Higher rate of COVID-19 deaths before vaccination

People with certain inflammatory immune diseases affecting the joints, gut and skin, such as rheumatoid arthritis, may have been at higher risk of dying or needing hospital care if they had contracted COVID-19 before vaccination compared to the general population, according to a new study Posted in The Lancet Rheumatology.

The findings are based on analysis of 17 million GP records in England during the first phase of the pandemic from March to September 2020, when the UK was in lockdown and before vaccines were released. available. Since then, many people treated with drugs analyzed in this study have been specifically targeted for third doses of the primary vaccine followed by boosters and are on a list of people who have been offered antiviral treatments.

The study was conducted by a team from the London School of Hygiene & Tropical Medicine (LSHTM) using the OpenSAFELY platform with colleagues from St John’s Institute of Dermatology at Guy’s and St Thomas’ NHS Foundation Trust, University of Oxford, King’s College London, the University of Exeter and the University of Edinburgh.

More than one million patients in the analysis suffered from immune-mediated inflammatory diseases (IMID). These included inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis, conditions affecting the joints such as rheumatoid arthritis, and skin conditions such as psoriasis.

After controlling for age, gender, deprivation, and smoking status, research suggests that people with IMID affecting the gut, joints, and skin had a 23% increased risk of death related to COVID-19 and a 23% increased risk of COVID-related hospitalization compared to people without IMID before the introduction of vaccines and antiviral treatments. People with inflammatory joint disease appeared to be most at risk compared to those with bowel or skin disease. Compared to the general population, the researchers estimated the risk of death to be about eight additional deaths per 1,000 people with joint disease in one year (disregarding other differences between people with and without the disease). joint, for example age and other health conditions).

Study author Professor Sinéad Langan, Wellcome Senior Clinical Fellow and Professor of Clinical Epidemiology at LSHTM, said: “At the height of the pandemic in England in 2020, many people with inflammatory conditions affecting the gut, joints and skin were told to stay home and protect because doctors didn’t know how COVID-19 would affect them, or what the effects of drugs such as immunomodulating therapies used to treat IMID would be .

“Our study provides the most accurate assessment of the risk of severe COVID-19 before vaccination in people with IMID and with the drugs used for their treatment. We hope this analysis will help inform evidence-based policy as we continue to live with COVID-19. »

The team also studied the impact of certain drugs, identifying around 200,000 people who were taking immunomodulating drugs. The study found that there was no increased overall risk of death or hospitalization from COVID-19 for patients taking the most targeted immunomodifying drugs (often called biologics) compared to standard systemic drugs ( that act on the immune system at large) administered to treat this group of conditions. For example, there was no increase in serious COVID-19 infections (death, ICU admission or death, or hospitalization) in people taking most of the targeted immunomodifying therapies examined – including anti- TNF such as adalimumab – compared to more commonly used standard treatments. immunosuppressants such as methotrexate.

Professor Catherine Smith, Consultant Dermatologist at Guy’s and St Thomas’ NHS Foundation Trust’s St John’s Institute of Dermatology, said: ‘We know that certain factors, such as being older, increase a person’s risk of suffer from a severe COVID-19 infection. But until now, we didn’t know if the risk of severe COVID-19 increases with persistent health problems related to immune system problems such as arthritis, Crohn’s disease and psoriasis.

“Our study provides important information that will help guide policy makers to ensure that prevention strategies such as vaccination and early intervention treatments such as antivirals target those most at risk.

“Overall, our findings regarding immunomodulatory drugs are reassuring. It is important that people continue to take prescribed medications and discuss treatment decisions with their doctor and get vaccinated as recommended.

The OpenSAFELY platform accesses an unprecedented scale of accessible data through a trusted search environment to safeguard an individual’s privacy. It provides the full dataset of all raw clinical events at event level for all individuals at 40% of all GP practices in England, including all clinical tests, treatments, diagnoses and information and demographics linked to various hospital data sources, including, for the first time, a comprehensive drug dataset provided by hospitals.

This study was made possible by OpenSAFELY links to a new data source containing information on “high cost” drugs. Because of the way these specialist medicines are prescribed, for example through programs via home care companies, this means that they are usually not on the charts of GPs. The study marks the first time that researchers have been able to analyze this group of drugs in this way and highlights why access to this data is essential for research.

Co-author Dr Nick Kennedy, Consultant Gastroenterologist and Clinical Lecturer at the University of Exeter, said: “Our study is an example of the high quality collaborative research that has taken place during the pandemic. using OpenSafely’s innovative research platform. For patients with inflammatory bowel disease, the overall message is reassuring, although there was some increased risk of being hospitalized in those with COVID-19.

“Our research also shows that the targeted drugs we commonly use to treat Crohn’s disease and colitis are not associated with an increased risk of poor outcomes.”

The authors acknowledge the limitations of the study, including that people with these conditions may have protected or avoided infection with COVID-19 and that other health conditions such as cardiovascular disease and diabetes may affect COVID-19 outcomes for people with IMID, as well as the possibility of misclassification of prescriptions or medications in patient records.

This study was supported by funding from researchers from the UK Medical Research Council and the Wellcome Trust.

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Brian MacKenna*, Nicholas A Kennedy*, Amir Mehrkar*, Anna Rowan*, James Galloway*, Julian Matthewman*, Kathryn E Mansfield, Katie Bechman, Mark Yates, Jeremy Brown, Anna Schultze, Sam Norton, Alex J Walker, Caroline E Morton, David Harrison, Krishnan Bhaskaran, Christopher T Rentsch, Elizabeth Williamson, Richard Croker, Seb Bacon, George Hickman, Tom Ward, Simon Davy, Amelia Green, Louis Fisher, William Hulme, Chris Bates, Helen J Curtis, John Tazare, Rosalind M Eggo, David Evans, Peter Inglesby, Jonathan Cockburn, Helen I McDonald, Laurie A Tomlinson, Rohini Mathur, Angel YS Wong, Harriet Forbes, John Parry, Frank Hester, Sam Harper, Ian J Douglas, Liam Smeeth, Charlie W Lees, Stephen JW Evans†, Ben Goldacre†, Catherine Smith†, Sinéad M Langan†, Risk of serious consequences of COVID-19 associated with immune-mediated inflammatory diseases and immunomodulatory therapies: a national cohort study on the OpenSAFELY platform. The Lancet Rheumatology.

Post-embargo link for journalists: https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(22)00098-4/fulltext

About OpenSAFELY:

OpenSAFELY is a new, highly secure software platform built during the COVID-19 pandemic for secure analysis of electronic health record data in England. It was specifically designed to address concerns about patient privacy when conducting large-scale searches with patient records. Analysts write code in OpenSAFELY to answer important research questions without requiring direct access to underlying patient records; all code is automatically shared for other researchers to review and reuse; and all platform activity is publicly recorded. This secure and transparent approach to the use of medical data has received strong support from privacy advocates, including in Parliament, and from an independent citizens’ jury on data sharing during COVID-19, commissioned by the NHS and the National Data Guardian. OpenSAFELY is a collaboration between the Bennett Institute for Applied Data Science at the University of Oxford, the Electronic Health Records Research Group at the London School of Hygiene &Tropical Medicine, and electronic health record software providers TPP and EMIS, with NHS England acting as data controller. More information is available at OpenSAFELY.org.