients prescribed omalizumab (20.8 versus 16.9 fills, $4504 versus $3102, and $1816 versus $2709, respectively; all p < 0.001). Conclusion: In the 12 months before initiating asthma-specific biologic therapy, the patients prescribed mepolizumab may have a greater disease burden than those prescribed omalizumab. Overall, health-care resource utilization and costs were broadly similar across both treatment cohorts.

Introduction Symptom burden in inadequately controlled chronic obstructive pulmonary disease (COPD) considerably impacts quality of life, healthcare resource utilization (HCRU) and associated costs. This claims-linked cross-sectional survey study assessed symptom burden and HCRU among a prevalent population of COPD patients prescribed long-acting muscarinic antagonist (LAMA) monotherapy. Methods Patients were identified using claims data from the Optum Research Database. Eligible patients were aged ≥ 40 years with 12 months’ continuous enrollment in a US health plan, ≥ 2 medical claims containing COPD diagnosis codes ≥ 30 days apart, and ≥ 2 claims for LAMA monotherapy in the latter half of the 12-month sample identification period. Patients were mailed a cross-sectional survey assessing patient-reported outcomes (PROs) [COPD assessment test (CAT) and modified medical research council dyspnea scale (mMRC)], clinical characteristics, smoking history, and demographics. Patients also completed the Exacerbations of Chronic Pulmonary Disease Tool (EXACT-PRO) daily diary for 7 days. HCRU was assessed from claims data. Results The study included 433 patients with a self-reported healthcare provider COPD diagnosis, and both claims-based and self-reported LAMA monotherapy treatment (mean age 71.0 years; 59.8% female). Most patients (85.5%) reported a high symptom burden (CAT score ≥ 10), 45.5% had high levels of dyspnea (mMRC grade ≥ 2), and 64.4% reported more severe daily symptoms by the EXACT-PRO. Most patients (71.6%) reported high scores on ≥ 2 PROs. More patients with high symptom burden had COPD-related emergency department visits than those with lower disease burden (27.6% vs 12.7%, P = 0.012). Conclusions In conclusion, a large proportion of patients with COPD receiving LAMA monotherapy experienced a high symptom burden and may benefit from therapy escalation. Healthcare professionals can use validated PROs to help them assess symptom burden. Funding GlaxoSmithKline (GSK study number: 205862) Electronic supplementary material The online version of this article (10.1007/s41030-019-0091-0) contains supplementary material, which is available to authorized users.

Purpose Current understanding of the relationship between COPD phenotype and health care resource utilization (HCRU) is limited. This real-world study evaluated disease burden and HCRU for COPD subgroups prone to exacerbation as defined by blood eosinophil (EOS) count and multiple inhaler triple therapy (MITT) use. Methods This was a large-scale, retrospective, longitudinal, observational cohort study using data from the US IBM Watson Explorys real-world database (GSK Study HO-17-18395). The population of interest comprised patients with COPD ≥40 years of age with ≥2 moderate or ≥1 severe exacerbations (prior year) while on inhaled maintenance therapy, with ≥1 blood EOS count. Data were analyzed during the year prior to index date (last COPD encounter between January 1, 2011 and December 31, 2016). Four subgroups were analyzed based on a combination of EOS counts (

Jean-Pierre Llanos,1 Christopher F Bell,1 Elizabeth Packnett,2 Ellen Thiel,2 Debra E Irwin,2 Beth Hahn,1 Hector Ortega3 1Respiratory, US Medical Affairs, GSK, Research Triangle Park, NC, USA; 2Truven Health Analytics, An IBM Watson Health Company, Ann Arbor, MI, USA; 3Respiratory, US Medical Affairs, GSK, La Jolla, CA, USA Purpose: Patients with severe asthma are eligible for asthma-specific biologics as add-on therapies, such as mepolizumab and omalizumab, when optimized controller therapies are unable to control their symptoms. However, few real-world data are available to describe the characteristics and associated economic burden of patients considered to be candidates for mepolizumab or omalizumab therapy.Methods: This retrospective cohort study investigated patients with asthma (≥12 years of age) identified at the time of first mepolizumab or omalizumab administration (index date) in the MarketScan™ Commercial Database. Data were collected during the 12-month period before the index date (baseline period) for two mutually exclusive patient groups (patients prescribed mepolizumab and omalizumab, respectively). Baseline demographics, history of exacerbations, healthcare resource utilization (HCRU), and medical costs were investigated.Results: In total, 413 and 1,834 patients who had been prescribed mepolizumab or omalizumab, respectively, were identified. During the baseline period, patients prescribed mepolizumab experienced more exacerbations (81.4%vs 57.5%, P

