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Risk of COVID-19-related death among patients with chronic obstructive pulmonary disease or asthma prescribed inhaled corticosteroids: an observational cohort study using the OpenSAFELY platform.
Lancet Respir Med. 2020 11; 8(11):1106-1120.LR

Abstract

BACKGROUND

Early descriptions of patients admitted to hospital during the COVID-19 pandemic showed a lower prevalence of asthma and chronic obstructive pulmonary disease (COPD) than would be expected for an acute respiratory disease like COVID-19, leading to speculation that inhaled corticosteroids (ICSs) might protect against infection with severe acute respiratory syndrome coronavirus 2 or the development of serious sequelae. We assessed the association between ICS and COVID-19-related death among people with COPD or asthma using linked electronic health records (EHRs) in England, UK.

METHODS

In this observational study, we analysed patient-level data for people with COPD or asthma from primary care EHRs linked with death data from the Office of National Statistics using the OpenSAFELY platform. The index date (start of follow-up) for both cohorts was March 1, 2020; follow-up lasted until May 6, 2020. For the COPD cohort, individuals were eligible if they were aged 35 years or older, had COPD, were a current or former smoker, and were prescribed an ICS or long-acting β agonist plus long-acting muscarinic antagonist (LABA-LAMA) as combination therapy within the 4 months before the index date. For the asthma cohort, individuals were eligible if they were aged 18 years or older, had been diagnosed with asthma within 3 years of the index date, and were prescribed an ICS or short-acting β agonist (SABA) only within the 4 months before the index date. We compared the outcome of COVID-19-related death between people prescribed an ICS and those prescribed alternative respiratory medications: ICSs versus LABA-LAMA for the COPD cohort, and low-dose or medium-dose and high-dose ICSs versus SABAs only in the asthma cohort. We used Cox regression models to estimate hazard ratios (HRs) and 95% CIs for the association between exposure categories and the outcome in each population, adjusted for age, sex, and all other prespecified covariates. We calculated e-values to quantify the effect of unmeasured confounding on our results.

FINDINGS

We identified 148 557 people with COPD and 818 490 people with asthma who were given relevant respiratory medications in the 4 months before the index date. People with COPD who were prescribed ICSs were at increased risk of COVID-19-related death compared with those prescribed LABA-LAMA combinations (adjusted HR 1·39 [95% CI 1·10-1·76]). Compared with those prescribed SABAs only, people with asthma who were prescribed high-dose ICS were at an increased risk of death (1·55 [1·10-2·18]), whereas those given a low or medium dose were not (1·14 [0·85-1·54]). Sensitivity analyses showed that the apparent harmful association we observed could be explained by relatively small health differences between people prescribed ICS and those not prescribed ICS that were not recorded in the database (e value lower 95% CI 1·43).

INTERPRETATION

Our results do not support a major role for regular ICS use in protecting against COVID-19-related death among people with asthma or COPD. Observed increased risks of COVID-19-related death can be plausibly explained by unmeasured confounding due to disease severity.

FUNDING

UK Medical Research Council.

Authors+Show Affiliations

London School of Hygiene & Tropical Medicine, London, UK.The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.London School of Hygiene & Tropical Medicine, London, UK.London School of Hygiene & Tropical Medicine, London, UK.London School of Hygiene & Tropical Medicine, London, UK.London School of Hygiene & Tropical Medicine, London, UK.The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.The Phoenix Partnership (TPP), TPP House, Leeds, UK.The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.The Phoenix Partnership (TPP), TPP House, Leeds, UK.London School of Hygiene & Tropical Medicine, London, UK; NIHR Health Protection Research Unit in Immunisation, London, UK.London School of Hygiene & Tropical Medicine, London, UK.London School of Hygiene & Tropical Medicine, London, UK.London School of Hygiene & Tropical Medicine, London, UK.London School of Hygiene & Tropical Medicine, London, UK.London School of Hygiene & Tropical Medicine, London, UK.The Phoenix Partnership (TPP), TPP House, Leeds, UK.The Phoenix Partnership (TPP), TPP House, Leeds, UK.The Phoenix Partnership (TPP), TPP House, Leeds, UK.London School of Hygiene & Tropical Medicine, London, UK.National Heart and Lung Institute, Imperial College London, London, UK.London School of Hygiene & Tropical Medicine, London, UK; NIHR Health Protection Research Unit in Immunisation, London, UK.London School of Hygiene & Tropical Medicine, London, UK.The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. Electronic address: ben.goldacre@phc.ox.ac.uk.No affiliation info available

Pub Type(s)

Journal Article
Observational Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32979987

