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Jonathan Grigg,1 Anjan Nibber,2 James Y Paton,3 Alison Chisholm,2 Theresa W Guilbert,4 Alan Kaplan,5 Steve Turner,6 Nicolas Roche,7 Elizabeth V Hillyer,8 David B Price8,9 On behalf of the Respiratory Effectiveness Group 1Blizard Institute, Queen Mary University of London, London, UK; 2Respiratory Effectiveness Group, Cambridge, UK; 3School of Medicine, College of Medical, Veterinary, and Life Sciences, University of Glasgow, Glasgow, UK; 4Pulmonary Division, Cincinnati Children’s Hospital Medical Center, and Department of Pediatrics, University of Cincinnati, Cincinnati, OH, USA; 5Family Physician Airways Group of Canada, University of Toronto, Toronto, ON, Canada; 6Department of Child Health, Royal Aberdeen Children’s Hospital, University of Aberdeen, Aberdeen, UK; 7Respiratory Medicine, Cochin Hospital Group, AP-HP, University of Paris Descartes (EA2511), Paris, France; 8Observational and Pragmatic Research Institute Pte Ltd, Singapore, Singapore; 9Academic Primary Care, University of Aberdeen, Aberdeen, UK Background: An inhaled corticosteroid (ICS) or leukotriene receptor antagonist (LTRA) may prevent wheezing/asthma attacks in preschoolers with recurrent wheeze when added to short-acting β-agonist (SABA).Objective: The aim of this historical matched cohort study was to assess the effectiveness of these treatments for preventing wheezing/asthma attacks.Methods: Electronic medical records from the Optimum Patient Care Research Database were used to characterize a UK preschool population (1–5 years old) with two or more episodes of wheezing during 1 baseline year before first prescription (index date) of ICS or LTRA, or repeat prescription of SABA. Children initiating ICS or LTRA on the index date were matched 1:4 to those prescribed only SABA for age, sex, year of index prescription, mean baseline SABA dose, baseline attacks, baseline antibiotic prescriptions, and eczema diagnosis. Wheezing/asthma attacks (defined as asthma

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Anne Burden,1 Nicolas Roche,2 Cristiana Miglio,1 Elizabeth V Hillyer,1 Dirkje S Postma,3 Ron MC Herings,4 Jetty A Overbeek,4 Javaria Mona Khalid,5 Daniela van Eickels,6 David B Price1,7 1Observational and Pragmatic Research Institute Pte Ltd, Singapore; 2University Paris Descartes (EA2511), Cochin Hospital Group (AP-HP), Paris, France; 3Department of Pulmonology, University Medical Center Groningen, University of Groningen, Groningen, 4PHARMO Institute for Drug Outcomes Research, Utrech, the Netherlands; 5Takeda Development Centre Europe Ltd, London, UK; 6Takeda Pharmaceuticals International GmbH, Zurich, Switzerland; 7Academic Primary Care, University of Aberdeen, Aberdeen, UK Background: Cohort matching and regression modeling are used in observational studies to control for confounding factors when estimating treatment effects. Our objective was to evaluate exact matching and propensity score methods by applying them in a 1-year pre–post historical database study to investigate asthma-related outcomes by treatment. Methods: We drew on longitudinal medical record data in the PHARMO database for asthma patients prescribed the treatments to be compared (ciclesonide and fine-particle inhaled corticosteroid [ICS]). Propensity score methods that we evaluated were propensity score matching (PSM) using two different algorithms, the inverse probability of treatment weighting (IPTW), covariate adjustment using the propensity score, and propensity score stratification. We defined balance, using standardized differences, as differences of <10% between cohorts. Results: Of 4064 eligible patients, 1382 (34%) were prescribed ciclesonide and 2682 (66%) fine-particle ICS. The IPTW and propensity score-based methods retained more patients (96%–100%) than exact matching (90%); exact matching selected less severe patients. Standardized differences were >10% for four variables in the exact-matched dataset and <10% for both PSM algorithms and t

