Introduction: Immunoglobulin administration is a mainstay in Inborn Errors of Immunity (IEI) with humoral defects. The FDA approved conventional subcutaneous immunoglobulin (SCIg) in 2006. It has been used in Argentina since 2010. This study reports the results of 12 years of this treatment. Method: Retrospective study (September 2010 – September 2022).71 medical records manually reviewed. 58 patients (p) were included and 13p excluded (did not meet inclusion criteria). Study outcomes: 1. Efficacy based on: severe infections, need for hospital admission and IgG serum levels at 6 months; 2. Safety and Tolerability based on: adverse events (AEs) classified as local or systemic. Data were analyzed using descriptive statistics and percentages for qualitative variables.
Results: Study population: 58p (2 – 85 years). 55.17% females, 44.82% males. 72.40% had humoral immunity involvement. All patients were followed for at least one year, and 52.63% for more than 5.
Treatment information: 16p (27.58%) were naïve of treatment. Mean age of SCIg initiation: 22.57 years. 87.71% received replacement (=1gr/kg/dose). 56.14% received weekly infusion, 8.77% every 10 days and 31.57% every 15 days. Two infusion sites in 77.19%.
Efficacy: 59.64% presented new infections (mostly upper or low respiratory) after SCIg. 13p (22.41%) needed hospitalization, no one in intensive care unit. Significant increase in serum IgG (>900mg/dl) after 6 months of treatment, from 36.20% to 68.96%. Safety and Tolerability: 10p (17.24%) presented AEs, all of them locally. Of the 58p: 33p (56.89%) chose to continue with SCIg. 25p suspended treatment due to: 8p (13.79%) medical indication, 4p (6.89%) patient decision, 3p (5.17%) switched to facilitated SCIg, 9p (15.51%) suspended follow-ups and 1p (1.72%) died because of his underlying disease. Conclusions:
-Patients receiving SCIg may present infections, but these were not severe.
-SCIg is a useful treatment, safe and well tolerated in IEI patients.