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Kai-Michael Beeh,1 Kieran J Rothnie,2 Jing Claussen,3 Fränce Hardtstock,4 Rachel K Knapp,4 Thomas Wilke,5 Alexandrosz Czira,2 Chris Compton,6 Afisi S Ismaila7,8 1Insaf Respiratory Research Institute, Wiesbaden, Germany; 2Value Evidence and Outcomes, R&D Global Medical, GSK, Brentford, UK; 3Global Medical Affairs, GSK, Munich, Germany; 4Real World & Advanced Analytics (RWAA), Cytel, Berlin, Germany; 5IPAM e.V., Institute affiliated with University of Wismar, Wismar, Germany; 6Global Medical, GSK, London, UK; 7Value Evidence and Outcomes, R&D Global Medical, GSK, Collegeville, PA, USA; 8Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S Ismaila, Value Evidence and Outcomes, GSK, 1250 South Collegeville Road, Collegeville, PA, 19426-0989, USA, Tel +1 919 315 8229, Email afisi.s.ismaila@gsk.comPurpose: To assess patient characteristics of users and new initiators of triple therapy for chronic obstructive pulmonary disease (COPD) in Germany.Patients and Methods: Retrospective cohort study of patients with COPD and ≥ 1 prescription for single-inhaler triple therapy (SITT; fluticasone furoate/umeclidinium/vilanterol [FF/UMEC/VI] or beclomethasone dipropionate/glycopyrronium bromide/formoterol [BDP/GLY/FOR]) or multiple-inhaler triple therapy (MITT), using data from the AOK PLUS German sickness fund (1 January 2015– 31 December 2019). The index date was the first date of prescription for FF/UMEC/VI or BDP/GLY/FOR (SITT users), or the first date of overlap of inhaled corticosteroid, long-acting β2-agonist, and long-acting muscarinic antagonist (MITT users). Two cohorts were defined: the prevalent cohort included all identified triple therapy users; the incident cohort included patients newly initiating triple therapy for the first time (no prior use of MITT or SITT in the last 2 years). Patient characteristics and treatment patterns were assessed on the index date and during the 24-m

Gema Requena,1 Alexandrosz Czira,1 Victoria Banks,2 Robert Wood,2 Theo Tritton,2 Catherine Castillo,2 Jie Yeap,2 Rosie Wild,2 Chris Compton,1 Kieran J Rothnie,1 Felix JF Herth,3 Jennifer K Quint,4 Afisi S Ismaila5,6 1GSK, R&D Global Medical, Brentford, Middlesex, UK; 2Real-World Evidence, Adelphi Real World, Bollington, Cheshire, UK; 3Department of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg and Translational Lung Research Center Heidelberg, Heidelberg, Germany; 4National Heart and Lung Institute, Imperial College London, London, UK; 5Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 6Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Gema Requena, Epidemiology, Value Evidence and Outcomes, R&D Global Medical, GSK, Brentford, Middlesex, UK, Tel +44 20 80476893, Email gema.x.requena@gsk.comPurpose: Chronic obstructive pulmonary disease (COPD) exacerbations are associated with significant morbidity and mortality and increased economic healthcare burden for patients with COPD. Long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) dual therapy is recommended for patients receiving mono-bronchodilator therapy who experience exacerbations or ongoing breathlessness. This study compared two single-inhaler LAMA/LABA dual therapies, umeclidinium/vilanterol (UMEC/VI) and indacaterol/glycopyrronium (IND/GLY), on moderate-to-severe exacerbation rates in patients with COPD in England.Patients and Methods: This retrospective cohort study used linked primary care electronic health record data (Clinical Practice Research Datalink-Aurum) and secondary care data (Hospital Episode Statistics) to assess outcomes for patients with COPD who had a first prescription for single-inhaler UMEC/VI or IND/GLY (index date) between 1 January 2015 and 30 September 2019 (indexing period). Analyses compared UMEC/VI and IND/GLY on moderate-to-severe, moderate, and severe