Dirkje S Postma,1 Nicolas Roche,2 Gene Colice,3 Elliot Israel,4 Richard J Martin,5 Willem MC van Aalderen,6 Jonathan Grigg,7 Anne Burden,8 Elizabeth V Hillyer,8 Julie von Ziegenweidt,8 Gokul Gopalan,9 David Price8,10 1University of Groningen, Department of Pulmonary Medicine and Tuberculosis, University Medical Center Groningen, Groningen, the Netherlands; 2Respiratory and Intensive Care Medicine, Cochin Hospital Group, APHP, Paris-Descartes University (EA2511), Paris, France; 3Pulmonary, Critical Care and Respiratory Services, Washington Hospital Center and George Washington University School of Medicine, Washington DC, USA; 4Pulmonary and Critical Care Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; 5Department of Medicine, National Jewish Health, Denver, CO, USA; 6Dept of Pediatric Respiratory Medicine and Allergy, Emma Children's Hospital AMC, Amsterdam, the Netherlands; 7Blizard Institute, Queen Mary University London, London, UK; 8Research in Real Life, Ltd, Cambridge, UK; 9Respiratory, Global Scientific Affairs, Teva Pharmaceuticals, Frazer, PA, USA; 10Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK Purpose: Small airway changes and dysfunction contribute importantly to airway obstruction in chronic obstructive pulmonary disease (COPD), which is currently treated with inhaled corticosteroids (ICS) and long-acting bronchodilators at Global initiative for Obstructive Lung Disease (GOLD) grades 2–4. This retrospective matched cohort analysis compared effectiveness of a representative small-particle ICS (extrafine beclomethasone) and larger-particle ICS (fluticasone) in primary care patients with COPD. Patients and methods: Smokers and ex-smokers with COPD ≥40 years old initiating or stepping-up their dose of extrafine beclomethasone or fluticasone were matched 1:1 for demographic characteristics, index prescription year, concomitant therapies, and d

David Price1,2 John Haughney1, Erika Sims2, Muzammil Ali2, Julie von Ziegenweidt2, Elizabeth V Hillyer2, Amanda J Lee3, Alison Chisholm2, Neil Barnes41Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK; 2Research in Real Life Ltd, Cawston, Norwich, UK; 3Section of Population Health, University of Aberdeen, UK; 4Department of Respiratory Medicine, London Chest Hospital, Barts and The London NHS Trust, London, UKPurpose: Results of randomized controlled trials may not predict effectiveness of inhaled corticosteroids (ICS) in real-world clinical practice, where inhaler technique and device characteristics can influence effectiveness. We compared asthma outcomes for ICS delivered via three different inhaler devices: pressurized metered-dose inhaler (pMDI), breath-actuated MDI (BAI), and dry powder inhaler (DPI).Patients and methods: This retrospective database study evaluated 1-year outcomes for primary care patients with asthma aged 5–60 years prescribed their first ICS (initiation population) by pMDI (n = 39,746), BAI (n = 9809), or DPI (n = 6792), or their first ICS dose increase (step-up population) by pMDI (n = 6245), BAI (n = 1388), or DPI (n = 1536). Co-primary outcome measures were composite proxy measures of asthma control (no hospital attendance for asthma, oral corticosteroids, or antibiotics for lower respiratory infection) and severe exacerbations (unscheduled hospital admission, emergency room attendance, or oral corticosteroids). Outcomes were adjusted for potential confounding factors identified during a baseline year.Results: In the initiation population, adjusted odds ratios (95% confidence intervals [CI]) for asthma control, as compared with pMDIs, were significantly better for BAIs (1.08 [1.02–1.14]) and DPIs (1.13 [1.06–1.21]), while adjusted exacerbation rate ratios (95% CI) were 1.00 (0.93–1.08) and 0.88 (0.81–0.95), respectively. In the step-up population, adjusted odds of asthm

Linda Kemp1, John Haughney2, Neil Barnes3, Erika Sims1, Julie von Ziegenweidt1, Elizabeth V Hillyer1, Amanda J Lee4, Alison Chisholm1, David Price1,21Research in Real Life Ltd, Old Winery Business Park, Cawston, Norwich, UK; 2Centre of Academic Primary Care, University of Aberdeen, Foresterhill Health Centre, Westburn Road, Aberdeen, UK; 3Department of Respiratory Medicine, London Chest Hospital, Bonner Road, London, UK; 4Medical Statistics Team, Section of Population Health, University of Aberdeen, Foresterhill, Aberdeen, UKPurpose: To evaluate and compare real world cost-effectiveness of inhaled corticosteroids (ICS) administered by metered dose inhaler (MDI), breath-actuated MDI (BAI), or dry powder inhaler (DPI) in asthma.Patients and methods: This retrospective database study analyzed the direct health care costs and proportion of patients (aged 5–60 years) achieving asthma control over 1 year in two population groups: those starting ICS (initiation population) and those receiving a first increase in ICS dose (step-up population). Asthma control was defined as no unplanned asthma visits, oral corticosteroids, or antibiotics for lower respiratory infection; outcomes were adjusted for confounding variables. Cost-effectiveness of BAI and DPI were compared with MDI.Results: For the initiation population (n = 56,347), average annual health care costs per person (adjusted results), as compared with MDIs, were £9 higher (95% CI: -1.65 to 19.71) for BAIs and £32 higher (95% CI: 19.51 to 43.66) for DPIs. The probability of BAIs being the dominant strategy (more effective and less costly than MDIs) was 5% and of BAIs being more effective and more costly than MDIs was 94%. DPIs were consistently more effective and more costly than MDIs, with an incremental cost-effectiveness ratio of £1711 (95% CI: 760 to 3,576) per additional controlled patient per year. For the step-up population (n = 9169), mean total health care costs per person