IVIg-exposure and thromboembolic event risk: cohort study using the UK Biobank

Abstract

Objectives Arterial and venous thromboembolic events (TEEs) have been associated with intravenous immunoglobulin (IVIg) use, but the risk has been poorly quantified. We aimed to calculate the risk of TEEs associated with IVIg exposure.

Methods We included participants from UK Biobank. Study endpoints: incidence of myocardial infarction, other acute ischemic heart disease, stroke, pulmonary embolism, other venous embolism, and thrombosis. Predictors included known TEE risk factors: age, sex, hypertension, smoking status, type 2 diabetes mellitus, hypercholesterolemia, cancer, and history of TEE (phx). IVIg was added in the sensitivity analysis.

Results 14 794 of 502 543 individuals had an incident TEE during the study period. In the phx category, IVIg exposure was independently associated with increased risk of incident TEE (OR= 3·69, p=0·03) on multivariate analysis. The number needed to harm in phx group was 5·8 (95% CI, 2·3–88·3).

IVIg exposure did not increase risk of TEE in those without phx. If everyone in the phx group was exposed to IVIg, the median risk of recurrent event in those <60 years of age increases from 6.1% to 19.3% and in those >60 from 9.1% to 26.9% (moving nearly 50% of individuals into >20% risk of recurrent TEE). A similar change in risk was seen if the cohort was divided by gender.

Conclusion IVIg is associated with increased risk of further TEE in individuals with phx. In practice, this will influence how clinicians consent for and manage overall TEE risk upon IVIg exposure in high-risk patients. Show more