Alexandrosz Czira,1 Shoko Akiyama,2 Takeo Ishii,2 Robert P Wood,3 Lucinda J Camidge,3 Hannah Wallis,3 Thomas Jennison,3 Rosie AC Wild,3 Masao Yarita,2 Kenichi Hashimoto,2 Kieran J Rothnie,1 Afisi S Ismaila4,5 1Value Evidence and Outcomes, R&D Global Medical, GSK, Brentford, Middlesex, UK; 2Value Evidence and Outcomes, Japan Medical and Development, GSK, Tokyo, Japan; 3Real-World Evidence, Adelphi Real World, Bollington, UK; 4Value Evidence and Outcomes, R&D Global Medical, GSK, Collegeville, PA, USA; 5Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Kieran J Rothnie, Value Evidence and Outcomes, R&D Global Medical, GSK, Brentford, Middlesex, TW8 9GS, UK, Tel +44 7920 369573, Email kieran.j.rothnie@gsk.comPurpose: There is currently limited evidence for the optimal timing of triple therapy initiation in Japan, which is crucial for optimizing strategies for the effective treatment of chronic obstructive pulmonary disease (COPD). This study assessed the impact of prompt vs delayed initiation of triple therapy following a COPD exacerbation on clinical and economic outcomes in patients in Japan.Patients and Methods: Retrospective cohort study of patients in the Medical Data Vision Co., Ltd. database initiating triple therapy as single-inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol or budesonide/glycopyrronium/formoterol) or multiple-inhaler triple therapy within 180 days of a moderate-to-severe exacerbation (index). For the main analysis, patients were categorized as prompt or delayed initiators, initiating triple therapy within 0– 30 days or 31– 180 days of index, respectively. Inverse probability of treatment weighting based on propensity scores was used to adjust for measured confounders between prompt and delayed cohorts.Results: For the main analysis, 610 (60.3%) and 402 (39.7%) patients were prompt and delayed initiators, respectively. The rate of subsequent mo

Kieran J Rothnie,1 Beade Numbere,1 Steven Gelwicks,2 Yifei Lu,1,3 Raj Sharma,4 Chris Compton,4 Afisi S Ismaila,2,5 Jennifer K Quint6 1Value Evidence and Outcomes, R&D Global Medical, GSK, London, UK; 2Value Evidence and Outcomes, R&D Global Medical, GSK, Collegeville, PA, USA; 3Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; 4Global Medical, GSK, London, UK; 5Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada; 6National Heart and Lung Institute, Imperial College London, London, UKCorrespondence: Kieran J Rothnie, Value Evidence and Outcomes, R&D Global Medical, GSK, 980 Great West Road, Brentford, Middlesex, London, TW8 9GS, UK, Tel +44 208 990 3439, Email kieran.j.rothnie@gsk.comPurpose: Risk factors for exacerbations of chronic obstructive pulmonary disease (COPD) have been previously characterized for patients with more severe cases of COPD. It is unclear how the risk of first exacerbation may best be identified in patients with less severe disease. This study investigated risk factors for first exacerbation among English patients with COPD classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) group A or B.Patients and Methods: A retrospective cohort study using data from the UK Clinical Practice Research Datalink (CPRD) AURUM linked to Hospital Episode Statistics. Patients with COPD aged ≥ 35 years and classified as GOLD group A or B (2020 criteria) from January 2013–December 2019 were eligible. Patients were required to have 24 months history in CPRD (baseline). Two cohorts were defined: cohort 1 included patients with no severe exacerbations during baseline; cohort 2 included patients with no moderate or severe exacerbations during baseline. Risk factors associated with severe, or combined moderate and severe exacerbation were examined for up to 5 years of follow-up.Results: Overall, 194,948 patients were included in cohort 1

