Evidence map›Paper›PMID 35698725›Full record

ArticleThe Lancet. Rheumatology2022

Risk of severe COVID-19 outcomes associated with immune-mediated inflammatory diseases and immune-modifying therapies: a nationwide cohort study in the OpenSAFELY platform.

Brian MacKenna, Nicholas A Kennedy, Amir Mehrkar, Anna Rowan, James Galloway, Julian Matthewman, Kathryn E Mansfield, Katie Bechman, Mark Yates, Jeremy Brown and 38 more

Registry-linked trialOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Lancet. Rheumatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06683937 (Evaluation of Direct Antiviral Treatments Against SARS-CoV-2 in Immunocompromised Patients With Covid-19. A G2i Study, National Multicenter Observational and Retrospective From June 2023 to April 2024), which is not on this map. Cited by 63 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 1 pooled it
10.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06683937 not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Evaluation of Direct Antiviral Treatments Against SARS-CoV-2 in Immunocompromised Patients With Covid-19. A G2i Study, National Multicenter Observational and Retrospective From June 2023 to April 2024

TypeobservationalSponsorAssistance Publique - Hôpitaux de ParisRan2025 to 2026Enrolled300ConditionsImmunocompromised Patients, SARS-CoV-2 DiseaseArmsCollection of data from the patient's medical file
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 1 synthesis or guideline pooled it, 106 citations in OpenAlex.

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3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

48 authors at 8 institutions in 1 country.

Brian MacKennaThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Nicholas A KennedyDepartment of Gastroenterology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.
Amir MehrkarThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Anna RowanThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
James GallowayCentre of Rheumatic Diseases, King's College London, London, UK.
Julian MatthewmanFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Kathryn E MansfieldFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Katie BechmanCentre of Rheumatic Diseases, King's College London, London, UK.
Mark YatesCentre of Rheumatic Diseases, King's College London, London, UK.
Jeremy BrownFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Anna SchultzeFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Sam NortonCentre of Rheumatic Diseases, King's College London, London, UK.
Alex J WalkerThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Caroline E MortonThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
David HarrisonIntensive Care National Audit and Research Centre, London, UK.
Krishnan BhaskaranFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Christopher T RentschFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Elizabeth WilliamsonFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Richard CrokerThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Seb BaconThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
George HickmanThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Tom WardThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Simon DavyThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Amelia GreenThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Louis FisherThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
William HulmeThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Chris BatesTPP, Leeds, UK.
Helen J CurtisThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
John TazareFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Rosalind M EggoFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
David EvansThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Peter InglesbyThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Jonathan CockburnTPP, Leeds, UK.
Helen I McDonaldFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Laurie A TomlinsonFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Rohini MathurFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Angel Y S WongFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Harriet ForbesFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
John ParryTPP, Leeds, UK.
Frank HesterTPP, Leeds, UK.
Sam HarperTPP, Leeds, UK.
Ian J DouglasFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Liam SmeethFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Charlie W LeesCentre for Genomics and Experimental Medicine, University of Edinburgh Western General Hospital, Edinburgh, UK.
Stephen J W EvansFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Ben GoldacreThe Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Catherine H SmithSt John's Institute of Dermatology, King's College London, London, UK.
Sinéad M LanganFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
London School of Hygiene & Tropical Medicine · GBUniversity of Oxford · GBWPP (United Kingdom) · GBKing's College London · GBGuy's and St Thomas' NHS Foundation Trust · GBIntensive Care National Audit & Research Centre · GBRoyal Devon & Exeter NHS Foundation Trust · GBWestern General Hospital · GB

Funding

Medical Research Council MC_PC_20058Medical Research Council MR/S003975/1Medical Research Council MR/S034919/1Medical Research Council MR/V015737/1
6 · The paper itself

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/IL‑23 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· 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.

Identifiers

PMID35698725
PMCPMC9179144
OpenAlexW4282916578

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.