BACKGROUND Patients with severe asthma frequently have associated comorbidities, which can compound existing symptoms, complicating asthma management. OBJECTIVE To describe the real-world effectiveness of mepolizumab in patients with severe asthma stratified by common overlapping comorbidities. METHODS This was a retrospective analysis of patients with asthma from the MarketScan Commercial and Medicare Supplemental Database initiating mepolizumab treatment (index date). Eligible patients had more than or equal to 1 claim (excluding claims for diagnostic tests) with a diagnosis code for more than or equal to 1 of 7 comorbidities (atopic disease, nasal polyps, chronic sinusitis, obesity, respiratory infections, chronic obstructive pulmonary disease, and depression/anxiety) during the 12-month preindex baseline period; these were used to stratify patients into 7 nonmutually exclusive subgroups. Outcomes included asthma exacerbations and exacerbation-related health care resource utilization during the 12-month baseline and follow-up periods. Each patient acted as their own control. RESULTS Of the 639 patients included, the most common comorbidities were atopic diseases (73.2%), respiratory infections (55.6%), and chronic sinusitis (45.1%). Across all 7 comorbidity subgroups, there were significant (P < .05) reductions of 38% to 55% and 57% to 83% in exacerbations and exacerbations requiring hospitalization, respectively, during the follow-up vs baseline period, except for exacerbations requiring hospitalization in the nasal polyp subgroup, owing to the small subgroup sample size. During the follow-up vs baseline periods, mean number of oral corticosteroids claims was significantly (P < .001) reduced by 29% to 38%; 39% to 47% of patients achieved greater than or equal to 50% oral corticosteroids dose reduction. Significant reductions in exacerbation-related health care resource utilization were also observed. CONCLUSION Mepolizumab treatment provided real-world clinical benefits in patients.