Alexandrosz Czira,1 Sneha Purushotham,2 Ike Iheanacho,2 Kieran J Rothnie,1 Chris Compton,3 Afisi S Ismaila4,5 1Value Evidence and Outcomes, R&D Global Medical, GSK, Brentford, UK; 2Evidera, London, UK; 3Global Medical, GSK, London, UK; 4Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 5Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Alexandrosz Czira, Value Evidence and Outcomes, R&D Global Medical, GSK, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK, Tel +44 7788 351610, Email alexandrosz.x.czira@gsk.comBackground: Patients with mild or mild-to-moderate chronic obstructive pulmonary disease (COPD), defined as Global Initiative for Chronic Obstructive Lung Disease (GOLD) group A/B, are regarded as having a lower risk of experiencing multiple or severe exacerbations compared with patients classified as GOLD group C/D. Current guidelines suggest that patients in GOLD A/B should commence treatment with a bronchodilator; however, some patients within this population who have a higher disease burden may benefit from earlier introduction of dual bronchodilator or inhaled corticosteroid-containing therapies. This study aimed to provide research-based insights into the burden of disease experienced by patients classified as GOLD A/B, and to identify characteristics associated with poorer outcomes.Methods: A systematic literature review (SLR) was conducted to identify evidence (burden of disease and prevalence data) relating to the population of interest (patients with COPD classified as GOLD A/B).Results: A total of 79 full-text publications and four conference abstracts were included. In general, the rates of moderate and severe exacerbations were higher among patients in GOLD group B than among those in group A. Among patients classified as GOLD A/B, the risk of exacerbation was higher in those with more symptoms (modified Medical Research Council or COPD Assessment Test scales)

Alexandrosz Czira,1 Gema Requena,1 Victoria Banks,2 Robert Wood,2 Theo Tritton,2 Catherine M Castillo,2 Jie Yeap,2 Rosie Wild,2 Chris Compton,1 Kieran J Rothnie,1 Felix Herth,3,4 Jennifer K Quint,5 Afisi S Ismaila6,7 1R&D Global Medical, GSK, Brentford, Middlesex, UK; 2Real-World Evidence, Adelphi Real World, Bollington, Cheshire, UK; 3Department of Pulmonology and Respiratory Care Medicine, Thoraxklinik at the University of Heidelberg, Heidelberg, Germany; 4Translational Lung Research Center Heidelberg, Member of the German Center for Lung Research DZL, Heidelberg, Germany; 5National Heart and Lung Institute, Imperial College London, London, UK; 6Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 7Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Alexandrosz Czira, Value Evidence and Outcomes, R&D Global Medical, GSK, Brentford, Middlesex, UK, Tel +44 7788 351610, Email alexandrosz.x.czira@gsk.comPurpose: To compare adherence to once-daily umeclidinium/vilanterol (UMEC/VI), a long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA), and twice-daily inhaled corticosteroids (ICS)/LABA single-inhaler dual therapy in patients with chronic obstructive pulmonary disease (COPD) in a primary care cohort in England.Patients and Methods: Active comparator, new-user, retrospective cohort study using CPRD-Aurum primary care data and linked Hospital Episode Statistics secondary care administrative data. Patients without exacerbations in the previous year were indexed on first/earliest prescription date of once-daily UMEC/VI or twice-daily ICS/LABA as initial maintenance therapy between July 2014-September 2019. Primary outcome: medication adherence at 12 months post-index, defined as proportion of days covered (PDC) ≥ 80%. PDC represented proportion of time over the treatment duration that the patient was theoretically in possession of the medication. Secondary outcomes: adherence at

Kieran J Rothnie,1 Sandra Joksaite,1 Leah B Sansbury,2 Chris Compton,3 Valentina Di Boscio,4 Afisi S Ismaila5,6 1Value Evidence and Outcomes, R&D Global Medical, GlaxoSmithKline, London, UK; 2Value Evidence and Outcomes, R&D Global Medical, GlaxoSmithKline, Research Triangle Park, NC, USA; 3Global Medical Affairs, GlaxoSmithKline, Middlesex, UK; 4Global Medical Affairs, GlaxoSmithKline, Ealing, UK; 5Value Evidence and Outcomes, R&D Global Medical, GlaxoSmithKline, Collegeville, PA, USA; 6Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Kieran J Rothnie, Value Evidence and Outcomes, R&D Global Medical, GlaxoSmithKline, London, UK, Tel +44 208 990 3439, Email kieran.j.rothnie@gsk.comPurpose: Inhaled triple therapy is recommended for patients with chronic obstructive pulmonary disease (COPD) who have poorly controlled symptoms and to reduce the risk of exacerbations. This study assessed the clinical characteristics of new users of single- and multiple-inhaler triple therapy (SITT and MITT) treated in a primary care setting in England.Patients and Methods: This cross-sectional, observational study used data from an electronic health record database (CPRD Aurum) of COPD patients registered with a primary care practice in England, with linkage to a secondary care database. Patients were required to have initiated a new triple therapy (index) between November 2017 and November 2018 and have ≥ 12 months of available medical history prior to the index date.Results: In total, 3536 patients initiated fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) SITT for the first time: 65% had a Medical Research Council (MRC) dyspnea score ≥ 3, 45% had forced expiratory volume in 1 second (FEV1)% predicted < 50%, and 64% had a moderate or severe exacerbation in the previous 12 months. The majority (83%) of new FF/UMEC/VI users had a history of MITT use. Immediately prior to FF/UMEC/VI