Citation

Schultze, Anna, et al. "Risk of COVID-19-related Death Among Patients With Chronic Obstructive Pulmonary Disease or Asthma Prescribed Inhaled Corticosteroids: an Observational Cohort Study Using the OpenSAFELY Platform." The Lancet. Respiratory Medicine, vol. 8, no. 11, 2020, pp. 1106-1120.
Schultze A, Walker AJ, MacKenna B, et al. Risk of COVID-19-related death among patients with chronic obstructive pulmonary disease or asthma prescribed inhaled corticosteroids: an observational cohort study using the OpenSAFELY platform. Lancet Respir Med. 2020;8(11):1106-1120.
Schultze, A., Walker, A. J., MacKenna, B., Morton, C. E., Bhaskaran, K., Brown, J. P., Rentsch, C. T., Williamson, E., Drysdale, H., Croker, R., Bacon, S., Hulme, W., Bates, C., Curtis, H. J., Mehrkar, A., Evans, D., Inglesby, P., Cockburn, J., McDonald, H. I., ... Goldacre, B. (2020). Risk of COVID-19-related death among patients with chronic obstructive pulmonary disease or asthma prescribed inhaled corticosteroids: an observational cohort study using the OpenSAFELY platform. The Lancet. Respiratory Medicine, 8(11), 1106-1120. https://doi.org/10.1016/S2213-2600(20)30415-X
Schultze A, et al. Risk of COVID-19-related Death Among Patients With Chronic Obstructive Pulmonary Disease or Asthma Prescribed Inhaled Corticosteroids: an Observational Cohort Study Using the OpenSAFELY Platform. Lancet Respir Med. 2020;8(11):1106-1120. PubMed PMID: 32979987.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Risk of COVID-19-related death among patients with chronic obstructive pulmonary disease or asthma prescribed inhaled corticosteroids: an observational cohort study using the OpenSAFELY platform. AU - Schultze,Anna, AU - Walker,Alex J, AU - MacKenna,Brian, AU - Morton,Caroline E, AU - Bhaskaran,Krishnan, AU - Brown,Jeremy P, AU - Rentsch,Christopher T, AU - Williamson,Elizabeth, AU - Drysdale,Henry, AU - Croker,Richard, AU - Bacon,Seb, AU - Hulme,William, AU - Bates,Chris, AU - Curtis,Helen J, AU - Mehrkar,Amir, AU - Evans,David, AU - Inglesby,Peter, AU - Cockburn,Jonathan, AU - McDonald,Helen I, AU - Tomlinson,Laurie, AU - Mathur,Rohini, AU - Wing,Kevin, AU - Wong,Angel Y S, AU - Forbes,Harriet, AU - Parry,John, AU - Hester,Frank, AU - Harper,Sam, AU - Evans,Stephen J W, AU - Quint,Jennifer, AU - Smeeth,Liam, AU - Douglas,Ian J, AU - Goldacre,Ben, AU - ,, Y1 - 2020/09/24/ PY - 2020/06/24/received PY - 2020/08/20/revised PY - 2020/08/25/accepted PY - 2020/9/28/pubmed PY - 2020/11/18/medline PY - 2020/9/27/entrez SP - 1106 EP - 1120 JF - The Lancet. Respiratory medicine JO - Lancet Respir Med VL - 8 IS - 11 N2 - BACKGROUND: Early descriptions of patients admitted to hospital during the COVID-19 pandemic showed a lower prevalence of asthma and chronic obstructive pulmonary disease (COPD) than would be expected for an acute respiratory disease like COVID-19, leading to speculation that inhaled corticosteroids (ICSs) might protect against infection with severe acute respiratory syndrome coronavirus 2 or the development of serious sequelae. We assessed the association between ICS and COVID-19-related death among people with COPD or asthma using linked electronic health records (EHRs) in England, UK. METHODS: In this observational study, we analysed patient-level data for people with COPD or asthma from primary care EHRs linked with death data from the Office of National Statistics using the OpenSAFELY platform. The index date (start of follow-up) for both cohorts was March 1, 2020; follow-up lasted until May 6, 2020. For the COPD cohort, individuals were eligible if they were aged 35 years or older, had COPD, were a current or former smoker, and were prescribed an ICS or long-acting β agonist plus long-acting muscarinic antagonist (LABA-LAMA) as combination therapy within the 4 months before the index date. For the asthma cohort, individuals were eligible if they were aged 18 years or older, had been diagnosed with asthma within 3 years of the index date, and were prescribed an ICS or short-acting β agonist (SABA) only within the 4 months before the index date. We compared the outcome of COVID-19-related death between people prescribed an ICS and those prescribed alternative respiratory medications: ICSs versus LABA-LAMA for the COPD cohort, and low-dose or medium-dose and high-dose ICSs versus SABAs only in the asthma cohort. We used Cox regression models to estimate hazard ratios (HRs) and 95% CIs for the association between exposure categories and the outcome in each population, adjusted for age, sex, and all other prespecified covariates. We calculated e-values to quantify the effect of unmeasured confounding on our results. FINDINGS: We identified 148 557 people with COPD and 818 490 people with asthma who were given relevant respiratory medications in the 4 months before the index date. People with COPD who were prescribed ICSs were at increased risk of COVID-19-related death compared with those prescribed LABA-LAMA combinations (adjusted HR 1·39 [95% CI 1·10-1·76]). Compared with those prescribed SABAs only, people with asthma who were prescribed high-dose ICS were at an increased risk of death (1·55 [1·10-2·18]), whereas those given a low or medium dose were not (1·14 [0·85-1·54]). Sensitivity analyses showed that the apparent harmful association we observed could be explained by relatively small health differences between people prescribed ICS and those not prescribed ICS that were not recorded in the database (e value lower 95% CI 1·43). INTERPRETATION: Our results do not support a major role for regular ICS use in protecting against COVID-19-related death among people with asthma or COPD. Observed increased risks of COVID-19-related death can be plausibly explained by unmeasured confounding due to disease severity. FUNDING: UK Medical Research Council. SN - 2213-2619 UR - https://www.unboundmedicine.com/medline/citation/32979987/Risk_of_COVID_19_related_death_among_patients_with_chronic_obstructive_pulmonary_disease_or_asthma_prescribed_inhaled_corticosteroids:_an_observational_cohort_study_using_the_OpenSAFELY_platform_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2213-2600(20)30415-X DB - PRIME DP - Unbound Medicine ER -