Introduction Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbations are at risk of further readmissions, increased treatment costs, and excess mortality. This study evaluated inpatient admissions and readmissions in patients receiving initial maintenance therapy with umeclidinium/vilanterol (UMEC/VI) versus tiotropium (TIO). Methods This retrospective, matched cohort study identified patients with COPD who initiated maintenance therapy with UMEC/VI or TIO from Optum’s de-identified Clinformatics Data Mart database between January 1, 2013, and December 31, 2018 (index date defined as earliest dispensing). Eligibility criteria included: ≥ 1 medical claim for COPD pre-index or on the index date; ≥ 12 months of continuous eligibility pre-index; age ≥ 40 years at index; no pre- or post-index asthma diagnosis; and no pre-index claims for medications containing inhaled corticosteroids, long-acting β2-agonists, or long-acting muscarinic antagonists. Outcomes included time to first on-treatment COPD-related inpatient admission, rate of on-treatment COPD-related admissions, and rate of all-cause and COPD-related readmissions within 30 and 90 days. Propensity score matching was used to adjust for potential confounders. Results Matched UMEC/VI and TIO cohorts each included 7997 patients and were balanced on baseline characteristics (mean age 70.9 years; female 47.1–47.6%). Over 12 months, patients initiating UMEC/VI had significantly reduced risk (hazard ratio [95% CI]: 0.87 [0.79, 0.96]; p = 0.006) and rates (rate ratio [95% CI]: 0.80 [0.72, 0.92]; p = 0.008) of COPD-related inpatient admissions compared with TIO. While all-cause readmission rates were similar between treatment cohorts, readmission rates among patients with an initial admission length of stay of 1–3 days were numerically lower for UMEC/VI versus TIO (30-day readmissions: 10.5% vs. 12.4%; 90-day readmissions: 15.5% vs. 19.8%). Similar patterns were observed for COPD-related readmissions. Conclusions These findings highlight the real-world benefits of dual therapy with UMEC/VI versus TIO in reducing inpatient admissions and readmissions in patients with COPD, which may translate to lower healthcare costs. Supplementary Information The online version contains supplementary material available at 10.1007/s41030-021-00151-y., Plain Language Summary Patients with chronic obstructive pulmonary disease (COPD) who are admitted to the hospital are more likely to be readmitted in the future, have higher healthcare costs, and are more likely to die from their illness. Patients who are readmitted to hospital have even higher treatment costs. Identifying which treatments are best at reducing the number of patients with COPD who are admitted to the hospital may help to improve outcomes and reduce the cost of COPD treatment. We used US healthcare claims data to compare two daily treatments for COPD, umeclidinium/vilanterol and tiotropium. We aimed to find out which treatment was more effective at reducing hospital admissions due to COPD. We also compared how many patients on each treatment were readmitted within 30 or 90 days of their original hospital admission for COPD. We found that patients who started treatment with umeclidinium/vilanterol were less likely to be admitted to the hospital for COPD than patients who started treatment with tiotropium. Similar numbers of patients on each treatment were readmitted to the hospital within 30 or 90 days after they were discharged. However, among patients whose initial hospital stay was short (1–3 days), readmissions within 30 or 90 days were less common with umeclidinium/vilanterol than tiotropium. These findings suggest that umeclidinium/vilanterol may be more effective than tiotropium at reducing the number of patients with COPD who need to be admitted or readmitted to hospital. Starting COPD treatment with umeclidinium/vilanterol may lead to better health outcomes and lower costs than tiotropium. Supplementary Information The online version contains supplementary material available at 10.1007/s41030-021-00151-y.

Background Adherence to chronic obstructive pulmonary disease (COPD) maintenance medication is important for managing symptoms and exacerbation risk, and is associated with reduced mortality, hospitalizations, and costs. This study compared on-treatment exacerbations, medical costs, and medication adherence in patients with COPD initiating treatment with umeclidinium/vilanterol (UMEC/VI) or tiotropium (TIO). Methods This retrospective matched cohort study selected patients from Optum’s de-identified Clinformatics Data Mart database who initiated maintenance treatment with UMEC/VI or TIO between 01/01/2014 and 12/31/2017 (index date defined as the first dispensing). Eligible patients were ≥ 40 years of age and had ≥ 12 months continuous health plan coverage pre- and post-index; ≥ 1 medical claim for COPD pre-index or on the index date; no moderate/severe COPD-related exacerbations on the index date; no asthma diagnosis pre- or post-index; no maintenance medication fills containing inhaled corticosteroids, long-acting β2-agonists, or long-acting muscarinic antagonists pre-index or on the index date; and no fills for both UMEC/VI and TIO on the index date. Outcomes included time-to-first (Kaplan–Meier analysis) and rates of on-treatment COPD-related moderate/severe exacerbations, medication adherence (proportion of days covered [PDC] and proportion of adherent patients [PDC ≥ 0.8]), and COPD-related medical costs per patient per month (PPPM). Propensity score matching was used to adjust for potential confounders. Results Each cohort included 3929 matched patients. Kaplan–Meier rates of on-treatment COPD-related exacerbations were similar between cohorts (hazard ratio at 12 months; overall: 0.93, moderate: 0.92, severe: 1.07; all p > 0.05). UMEC/VI versus TIO initiators had significantly higher adherence (mean PDC: 0.44 vs 0.37; p pp = 0.028), driven by lower outpatient visit costs. Conclusions These findings provide valuable information for physicians considering UMEC/VI or TIO as initial maintenance therapy options for patients with COPD.