David MG Halpin,1 Kieran J Rothnie,2 Victoria Banks,3 Alexandrosz Czira,2 Chris Compton,4 Robert Wood,3 Theo Tritton,3 Olivia Massey,3 Rosie Wild,3 Neil Snowise,5 Kirill Nikitin,2 Raj Sharma,4 Afisi S Ismaila,6,7 Claus F Vogelmeier8 1University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK; 2Value Evidence and Outcomes, R&D Global Medical, GSK, Brentford, UK; 3Real-World Evidence, Adelphi Real World, Bollington, UK; 4Global Medical, GSK, London, UK; 5Institute of Pharmaceutical Science, Faculty of Life Sciences and Medicine, King’s College, London, UK; 6Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 7Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada; 8Department of Medicine, Pulmonary and Critical Care Medicine, University of Marburg, Member of the German Center for Lung Research (DZL), Marburg, GermanyCorrespondence: David MG Halpin, University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, EX1 2LU, UK, Tel +44 (0)1392 201178, Email d.halpin@nhs.netPurpose: Triple therapy comprising a long-acting muscarinic antagonist, long-acting β2-agonist and inhaled corticosteroid is recommended for patients with chronic obstructive pulmonary disease (COPD) who continue to experience frequent exacerbations or symptoms whilst receiving dual therapy. Adherence and persistence to multiple-inhaler triple therapy (MITT) is known to be poor. This study assessed comparative adherence to single-inhaler triple therapy (SITT) versus MITT in a real-world setting in England.Patients and Methods: This was a retrospective cohort study using linked primary care (Clinical Practice Research Datalink Aurum) and secondary care (Hospital Episode Statistics [HES] Admitted Patient Care) data to identify patients with COPD who were newly initiated on SITT or MITT between November 2017 and June 2019. Eligible patients were aged ≥ 35 years and had

Leah B Sansbury,1 David A Lipson,2,3 Chanchal Bains,4 Glenn A Anley,5 Kieran J Rothnie,4 Afisi S Ismaila6,7 1Value Evidence and Outcomes, Epidemiology, R&D Global Medical, GlaxoSmithKline, Research Triangle Park, NC, USA; 2Respiratory Clinical Sciences, GlaxoSmithKline, Collegeville, PA, USA; 3Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; 4Value Evidence and Outcomes, R&D Global Medical, GlaxoSmithKline, Uxbridge, UK; 5UK Health Outcomes, GlaxoSmithKline, Uxbridge, UK; 6Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, PA, USA; 7Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S Ismaila, Value Evidence and Outcomes, GlaxoSmithKline, 1250 South Collegeville Road, Collegeville, PA, 19426-0989, USA, Tel +1 919 315 8229, Email afisi.s.ismaila@gsk.comPurpose: Clinical guidelines for COPD management suggest pharmacologic treatment algorithms based on symptoms and exacerbation history. As previous research has suggested that prescribing patterns are not always aligned with these recommendations, this study investigated the burden of disease in patients with COPD receiving, and persisting on, new inhaled maintenance therapy.Patients and Methods: This was a retrospective observational study using two linked electronic databases containing health records of patients in England. Patients aged ≥ 35 years with a confirmed diagnosis of COPD, and who initiated a new inhaled respiratory pharmacologic maintenance regimen between January 1, 2014 and December 31, 2016 (index date) were eligible for inclusion. New treatments could be long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) monotherapy, inhaled corticosteroid (ICS)/LABA or LAMA/LABA dual therapy, or a multiple-inhaler triple therapy (MITT; LAMA/LABA/ICS). Patients were required to have 12 months of available medical history prior to, and after, the index date.Results: In total

