16. Pediatric Patient Considerations for First Dose of Subcutaneous Immunoglobulin Therapy in the Home

Background: According to literature, parents of pediatric patients prefer intravenous immunoglobulin (IVIG) therapy due to reduced administration frequency and lower injection-related fears (Lechanska‐Helman et al., 2020). However, IVIG therapy can significantly impact school or work attendance. As an alternative, subcutaneous immunoglobulin (SCIg) therapy has demonstrated a low incidence of adverse events, making it a safe option for home treatment (Gupta et al., 2023).

The incidence of adverse reactions in SCIg therapy varies depending on individual factors and the specific therapy. Studies have shown that adverse reactions are generally mild and infrequent, with local reactions such as redness, swelling, or itching at the injection site being the most common (Immunoglobulin National Society [IgNS], 2024). Less common adverse reactions include headache, fatigue, and fever.

The initiation of SCIg therapy in pediatric patients at home is often associated with concerns related to safety of the first dose, potential risk for severe adverse reactions, parental fear and resistance, and availability of competency nurses to care for this patient population. The hypothesis for this study is that SCIg therapy may be safely administered as a first dose with consistent evaluation, communication, training, and safety parameters in place (IgNS, 2024).

Purpose: The purpose of this abstract is to present findings from a retrospective data analysis investigating the safety and feasibility of administering the first dose of subcutaneous immunoglobulin (SCIg) therapy in pediatric patients at home.

Methods: Electronic medical records for starts of care of 52 patients from 1/1/2020 to 5/15/24 were analyzed for dispensing data and nursing documentation. Inclusion criteria was patients between 1 month and 12 years of age at the time of the first subcutaneous immunoglobulin therapy dispense were included for analysis. Descriptive statistics were utilized to identify percentages and trends.

Results: A first dose was administered to 42 participants. Retrospective analysis of the data indicated that the adverse reactions to SCIg were mostly mild (17 cases) or moderate (10 cases), with no reports of severe reactions. These data suggest that the adverse reactions reported in this population are similar or better than previously reported evidence for adolescent and adult patients on SCIg therapy (Anderson-Smits et al., 2022). Infusion nursing services were provided by Optum (33) as well as outsourced (19) where it was noted there was an increased incidence of localized adverse drug reactions in the Primary Immunodeficiency population (Agency 47.3%; Optum 42.3).

Discussion: While the incidence of adverse reactions was generally mild or moderate, concerns related to the safety of the first dose, parental fear and resistance, and nursing competence and comfort in providing therapy to this patient population remain. This presents an opportunity to improve patient outcomes and satisfaction by implementing a shared decision-making process that educates parents on the risks associated with SCIg therapy and sets clear expectations for administration.

Conclusions: This analysis provides important insights into the safety of SCIg therapy for pediatric patients. While adverse reactions were generally mild or moderate, concerns related to the safety of the first dose, parental fear and resistance, and internal and outsourced nursing competency and comfort in providing therapy to this patient population remain. However, by implementing a shared decision-making process, considering geography and home appropriateness, providing nurse training and clinician oversight, organizations can improve patient outcomes and satisfaction when initiating SCIg therapy in pediatric patients.