Hector Ortega,1 Jean-Pierre Llanos,2 Marie-Hélène Lafeuille,3 Guillaume Germain,3 Mei Sheng Duh,4 Christopher F Bell,2 Susan R Sama,5 Beth Hahn2 1Respiratory, US Medical Affairs, GSK, La Jolla, CA, USA; 2Respiratory, US Medical Affairs, GSK Research Triangle Park, NC, USA; 3Groupe d’analyse, Ltée, Montréal, QC, Canada; 4Analysis Group, Inc., Boston,MA, USA; 5Research Department, Reliant Medical Group, Worcester,MA, USA Purpose: Based on blood and sputum samples, up to 40% of patients with COPD have eosinophilic inflammation; however, there is little epidemiology data characterizing the health care burden within this sub-population. Given that COPD-attributable medical costs in the USA are predicted to approach $50 billion by 2020, we analyzed the effect of blood eosinophil counts and exacerbations on health care resource utilization and costs. Patients and methods: This cross-sectional study used electronic medical records and insurance claims data from the Reliant Medical Group (January 2011–December 2015). Eligible patients were ≥40 years of age, continuously enrolled during the year of interest (2012, 2013, 2014, or 2015), had ≥1 COPD-related code in the preceding year, and documented maintenance therapy use. Patients with ≥1 blood eosinophil count recorded were stratified into 2 cohorts

Chad Moretz,1 Lucie Sharpsten,2 Lindsay GS Bengtson,2 Eleena Koep,2 Lisa Le,2 Junliang Tong,2 Richard H Stanford,1 Beth Hahn,1 Riju Ray31US Value Evidence and Outcomes, GSK, Durham, NC, USA; 2Health Economics and Outcomes Research, Optum, Eden Prairie, MN, USA; 3US Medical Affairs, GSK, Durham, NC, USABackground and objective: Retrospective claims data in patients with chronic obstructive pulmonary disease (COPD) initiating maintenance therapy with inhaled fixed-dose combinations of long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) versus inhaled corticosteroid (ICS)/LABA have not been reported.Methods: Retrospective observational study in a COPD-diagnosed population of commercial and Medicare Advantage with Part D (MAPD) enrollees aged ≥40 years from a US health insurer database. Patients initiated umeclidinium/vilanterol (UMEC/VI [62.5/25 μg]) or fluticasone propionate/salmeterol (FP/SAL [250/50 μg]) between April 1, 2014 and August 31, 2016 (index date) and had 12 months continuous enrollment pre- and post-index. Exclusion criteria included an asthma diagnosis in the pre-index period/index date; ICS-, LABA-, or LAMA-containing therapy during the pre-index period; or pharmacy fills for both UMEC/VI and FP/SAL, multiple-inhaler triple therapy, a non-index therapy, or COPD exacerbation on the index date. Adherence (proportion of days covered [PDC] ≥80%) was modeled using weighted logistic regression following inverse probability of treatment weighting (IPTW). Weighted Kaplan–Meier and Cox proportional hazards regression following IPTW were performed for incidence of COPD exacerbation and escalation to multiple-inhaler triple therapy.Results: The study population included 5306 patients (1386 initiating UMEC/VI and 3920 initiating FP/SAL). Adjusted odds of adherence were 2.00 times greater among UMEC/VI than FP/SAL initiators (95% confidence interval [CI]: 1.62─2.46; P