Leah B Sansbury,1 Kieran J Rothnie,2 Chanchal Bains,3 Chris Compton,4 Glenn Anley,2 Afisi S Ismaila5,6 1Value Evidence and Outcomes, GlaxoSmithKline, Research Triangle Park, Durham, NC, USA; 2Value and Evidence Outcomes, GlaxoSmithKline, Uxbridge, UK; 3Real World Evidence and Epidemiology, GlaxoSmithKline, Uxbridge, UK; 4Global Respiratory Franchise, GlaxoSmithKline, Brentford, UK; 5Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, PA, USA; 6Department of Health Research Methods, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S IsmailaValue Evidence and Outcomes, GlaxoSmithKline, 1250 South Collegeville Road, Collegeville, PA, 19426-0989, USATel +1 919 315 8229Email afisi.s.ismaila@gsk.comBackground: Available data on the relationship between COPD symptoms, disease outcomes, and mortality are currently limited. This study investigated the clinical characteristics, outcomes, healthcare utilization, and prescribing practices across GOLD 2017 groups (A, B, C, and D) in a large-scale, population-based cohort of COPD patients managed in an English primary care setting.Patients and Methods: This retrospective analysis included patients aged ≥ 35 years, with a confirmed diagnosis of COPD and ≥ 1 record of pulmonary function testing in their medical history. Medical Research Council dyspnea score and exacerbation history were used to define patients’ GOLD 2017 classification. Patients were identified using the UK Clinical Practice Research Database and were followed for 12 months.Results: Eligible COPD patients’ (N=42,331; mean [SD] age, 69.5 [10.7] years; 54% males), GOLD 2017 categorizations were: Group A: 49.1%, Group B: 30.5%, Group C: 8.2%, Group D: 12.1%. Overall, 37.7% of patients experienced ≥ 1 moderate COPD exacerbation. The rate of moderate exacerbations per person per year (PPPY) was highest in GOLD group D (0.72), followed by C (0.53), B (0.22), and A (0.15), while the rate of exacerbations leading to hospitalization PPPY w

Douglas W Mapel,1,* Melissa H Roberts,1,* Susan Sama,2 Priyanka J Bobbili,3 Wendy Y Cheng,3 Mei Sheng Duh,3 Catherine Nguyen,3 Philippe Thompson-Leduc,3 Melissa K Van Dyke,4 Kieran J Rothnie,4 Devi Sundaresan,2 Julia M Certa,5 Thomas S Whiting,5 Jennifer L Brown,5 Douglas W Roblin5 1College of Pharmacy, University of New Mexico, Albuquerque, NM, USA; 2Reliant Medical Group, Inc., Worcester, MA, USA; 3Analysis Group, Inc., Boston, MA, USA; 4GlaxoSmithKline plc., London, UK; 5Kaiser Permanente Mid-Atlantic States (KPMAS), Mid-Atlantic Permanente Research Institute (MAPRI), Rockville, MD, USA*These authors contributed equally to this workCorrespondence: Melissa H RobertsCollege of Pharmacy, University of New Mexico, 2502 Marble Ave, Albuquerque, NM, 87106, USATel +1 505 925-0953Email MHRoberts@salud.unm.eduIntroduction: Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are important events that may precipitate other adverse outcomes. Accurate AECOPD event identification in electronic administrative data is essential for improving population health surveillance and practice management.Objective: Develop codified algorithms to identify moderate and severe AECOPD in two US healthcare systems using administrative data and electronic medical records, and validate their performance by calculating positive predictive value (PPV) and negative predictive value (NPV).Methods: Data from two large regional integrated health systems were used. Eligible patients were identified using International Classification of Diseases (Ninth Edition) COPD diagnosis codes. Two algorithms were developed: one to identify potential moderate AECOPD by selecting outpatient/emergency visits associated with AECOPD-related codes and antibiotic/systemic steroid prescriptions; the other to identify potential severe AECOPD by selecting inpatient visits associated with corresponding codes. Algorithms were validated via patient chart review, adjudicated by a pulmonologist. To estimate PP