A Retrospective Observational Study of Adverse Reactions Associated With Intravenous Immunoglobulin Infusion

Abstract

BackgroundAlthough intravenous immunoglobulin (IVIG) therapy is generally safe and well tolerated, adverse reactions (ARs) do occur. The majority of these ARs are mild and transient. Risk factors for ARs associate with IVIG infusions are not well established. This study investigated possible risk factors influencing the occurrence of IVIG-associated ARs.Study Design and MethodsThis was a retrospective observational analysis of data accumulated over 5 years, including patient demographics, clinical condition, IVIG dosing regimens, number of IVIG infusions, and any ARs.ResultsARs were associated with IVIG in 4.9% of patients and 2.5% of infusions. By univariate analyses, ARs correlated with female sex, adult age, high dose IVIG, and autoimmune disease. Multivariate logistic regression identified three statistically significant of risk factors: on a per-patient basis, being female (p=0.0018), having neuromuscular disease (p=0.0002), and receiving higher doses of IVIG per patient body weight (p<0.001), on a per-infusion basis, being female (p < 0.001), being adolescents to middle age (p < 0.001), and having neuromuscular disease (p < 0.001).ConclusionNeuromuscular disease emerged as one of the significant factors for ARs to IVIG.

Low rates of headache and migraine associated with intravenous immunoglobulin infusion using a 15-minute rate escalation protocol in 123 patients with primary immunodeficiency

“…Despite short (15-minute) escalation increments in the infusion protocol, rates of product-related headache were not significantly different for the 5% and 10% formulations in the entire population, the adult subgroup, and the pediatric subgroup, whether calculated at the infusion level or on a per-patient basis. In contrast to our results, 10% IVIG formulations have historically been associated with increased adverse event rates compared to 5% IVIG formulations ( 2 , 6 , 11 ). Patients receiving IVIG on a 21-day schedule had higher headache rates than those receiving it on a 28-day schedule.…”

“…Rates of product-related headache were significantly higher for adults than for pediatric patients at the infusion level but not on a per-patient basis, suggesting that adults were more likely to report multiple headache events than pediatric patients. Consistent with previously published studies, rates of headache were significantly higher for adult females than adult males at the infusion level and on a per-patient basis ( 6 , 14 ). However, in the pediatric subgroup, headache rates were similar for males and females.…”

“…Intravenous immune globulin (IVIG) is a standard therapy for the treatment of primary immunodeficiency disorders ( 1 – 3 ). IVIG may be administered across a broad range of infusion rates depending on the formulation, product labeling, and patient tolerance ( 4 – 6 ). Minimizing the time required for IVIG administration may benefit patient quality of life and reduce healthcare utilization.…”

“…Headache is among the most common AEs reported with IVIG infusion, although reported rates of headache and other AEs vary considerably. Reported migraine events are more severe than other headaches but much less common and often delayed (6,(11)(12)(13)(14)(15).…”

Intravenous immunoglobulin alteration in response to adverse reactions in neurological conditions: A retrospective cohort study

“…6 Kato et al (n = 748) did, however, detect an association between AR development and being female (P = 0.0018), having neuromuscular disease (P = 0.0002) and being adolescents to middle age (P < 0.001). 12 Previously published literature has suggested that patients with neuromuscular disorders may be at an increased risk of venous thromboembolism, 10,[12][13][14] and patients with paraproteinemia may be at an increased risk of hyperviscosity effects. 15 The indication for IVIg and the presence of comorbidities were not found to be associated with the rate of AR in this study, however, this study is limited by its small sample size, which may reduce the likelihood of detecting associations.…”