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Pragmatic and Observational Research Volume 15, 2024 - Issue
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ORIGINAL RESEARCH

Risk of Pneumonia in Patients with COPD Initiating Fixed Dose Inhaled Corticosteroid (ICS) / Long-Acting Bronchodilator (LABD) Formulations Containing Extrafine Beclometasone Dipropionate versus Patients Initiating LABD Without ICS

David Price1 Observational and Pragmatic Research Institute, Singapore;2 Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UKCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0002-9728-9992View further author information
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William Henley1 Observational and Pragmatic Research Institute, Singapore;3 Health Statistics Group, Department of Health and Community Sciences, University of Exeter Medical School, Exeter, UKView further author information
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José Eduardo Delfini Cançado4 Santa Casa de São Paulo Medical School, São Paulo, BrazilORCID Iconhttps://orcid.org/0000-0003-1238-8498View further author information
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Leonardo M Fabbri5 Respiratory Medicine, Department of Translational Medicine and for Romagna, University of Ferrara, Ferrara, ItalyORCID Iconhttps://orcid.org/0000-0001-8894-1689View further author information
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Huib AM Kerstjens6 Department of Pulmonary Diseases, University of Groningen and University Medical Centre Groningen, and Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, the NetherlandsORCID Iconhttps://orcid.org/0000-0001-7705-7927View further author information
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Alberto Papi7 Respiratory Medicine, University of Ferrara, Ferrara, ItalyORCID Iconhttps://orcid.org/0000-0002-6924-4500View further author information
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Nicolas Roche8 Department of Respiratory Medicine, APHP-Centre University of Paris, Cochin Hospital and Institute (UMR1016), Paris, FranceORCID Iconhttps://orcid.org/0000-0002-3162-5033View further author information
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Elif Şen9 Department of Pulmonary Medicine, Ankara University School of Medicine, Ankara, TurkeyView further author information
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Dave Singh10 Division of Infection, Immunity & Respiratory Medicine, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UKView further author information
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Claus F Vogelmeier11 Department of Internal Medicine, Pulmonary and Critical Care Medicine, University of Marburg, Member of the German Centre for Lung Research (DZL), Marburg, GermanyView further author information
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Elena Nudo12 Global Medical Affairs, Chiesi Farmaceutici, S.p.A, Parma, ItalyView further author information
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Victoria Carter1 Observational and Pragmatic Research Institute, SingaporeView further author information
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Derek Skinner1 Observational and Pragmatic Research Institute, SingaporeORCID Iconhttps://orcid.org/0000-0002-7112-9317View further author information
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Rebecca Vella1 Observational and Pragmatic Research Institute, SingaporeORCID Iconhttps://orcid.org/0000-0001-5221-3524View further author information
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Joan B Soriano13 Respiratory Department, Hospital Universitario de La Princesa and Facultad de Medicina, Universidad Autónoma de Madrid, Madrid, SpainView further author information
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Maxim Kots12 Global Medical Affairs, Chiesi Farmaceutici, S.p.A, Parma, ItalyView further author information
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George Georges14 Global Clinical Development, Chiesi Farmaceutici, S.p.A, Parma, ItalyORCID Iconhttps://orcid.org/0000-0002-0303-2273View further author information
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Pages 1-16 | Received 31 Aug 2023, Accepted 28 Dec 2023, Published online: 19 Jan 2024

Figures & data

Table 1 Demographic Features of Unmatched and Matched Populations Commencing Formulations Containing Extrafine Beclometasone/Long-Acting Bronchodilators (Ef-BDP/LABD) or Long-Acting Bronchodilators (LABD)

Figure 1 (A) Flow diagrams for patients commencing (A) LABD or (B) ef-BDP/LABD therapy and their eligibility for matching. (B) Flow diagrams for patients commencing (A) LABD or (B) ef-BDP/LABD therapy and their eligibility for matching.

Abbreviations: COPD, chronic obstructive pulmonary disease; ef-BDP/LABD, extrafine beclometasone / long-acting bronchodilators; ICS, inhaled corticosteroids; LABD, long-acting bronchodilators.
Figure 1 (A) Flow diagrams for patients commencing (A) LABD or (B) ef-BDP/LABD therapy and their eligibility for matching. (B) Flow diagrams for patients commencing (A) LABD or (B) ef-BDP/LABD therapy and their eligibility for matching.

Figure 2 Density plots showing the distribution of propensity scores for patients treated with formulations containing extrafine beclometasone/long-acting bronchodilators (ef-BDP/LABD) or long-acting bronchodilators (LABD) without ICS.

