Incidence of adverse events related to intravenous immunoglobulin therapy in children.

Background: Intravenous immunoglobulin (IVIG) therapy is used in the treatment of pediatric diseases, although data about IVIG-related adverse events (IVIG-AEs) are limited. Objectives of this study were to document the incidence of IVIG-AEs in pediatric hospitalized patients and to identify risk factors for IVIG-AEs.

Methods: This retrospective cohort study included patients <18 years old who received IVIG therapy while admitted at a Canadian pediatric tertiary care center between 2016 and 2020. Patients and IVIG-perfusions characteristics were collected, as well as IVIG-AEs. Bivariate and multivariable logistic regressions were used to explore predictors of IVIG-AEs.

Results: We included 228 children, totaling 478 IVIG perfusions. Indications included treatment for inflammatory (52.6%), autoimmune disorders (35.5%), and immunoglobulin replacement (11.8%). A total of 213 IVIG-AEs were reported. Fever (13.6%) and headache (6.7%) were the most frequent IVIG-AEs. Most IVIG-AEs were mild (57%) or moderate (31%) in severity, but 12% were severe reactions. The following factors were predictive of IVIG-AEs in univariate analyses: older age (OR 1.14 [95% CI: 1.07-1.21]), dehydration (OR 2.55 [95% CI: 1.43-4.55]), concurrent allergies (OR 2.87 [95% CI: 1.26-6.56]), first perfusion (OR 1.53 [95% CI: 1.02-2.30]), and higher dosage (OR 2.14 [95% CI: 1.39-3.33]). Concurrent steroids decreased the risk of IVIG-AEs (OR 0.43 [95% CI: 0.19-0.96]). Older age and higher IVIG dose remained independent predictors of IVIG-AEs in multivariable analyses.

Conclusions: Mild IVIG-AEs are frequent in children, and serious reactions may occur. Prospective studies are needed to confirm risk factors for IVIG-AEs and to evaluate how to best prevent them.