Article Text
Abstract
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.
- CARDIOLOGY
- IMMUNOLOGY
- NEUROPATHY
- PHARMACOLOGY
Data availability statement
Data may be obtained from a third party and are not publicly available. Data from the UK Biobank project were obtained from a third party, UK Biobank, on application. Interested parties can apply for data from UK Biobank directly, at http://www.ukbiobank.ac.uk.
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Data availability statement
Data may be obtained from a third party and are not publicly available. Data from the UK Biobank project were obtained from a third party, UK Biobank, on application. Interested parties can apply for data from UK Biobank directly, at http://www.ukbiobank.ac.uk.
Footnotes
Contributors ASC, MPL and MMR designed the original hypothesis and MK ran all the analyses in collaboration with IH and LJB. MK wrote the first draft of the report, apart from the model performance section and corresponding figure, which was written by IH. All authors interpreted the results, revised the text and approved the final draft of the report. MMR is responsible for the overall content as the guarantor.
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).
Competing interests MK reports Grifols sponsorship for attendance at meeting. ASC reports Grifols sponsorship for attendance at meeting and honorarium from CSL and Lupin for an advisory role. MPL was a Primary Investigator in studies for CSL Behring, UCB Pharma, Novartis, Octapharma. He has also received ad hoc consulting fees from CSL Behring, UCB and an honorarium from Terumo BCT. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Provenance and peer review Not commissioned; externally peer reviewed.
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