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Risk of severe COVID-19 outcomes associated with immune-mediated inflammatory diseases and immune-modifying therapies: a nationwide cohort study in the OpenSAFELY platform.
MacKenna, Brian; Kennedy, Nicholas A; Mehrkar, Amir; Rowan, Anna; Galloway, James; Matthewman, Julian; Mansfield, Kathryn E; Bechman, Katie; Yates, Mark; Brown, Jeremy; Schultze, Anna; Norton, Sam; Walker, Alex J; Morton, Caroline E; Harrison, David; Bhaskaran, Krishnan; Rentsch, Christopher T; Williamson, Elizabeth; Croker, Richard; Bacon, Seb; Hickman, George; Ward, Tom; Davy, Simon; Green, Amelia; Fisher, Louis; Hulme, William; Bates, Chris; Curtis, Helen J; Tazare, John; Eggo, Rosalind M; Evans, David; Inglesby, Peter; Cockburn, Jonathan; McDonald, Helen I; Tomlinson, Laurie A; Mathur, Rohini; Wong, Angel Y S; Forbes, Harriet; Parry, John; Hester, Frank; Harper, Sam; Douglas, Ian J; Smeeth, Liam; Lees, Charlie W; Evans, Stephen J W; Goldacre, Ben; Smith, Catherine H; Langan, Sinéad M.
  • MacKenna B; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Kennedy NA; Department of Gastroenterology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.
  • Mehrkar A; IBD Research Group, University of Exeter, Exeter, UK.
  • Rowan A; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Galloway J; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Matthewman J; Centre of Rheumatic Diseases, King's College London, London, UK.
  • Mansfield KE; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Bechman K; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Yates M; Centre of Rheumatic Diseases, King's College London, London, UK.
  • Brown J; Centre of Rheumatic Diseases, King's College London, London, UK.
  • Schultze A; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Norton S; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Walker AJ; Centre of Rheumatic Diseases, King's College London, London, UK.
  • Morton CE; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Harrison D; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Bhaskaran K; Intensive Care National Audit and Research Centre, London, UK.
  • Rentsch CT; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Williamson E; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Croker R; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Bacon S; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Hickman G; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Ward T; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Davy S; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Green A; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Fisher L; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Hulme W; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Bates C; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Curtis HJ; TPP, Leeds, UK.
  • Tazare J; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Eggo RM; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Evans D; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Inglesby P; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Cockburn J; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • McDonald HI; TPP, Leeds, UK.
  • Tomlinson LA; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Mathur R; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Wong AYS; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Forbes H; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Parry J; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Hester F; TPP, Leeds, UK.
  • Harper S; TPP, Leeds, UK.
  • Douglas IJ; TPP, Leeds, UK.
  • Smeeth L; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Lees CW; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Evans SJW; Centre for Genomics and Experimental Medicine, University of Edinburgh Western General Hospital, Edinburgh, UK.
  • Goldacre B; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Smith CH; The Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Langan SM; St John's Institute of Dermatology, King's College London, London, UK.
Lancet Rheumatol ; 4(7): e490-e506, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1882682
ABSTRACT

Background:

The risk of severe COVID-19 outcomes in people with immune-mediated inflammatory diseases and on immune-modifying drugs might not be fully mediated by comorbidities and might vary by factors such as ethnicity. We aimed to assess the risk of severe COVID-19 in adults with immune-mediated inflammatory diseases and in those on immune-modifying therapies.

Methods:

We did a cohort study, using OpenSAFELY (an analytics platform for electronic health records) and TPP (a software provider for general practitioners), analysing routinely collected primary care data linked to hospital admission, death, and previously unavailable hospital prescription data. We included people aged 18 years or older on March 1, 2020, who were registered with TPP practices with at least 12 months of primary care records before March, 2020. We used Cox regression (adjusting for confounders and mediators) to estimate hazard ratios (HRs) comparing the risk of COVID-19-related death, critical care admission or death, and hospital admission (from March 1 to Sept 30, 2020) in people with immune-mediated inflammatory diseases compared with the general population, and in people with immune-mediated inflammatory diseases on targeted immune-modifying drugs (eg, biologics) compared with those on standard systemic treatment (eg, methotrexate).

Findings:

We identified 17 672 065 adults; 1 163 438 adults (640 164 [55·0%] women and 523 274 [45·0%] men, and 827 457 [71·1%] of White ethnicity) had immune-mediated inflammatory diseases, and 16 508 627 people (8 215 020 [49·8%] women and 8 293 607 [50·2%] men, and 10 614 096 [64·3%] of White ethnicity) were included as the general population. Of 1 163 438 adults with immune-mediated inflammatory diseases, 19 119 (1·6%) received targeted immune-modifying therapy and 181 694 (15·6%) received standard systemic therapy. Compared with the general population, adults with immune-mediated inflammatory diseases had an increased risk of COVID-19-related death after adjusting for confounders (age, sex, deprivation, and smoking status; HR 1·23, 95% CI 1·20-1·27) and further adjusting for mediators (body-mass index [BMI], cardiovascular disease, diabetes, and current glucocorticoid use; 1·15, 1·11-1·18). Adults with immune-mediated inflammatory diseases also had an increased risk of COVID-19-related critical care admission or death (confounder-adjusted HR 1·24, 95% CI 1·21-1·28; mediator-adjusted 1·16, 1·12-1·19) and hospital admission (confounder-adjusted 1·32, 1·29-1·35; mediator-adjusted 1·20, 1·17-1·23). In post-hoc analyses, the risk of severe COVID-19 outcomes in people with immune-mediated inflammatory diseases was higher in non-White ethnic groups than in White ethnic groups (as it was in the general population). We saw no evidence of increased COVID-19-related death in adults on targeted, compared with those on standard systemic, therapy after adjusting for confounders (age, sex, deprivation, BMI, immune-mediated inflammatory diseases [bowel, joint, and skin], cardiovascular disease, cancer [excluding non-melanoma skin cancer], stroke, and diabetes (HR 1·03, 95% CI 0·80-1·33), and after additionally adjusting for current glucocorticoid use (1·01, 0·78-1·30). There was no evidence of increased COVID-19-related death in adults prescribed tumour necrosis factor inhibitors, interleukin (IL)-12/IL­23 inhibitors, IL-17 inhibitors, IL-6 inhibitors, or Janus kinase inhibitors compared with those on standard systemic therapy. Rituximab was associated with increased COVID-19-related death (HR 1·68, 95% CI 1·11-2·56), with some attenuation after excluding people with haematological malignancies or organ transplants (1·54, 0·95-2·49).

Interpretation:

COVID-19 deaths and hospital admissions were higher in people with immune-mediated inflammatory diseases. We saw no increased risk of adverse COVID-19 outcomes in those on most targeted immune-modifying drugs for immune-mediated inflammatory diseases compared with those on standard systemic therapy.

Funding:

UK Medical Research Council, NIHR Biomedical Research Centre at King's College London and Guy's and St Thomas' NHS Foundation Trust, and Wellcome Trust.

Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Language: English Journal: Lancet Rheumatol Year: 2022 Document Type: Article Affiliation country: S2665-9913(22)00098-4

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Language: English Journal: Lancet Rheumatol Year: 2022 Document Type: Article Affiliation country: S2665-9913(22)00098-4