Background Approximately 30% to 50% of patients with moderate/severe asthma have inadequately controlled disease despite adherence to inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy. Data on prevalence and burden of uncontrolled asthma in specialty settings are lacking. Objective To evaluate the prevalence and burden of uncontrolled asthma in respiratory specialist clinics in the United States. Methods Adults with physician-diagnosed asthma attending pulmonary and allergy clinics with self-reported ICS use in the previous 4 weeks completed an electronic questionnaire including the Asthma Control Test and St George’s Respiratory Questionnaire. Additional information was collected using an electronic case report form. Results Of 774 patients attending 12 pulmonary and 12 allergy clinics, 53% were not well controlled (mean [SD] Asthma Control Test, 14.3 [3.6] vs 22.4 [1.6] in well-controlled patients). Among ICS/LABA users, 56% were not well controlled, which increased with increasing ICS dose (low-dose 45.7%; high-dose 59.7%). The not well-controlled group reported more respiratory illnesses, more comorbidities, and poorer health-related quality of life (mean [SD] St George’s Respiratory Questionnaire, 46.1 [18.9] vs 19.8 [12.9] in the well-controlled group). These patients also had more asthma exacerbations (≥1 exacerbation, 68.9% vs 43.1%) and increased health care resource utilization (≥1 asthma-related hospitalization, 10.7% vs 2.7%); 27.3% were also receiving systemic corticosteroids. Approximately 40% of the population were eligible for step-up to ICS/LABA/long-acting muscarinic antagonist triple therapy, and 20% were eligible for biologic therapy. Conclusion Substantial unmet needs exist among patients with inadequately controlled asthma managed in United States specialist settings, which may be addressed by improved patient and physician education, better guideline implementation, and improved adherence.

Background Chronic obstructive pulmonary disease (COPD) is associated with high clinical and economic burden. Optimal pharmacological therapy for COPD aims to reduce symptoms and the frequency and severity of exacerbations. Umeclidinium/vilanterol (UMEC/VI) is an approved combination therapy for once-daily maintenance treatment of patients with COPD. This study evaluated the impact of delaying UMEC/VI initiation on medical costs and exacerbation risk. Methods A retrospective analysis of patients with COPD who initiated UMEC/VI between 4/28/2014 and 7/31/2016 was conducted using the Optum Research Database. The index date was the first COPD visit after UMEC/VI available on US formulary (Commercial 4/28/2014; Medicare Advantage 1/1/2015). Patients were followed for 12 months post-index, and categorized into 12 cohorts corresponding to month (30-day period) of UMEC/VI initiation (i.e. Months 1–12) post-index. The outcomes studied during the follow up period included COPD-related and all-cause medical costs, and risk of COPD exacerbations. Marginal structural models (MSM) were used to control for time-varying confounding due to changes in treatment and severity during follow up. Results 2,200 patients initiating UMEC/VI were included in the study sample. Patients’ average age was 69.3 years, 49.9% were female and 69.7% were Medicare insured. Following MSM analysis, 12-month adjusted COPD-related medical costs increased by 2.9% (95% confidence interval [CI]: 0.1–5.9%; p = 0.044) for each monthly delay in UMEC/VI initiation, with a 37.4% higher adjusted cost for patients initiating UMEC/VI in Month 12 versus Month 1 ($13,087 vs. $9524). The 12-month adjusted all-cause medical costs increased by 2.8% (95% CI: 0.6–5.2%; p = 0.013) for each monthly delay, with a 36.1% higher adjusted cost for patients initiating UMEC/VI at Month 12 versus Month 1 ($22,766 vs. $16,727). The monthly risk of severe exacerbation was significantly higher in patients who had not yet initiated UMEC/VI than those who had (hazard ratio: 1.74; 95% CI: 1.35–2.23; p

