The presence of high immunoglobulin A (IgA) levels in intravenous immunoglobulin (IVIG) preparations used to treat hemolytic disease of the fetus and newborn (HDFN) has been associated with the development of gastrointestinal (GI) complications, according to findings published in the Iranian Journal of Pediatrics. from a retrospective chart review conducted among infants from two centers in Istanbul and Turkey.
Currently, IVIG is regarded as a standard treatment for infants with HDFN, thus implying its effectiveness in decreasing the need for blood transfusions and improving patient outcomes. Although the therapy is typically deemed to be safe, the occurrence of rare adverse events, including life-threatening intra-abdominal perforations, has been linked to its use.
The researchers sought to explore the relationship between IgA levels in IVIG preparations and GI bleeding—that is, intra-abdominal perforation—after an IVIG infusion in newborns. The current two-center study and literature review were carried out among term newborns who had received IVIG infusion therapy between 2017 and 2020 in the neonatal intensive care unit of Marmara University or Gungoren Hospital, both of which are located in Istanbul.
The study enrolled newborns with IVIG-linked GI bleeding, necrotizing enterocolitis, and intra-abdominal perforations who had no underlying conditions other than HDFN. To be eligible for study inclusion, infants needed to have been born at ≥35 weeks’ gestational age (GA).
Read more about HDFN symptoms and risks
A total of 71 newborns were treated with IVIG therapy, with 15.5% (11 of 71) of them developing GI system complications. Overall, 36 patients were born at ≥35 weeks’ GA, with 22.2% (8 of 36) of them developing GI perforation or GI bleeding.
IgA levels of the IVIG products were compared among those who developed GI system perforation/bleeding vs those who did not develop GI symptoms. Results showed that IgA concentrations of the IVIG preparations in the GI system perforation/bleeding arm were statistically significantly higher than those in the study arm without any GI complications (P =.024).
Based on a receiver operating characteristic (ROC) analysis of IgA levels and major GI system issues, the cut-points of 5 mg/dL and 14 mg/dL were associated with statistically significant thresholds with an acceptable area under the curve (AUC) of 0.762, along with sensitivity and negative predictive values that were both 100%.
“The use of IVIG therapy should be carefully considered, and the choice of IVIG preparation with low IgA content might be beneficial in reducing the risk [for] adverse [GI] effects,” the authors emphasized. “Further extensive and prospective studies are necessary to identify risk factors and optimize the use of IVIG therapy in neonates with [HDFN] and other conditions.“
The authors concluded, “It is also essential to inform parents and their families of the potential risks and benefits of this treatment so that they can make informed decisions about their care.”
