Abstract
BackgroundBoth intravenous and subcutaneous human immune globin G (IgG) replacement (IVIG and SCIG, respectively) reduce severe infection and increase serum IgG levels in primary immune deficiency disorder (PIDD) patients who require replacement. SCIG can be administered either with the aid of an infusion pump, or by patients or caregivers themselves, using butterfly needles and a syringe (“SCIG push”). SCIG offers advantages over IVIG, including higher steady state IgG levels, improved patient quality of life indicators, and decreased cost to the healthcare system, and for these reasons, SCIG has been increasingly used in Manitoba starting in 2007. We sought to determine the effectiveness of SCIG push in our local adult PIDD population.MethodsWe conducted a retrospective chart review of all adult patients enrolled in the SCIG push program in Manitoba, Canada from its inception in November 2007 through September 2018. We included patients who were naïve to IgG replacement prior to SCIG, and those who had received IVIG immediately prior. We collected data regarding serum IgG levels, antibiotic prescriptions, hospital admissions, and adverse events during a pre-defined period prior to and following SCIG initiation. Statistical significance was determined via two-tailed t-test.Results62 patients met inclusion criteria, of whom 35 were on IVIG prior and 27 were IgG replacement naïve. SCIG push resulted in an increase in serum IgG levels in those naïve to IgG replacement, as well as in those who received IVIG prior. SCIG push also resulted in a statistically significant reduction in number of antibiotic prescriptions filled in the naïve subgroup, and no significant change in antibiotics filled in the IVIG prior group. 8/62 PIDD patients (12.9%) left the SCIG program during our review period for varying reasons, including side-effects.ConclusionsIn a real-life setting, in the Manitoba adult PIDD population, SCIG push is an effective method of preventing severe infections, with most patients preferring to continue this therapy once initiated.
Highlights
Both intravenous and subcutaneous human immune globin G (IgG) replacement (IVIG and Subcutaneous immune globulin (SCIG), respectively) reduce severe infection and increase serum IgG levels in primary immune deficiency disorder (PIDD) patients who require replacement
IgG administration via SCIG push provided an adequate steady-state IgG, and resulted in a statistically significant reduction in antibiotic prescriptions filled in the IgG replacement naïve population (Table 2, Fig. 2)
SCIG push patients who were naïve to replacement had a reduction in antibiotic prescriptions after treatment compared to before treatment, and those who were on Intravenous immune globulin (IVIG) prior had no increase in the rate of antibiotic prescription on SCIG, suggesting that SCIG replacement was no less effective compared to IVIG
Summary
Both intravenous and subcutaneous human immune globin G (IgG) replacement (IVIG and SCIG, respectively) reduce severe infection and increase serum IgG levels in primary immune deficiency disorder (PIDD) patients who require replacement. Initial FDA recommendations were to use a higher dose SCIG regimen when compared to IVIG to obtain these levels, newer data shows that target serum IgG concentrations can typically be obtained with a 1:1 SCIG:IVIG dosing ratio This is based on IgG trough data showing that infectious complications are better prevented when SCIG is dosed by this method, rather than the area-under-the-curve pharmacokinetics used by the FDA in their recommendations [9]. This is of clinical and economic importance as it indicates SCIG replacement does not require an excess of biologic product when compared to IVIG. SCIG has been used increasingly, with some data showing increased IgG levels [1,2,3], improved patient quality of life indicators [2, 10,11,12,13], and decreased overall cost to the healthcare system when compared to IVIG [1,2,3,4,5, 10, 12, 14]
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