Jean-Pierre Llanos,1 Hector Ortega,2 Guillaume Germain,3 Mei Sheng Duh,4 Marie-Helene Lafeuille,3 Sean Tiggelaar,3 Christopher F Bell1, Beth Hahn1 1US Medical Affairs, GSK, Research Triangle Park, NC, USA; 2US Medical Affairs, GSK, La Jolla, CA, USA; 3Groupe d’Analyse, Ltée, Montréal, QC, Canada; 4Analysis Group, Inc., Boston, MA, USA Introduction: Asthma and COPD have overlapping characteristics. As there are limited data on whether asthma–COPD overlap (ACO) represents a distinct condition, this study aimed to determine the similarities and differences of ACO with asthma and COPD.Methods: US population-based, cross-sectional study using National Health and Nutrition Examination Survey data (2009–2012) compared participants with ACO vs those with asthma or COPD, each as mutually exclusive disease states. Demographics, health status, disability/limitations, health care resource utilization, clinical characteristics, and peripheral blood eosinophil counts were analyzed.Results: A total of 1,609, 479, and 299 participants with asthma, COPD, and ACO, respectively, were included. An age-matched asthma subgroup included 299 participants from the asthma group. Compared with asthma and COPD, participants with ACO had worse health status, increased disease burden, and more comorbid conditions. The ACO, vs age-matched asthma subgroup, had lower percent predicted prebronchodilator forced expiratory volume in 1 second (82.1% vs 88.0%; P=0.017). The ACO group had significantly more asthma attacks in the past year than the age-matched asthma subgroup (49.8% vs 38.4%; P

Objectives Data on symptom burden or medication adherence in patients with chronic obstructive pulmonary disease (COPD) within a community pharmacy setting are limited. This study assessed symptom burden and adherence to respiratory medications in individuals reporting COPD, chronic bronchitis, or emphysema diagnoses visiting community pharmacies. Design This cross-sectional study enrolled participants visiting 35 community pharmacies in Missouri (October 2016 to April 2017). Participants Eligible participants (aged 40 years or more with a self-reported history of COPD, prescription for at least 1 COPD maintenance medication during the previous 12 months, and able to complete an English questionnaire) were identified from pharmacy dispensing records. Main outcome measures Participants completed a questionnaire assessing demographics, clinical characteristics, health literacy, COPD Assessment Test (CAT) modified Medical Research Council (mMRC) dyspnea scale scores, and exacerbation history. Recent spirometry data were obtained, if available, from participants’ physicians. COPD was classified according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2016 criteria. Medication adherence was assessed as proportion of days covered (PDC) from dispensing records. Results Of 682 participants (mean age 63.0 years; 57% female) with available pharmacy data, 251 (36.8%) had available spirometry data. Most participants had mMRC scores ≥ 2 (60.9%) and CAT scores ≥ 10 (90.2%); 57.2% reported at least 2 moderate or 1 or more severe exacerbations within the previous 12 months. GOLD classifications varied depending on the scale used (mMRC vs. CAT); more participants were classified as group C/D than group A/B, with the highest proportion classified as group D (higher symptom burden and exacerbation risk). Mean PDC was 0.46 ± 0.37; only 28.7% of participants were adherent (PDC ≥ 80%) to at least 1 COPD maintenance medication. Conclusion Individuals self-reporting a COPD diagnosis receiving respiratory medications from community pharmacies in Missouri have a high symptom burden and low medication adherence. Further research should determine reasons for low adherence and ways to reduce COPD symptoms.

Introduction: Systemic corticosteroids (SCS) are effective anti-inflammatory therapies for patients with severe or persistent asthma. Use of SCS reduces blood eosinophil counts; the magnitu...