Notes: Density plots showing the distribution of propensity scores for patients treated with extrafine particle fixed dose beclometasone (ef-FDC-BDP) and LABD. The propensity score represents the estimated probability that each patient is assigned to fp-FDC-F treatment, based on their baseline characteristics (with possible values ranging from 0 to 1). A rug plot is shown along the x-axis, with a circle representing the propensity score for each patient, providing a compact visualisation of the range of propensity score values for each treatment (range of propensity scores for LABD: 0.09–0.94; range of propensity scores for LABD: 0.12–0.96).
Abbreviations: LABD, long-acting bronchodilators; FDC, Fixed Dose Combination.
Figure 2 Density plots showing the distribution of propensity scores for patients treated with formulations containing extrafine beclometasone/long-acting bronchodilators (ef-BDP/LABD) or long-acting bronchodilators (LABD) without ICS.

Figure 3 Covariate plot showing standardised mean differences (SMD) for comparison of baseline characteristics for new users of formulations containing extrafine beclometasone/long-acting bronchodilators or long-acting bronchodilators without ICS before and after propensity score matching.

Notes: acute_ocs, number of acute oral corticosteroid prescriptions; days_prior, number of days available in-patient record prior to index date; ocs_maintenance, number of maintenance oral corticosteroid prescriptions in baseline period.
Abbreviations: BMI, body mass index; CKD, chronic kidney disease; FEV1, forced expiratory volume in one second; GERD, Gastro-esophageal reflux disease; GOLD, Global Initiative for Chronic Obstructive Lung Disease; IHD, ischemic heart disease; LAMA, long acting muscarinic antagonist; LTRA, Leukotriene receptor antagonists; MRC, Medical Research Council; OCS, oral corticosteroids; PS, propensity score; SABA, short-acting beta-agonist; SAMA, short acting muscarinic antagonist; SMD, standardised mean difference.
Figure 3 Covariate plot showing standardised mean differences (SMD) for comparison of baseline characteristics for new users of formulations containing extrafine beclometasone/long-acting bronchodilators or long-acting bronchodilators without ICS before and after propensity score matching.

Table 2 Hazard Ratios for Comparing Time-to-Event Outcomes for New Users of Formulations Containing Either Extrafine Beclometasone/Long-Acting Bronchodilators (Ef-BDP/LABD) or Long-Acting Bronchodilators (LABD) in Propensity Score Matched Samples

Figure 4 Hazard ratios for sensitive- and specific-pneumonia definitions for extrafine beclometasone/long-acting bronchodilators or long acting bronchodilators (LABD) in unmatched and propensity score matched analyses.

Abbreviations: CI, Confidence Interval; ef-BDP/LABD, extrafine beclometasone/long-acting bronchodilators; LABD, long-acting bronchodilators; PSM, propensity score matched.
Figure 4 Hazard ratios for sensitive- and specific-pneumonia definitions for extrafine beclometasone/long-acting bronchodilators or long acting bronchodilators (LABD) in unmatched and propensity score matched analyses.

Figure 5 Kaplan-Meier survival curves for the time to pneumonia (sensitive definition) for new users of FDC extrafine beclometasone/long acting bronchodilators or long acting bronchodilators (LABD) in propensity score matched samples (as-treated).

Abbreviations: ef-BDP/LABD, extrafine beclometasone/long-acting bronchodilators; LABD, long-acting bronchodilators.
Figure 5 Kaplan-Meier survival curves for the time to pneumonia (sensitive definition) for new users of FDC extrafine beclometasone/long acting bronchodilators or long acting bronchodilators (LABD) in propensity score matched samples (as-treated).

Figure 6 Kaplan-Meier survival curves for the time to pneumonia (specific definition) for new users of FDC extrafine beclometasone/long acting bronchodilators or long acting bronchodilators (LABD) in propensity score matched samples (as-treated).

Abbreviations: ef-BDP/LABD, extrafine beclometasone/long-acting bronchodilators; LABD, long-acting bronchodilators.
Figure 6 Kaplan-Meier survival curves for the time to pneumonia (specific definition) for new users of FDC extrafine beclometasone/long acting bronchodilators or long acting bronchodilators (LABD) in propensity score matched samples (as-treated).

Figure 7 Kaplan-Meier survival curves for the time to lower respiratory tract infection (LRTI) for new users of FDC extrafine beclometasone/long acting bronchodilators or long acting bronchodilators (LABD) in propensity score matched samples (as-treated).

Abbreviations: ef-BDP/LABD, extrafine beclometasone/long-acting bronchodilators; LABD, long-acting bronchodilators; LRTI, lower respiratory tract infection.
Figure 7 Kaplan-Meier survival curves for the time to lower respiratory tract infection (LRTI) for new users of FDC extrafine beclometasone/long acting bronchodilators or long acting bronchodilators (LABD) in propensity score matched samples (as-treated).

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