TY - JOUR
T1 - IVIg-exposure and thromboembolic event risk
T2 - findings from the UK Biobank
AU - Kapoor, Mahima
AU - Hunt, Ian
AU - Spillane, Jennifer
AU - Bonnett, Laura Jayne
AU - Hutton, Elspeth Jane
AU - McFadyen, James
AU - Westwood, John Paul
AU - Lunn, Michael P.
AU - Carr, Aisling S.
AU - Reilly, Mary M.
N1 - Funding Information:
1MRC Centre for Neuromuscular Diseases, UCL Queen Square Institute of Neurology, London, UK 2Department of Neurosciences, Monash University Central Clinical School, Melbourne, Victoria, Australia 3Tasmanian Institute of Agriculture, University of Tasmania, Hobart, Tasmania, Australia 4Neurology, Royal Free Hospital Foundation Trust, London, UK 5MRC Centre for Neuromuscular Diseases, National Hospital for Neurology and Neurosurgery and UCL Queen Square Institute of Neurology, London, UK 6Biostatistics, University of Liverpool, Liverpool, UK 7Neurology, Alfred Health, Melbourne, Victoria, Australia 8Neuroscience, Monash University, Melbourne, Victoria, Australia 9Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia 10Department of Clinical Hematology, The Alfred Hospital, Melbourne, Victoria, Australia 11Department of Haematology, University College London Hospital, London, UK 12MRC Centre for Neuromuscular Disease and Department of Molecular Neuroscience, University College London Hospitals NHS Foundation Trust National Hospital for Neurology and Neurosurgery, London, UK 13NIHR Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK 14MRC Centre for Neuromuscualr Diseases, National Hospital of Neurology and Neurosurgery, London, UK 15MRC Centre for Neuromuscular Diseases, UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, London, UK Acknowledgements This research was conducted with the UK Biobank resource, under application 45291 and 43383. UK Biobank was established by the Wellcome Trust, Medical Research Council, Department of Health, Scottish Government, and Northwest Regional Development Agency. UK Biobank has also had funding from the Welsh Assembly Government and the British Heart Foundation. Data collection was funded by UK Biobank.
Funding Information:
Funding MK gratefully received funding from a patient’s bequest, PhD scholarship from the Bethlehem Griffiths Research Foundation (BGRF1810-1) and an Australian Government Research Training Program (RTP) Scholarship. MPL, MMR and ASC are also supported by the National Institute for Health Research University College London Hospitals Biomedical Research. JDM is supported by a National Health and Medical Research Council (NHMRC) Early Career Fellowship (APP1161499).
Publisher Copyright:
©
PY - 2022/8
Y1 - 2022/8
N2 - Background Arterial and venous thromboembolic events (TEEs) have been associated with intravenous Ig use, but the risk has been poorly quantified. We aimed to calculate the risk of TEEs associated with exposure to intravenous Ig. Methods We included participants from UK Biobank recruited over 3 years, data extracted September 2020. The study endpoints were incidence of myocardial infarction, other acute ischaemic heart disease, stroke, pulmonary embolism and other venous embolism and thrombosis. Predictors included known TEE risk factors: age, sex, hypertension, smoking status, type 2 diabetes mellitus, hypercholesterolaemia, cancer and past history of TEE. Intravenous Ig and six other predictors were added in the sensitivity analysis. Information from participants was collected prospectively, while data from linked resources, including death, cancer, hospital admissions and primary care records were collected retrospectively and prospectively. Findings 14 794 of 502 492 individuals had an incident TEE during the study period. The rate of incident events was threefold higher in those with prior history of TEE (8.7%) than those without previous history of TEE (3.0%). In the prior TEE category, intravenous Ig exposure was independently associated with increased risk of incident TEE (OR=3.69 (95% CI 1.15 to 11.92), p=0.03) on multivariate analysis. The number needed to harm by exposure to intravenous Ig in those with a history of TEE was 5.8 (95% CI 2.3 to 88.3). Intravenous Ig exposure did not increase risk of TEE in those with no previous history of TEE. Interpretation Intravenous Ig is associated with increased risk of further TEE in individuals with prior history of an event with one further TEE for every six people exposed. In practice, this will influence how clinicians consent for and manage overall TEE risk on intravenous Ig exposure.
AB - Background Arterial and venous thromboembolic events (TEEs) have been associated with intravenous Ig use, but the risk has been poorly quantified. We aimed to calculate the risk of TEEs associated with exposure to intravenous Ig. Methods We included participants from UK Biobank recruited over 3 years, data extracted September 2020. The study endpoints were incidence of myocardial infarction, other acute ischaemic heart disease, stroke, pulmonary embolism and other venous embolism and thrombosis. Predictors included known TEE risk factors: age, sex, hypertension, smoking status, type 2 diabetes mellitus, hypercholesterolaemia, cancer and past history of TEE. Intravenous Ig and six other predictors were added in the sensitivity analysis. Information from participants was collected prospectively, while data from linked resources, including death, cancer, hospital admissions and primary care records were collected retrospectively and prospectively. Findings 14 794 of 502 492 individuals had an incident TEE during the study period. The rate of incident events was threefold higher in those with prior history of TEE (8.7%) than those without previous history of TEE (3.0%). In the prior TEE category, intravenous Ig exposure was independently associated with increased risk of incident TEE (OR=3.69 (95% CI 1.15 to 11.92), p=0.03) on multivariate analysis. The number needed to harm by exposure to intravenous Ig in those with a history of TEE was 5.8 (95% CI 2.3 to 88.3). Intravenous Ig exposure did not increase risk of TEE in those with no previous history of TEE. Interpretation Intravenous Ig is associated with increased risk of further TEE in individuals with prior history of an event with one further TEE for every six people exposed. In practice, this will influence how clinicians consent for and manage overall TEE risk on intravenous Ig exposure.
KW - CARDIOLOGY
KW - IMMUNOLOGY
KW - NEUROPATHY
KW - PHARMACOLOGY
UR - http://www.scopus.com/inward/record.url?scp=85132139941&partnerID=8YFLogxK
U2 - 10.1136/jnnp-2022-328881
DO - 10.1136/jnnp-2022-328881
M3 - Article
C2 - 35688633
AN - SCOPUS:85132139941
SN - 0022-3050
VL - 93
SP - 876
EP - 885
JO - Journal of Neurology, Neurosurgery and Psychiatry
JF - Journal of Neurology, Neurosurgery and Psychiatry
IS - 8
ER -