Dual bronchodilator maintenance therapy may benefit patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) versus long-acting muscarinic antagonist (LAMA) monotherapy. The efficacy and safety of US-approved LAMA/long-acting beta-agonist (LABA) combinations versus tiotropium (TIO), a LAMA, were assessed. This systematic review and meta-analysis (GSK: 206938), conducted in MEDLINE, MEDLINE In-process, and EMBASE following Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines, identified randomized clinical trials (>8 weeks) in moderate-to-severe COPD (per Global Initiative for Chronic Obstructive Lung Disease guidelines), receiving LAMA/LABA or TIO. Endpoints: difference in change from baseline in lung function (forced expiratory volume in 1 s [FEV1]; trough, peak, area under the curve 0–3 h post-dose (AUC0–3), St George’s Respiratory Questionnaire (SGRQ) responder rate (≥4-unit improvement), SGRQ total score, and rescue medication use at 12 and 24 weeks. Safety was also assessed. From 5683 citations, the meta-analysis included eight clinical trials. LAMA/LABA significantly improved FEV1 trough (Week 12: 63.0 mL, 95% confidence intervals [CI]: 39.2, 86.8; Week 24: 66.1 mL, 95% CI: 40.0, 92.3), peak (Week 12: 91.5 mL, 95% CI: 70.5, 112.4; Week 24: 92.4 mL, 95% CI: 72.9, 111.9), AUC0–3 (Week 12: 126.8 mL, 95% CI: 108.1, 145.4), SGRQ responder rate at Week 12 (risk ratio: 1.19; 95% CI: 1.09, 1.28), mean SGRQ total score (Week 12: −1.87, 95% CI: −2.72, −1.02; Week 24: −1.05, 95% CI: −2.02, −0.09), and rescue medication use (Week 24: −0.47 puffs/day, 95% CI: −0.64, −0.30) versus TIO (all p ≤ 0.03). The SGRQ responder rate at 24 weeks and adverse events were not significantly different between treatments. US-approved LAMA/LABA therapies improved lung function, SGR,Q and rescue medication use versus TIO, without compromising safety., Chronic lung disease: Examining dual therapy efficacy Dual maintenance therapies combining two types of long-acting bronchodilator appear to be effective and safe for treating moderate-to-severe chronic obstructive pulmonary disease (COPD). Given that patients with COPD often have poor quality of life and, in the US, incur substantial healthcare costs, it is vital to provide optimal symptom management to improve lung function and limit exacerbations over time. Beth Hahn at GSK, North Carolina, and co-workers carried out a literature review and meta-analysis of 8 clinical trials, which indicates that combined long-acting muscarinic antagonist (LAMA)/long-acting beta-agonist (LABA) treatments—currently prescribed in the US—are an effective and safe way of tackling COPD symptoms. The team compared patients using LAMA/LABA for 12 weeks with those on single LAMA (tiotropium) treatment and found LAMA/LABA significantly improved lung function and reduced exacerbation risk.

Background: Eradication of Helicobacter pylori has been shown to prevent relapse of endoscopically detected duodenal ulcers. There is controversy regarding symptom improvement after therapy. Some studies have suggested that a substantial number of patients remain symptomatic after eradication therapy. Other studies suggest that gastro-oesophageal reflux disease (GERD) may develop as a result of H. pylori eradication. Aim: To determine the relationship between symptoms and H. pylori eradication and to determine whether H. pylori eradication results in symptoms or endoscopic findings of GERD. Methods: Two hundred and forty-two patients with endoscopically documented duodenal ulcer disease and evidence of H. pylori infection by rapid urease testing and histology were studied in four randomized, placebo-controlled, double-blind trials of H. pylori eradication therapy. All patients underwent symptom assessment and endoscopy with biopsy before therapy and 1 and 6 months after completing therapy. The rapid urease test and histology were used to determine H. pylori status. Interviewers were blinded to H. pylori status after eradication and were unaware of the endoscopic findings (interviews were performed prior to repeat endoscopy). Results: The presence of epigastric pain was significantly associated with persistent H. pylori infection 1 month after therapy (odds ratio 2.3, 95% CI: 1.02–5.2; P=0.041), as was nausea (OR 7.1, 95% CI: 0.93–55.6; P=0.029). The presence of epigastric pain was significantly associated with ulcer relapse at 6 months (OR 7.5, 95% CI: 3.6–15.7; P

Background and Purpose— In controlled trials, anticoagulation with warfarin reduces stroke risk by nearly two thirds, but the benefit has been less pronounced in clinical practice. This report describes the extent of warfarin use, its effectiveness, and its impact on medical costs among Medicare patients with nonvalvular atrial fibrillation. Methods— Using claims from >2 million beneficiaries in the Centers for Medicare and Medicaid Services 5% Sample Standard Analytic Files, we identified patients with nonvalvular atrial fibrillation from 2004 to 2005. Warfarin use was inferred from 3 or more tests of the international normalized ratio within 1 year. Incidence of ischemic/hemorrhagic stroke and major bleeding was evaluated. Adjusted risk was calculated by Cox proportional-hazards regression. Medical costs (reimbursed amounts in 2006 US dollars) were estimated by multivariate linear regression. Results— Of patients with nonvalvular atrial fibrillation (N=119 764, mean age=79.3 years), 58.5% were categorized as warfarin users based on the study definition. During an average of 2.1 years' follow-up, the rate of ischemic stroke was 3.9 per 100 patient-years. After multivariate adjustment, ischemic stroke incidence was 27% lower in patients taking warfarin than in patients not taking warfarin ( P Conclusions— These results indicate that 41.5% of Medicare patients with nonvalvular atrial fibrillation are not anticoagulated with warfarin. The incidence of stroke and overall medical costs were significantly lower in patients treated with warfarin.

The aim of this study was to assess the impact of alosetron, a treatment recently approved in the United States for irritable bowel syndrome in diarrhea-predominant female patients, on health-related quality of life.Quality of life was assessed as part of two 12-wk randomized, double-blind, placebo-controlled irritable bowel syndrome studies comparing alosetron 1 mg b.i.d. with placebo (S3BA3001 and S3BA3002). Patients completed a validated disease-specific quality of life questionnaire, the Irritable Bowel Syndrome Quality of Life Questionnaire (IBSQOL), at baseline and at the 12-wk or final visit. The clinical relevance of data were also evaluated by a minimal meaningful difference instrument.A total of 626 and 647 patients were enrolled in studies S3BA3001 and S3BA3002, respectively. Approximately 70% of patients in each study had diarrhea-predominant IBS. In diarrhea-predominant patients enrolled in S3BA3001, statistically significant (p0.05) improvements with alosetron versus placebo were observed on all nine IBSQOL scales (emotional health, mental health, sleep, energy, physical functioning, food/diet, social functioning, role-physical, and sexual relations) and for all but one scale (mental health) in S3BA3002. In both studies, a significantly greater percentage of patients treated with alosetron (p0.05) experienced clinically meaningful improvement on three of the nine IBSQOL scales (food/diet, social functioning, and role-physical) compared with patients treated with placebo. Patients treated with alosetron did not show worsening in any quality of life domain compared with patients treated with placebo.These results in women with diarrhea-predominant IBS demonstrate that alosetron significantly improves health-related quality of life.

Background: Although irritable bowel syndrome (IBS) is not a life-threatening condition, it can have a serious impact on a patient’s daily activities and quality of life. This effect on quality of life has not been compared previously across different cultures. Methods: We compared measures of health-related quality of life and health care resource utilization using a cross-sectional point-in-time postal survey of a random sample of 500 members of the International Foundation for Functional Gastrointestinal Disorders in the US and 500 members of the IBS Network support group in the UK. The analysis was limited to persons who reported that a physician had told them they had IBS. A general health status questionnaire, the SF-36, and a disease-specific questionnaire, the Irritable Bowel Syndrome Quality of Life questionnaire (IBSQOL), were self-administered as part of the survey to measure health-related quality of life. Results on the SF-36 were compared with published normative data for adults in the US and UK with and without chronic diseases. Results: The UK group (n = 343) reported significantly poorer quality of life on the SF-36 and on four parameters of the IBSQOL than did the US group (n = 287). The general health status of persons with IBS in either country was much poorer compared with that of general populations in the respective countries. Health care resource utilization (i.e. emergency room, doctor and hospital outpatient visits) of persons with IBS was similar in the two countries, as was the direct effect of IBS on employment. Nearly one third of those surveyed missed at least 1 day of work due to IBS in the previous 4 weeks, and a greater percentage cut back in their work or activites due to IBS. Taken together, average time lost or cut back amounted to nearly 5 days or 1 work-week. Conclusion: IBS has a significant impact on quality of life and resource use in both the US and UK. The effect on quality of life, however, appears to be greater in the UK than in the US.