Rapid Rate Intravenous Immunoglobulin Administration: Safety Outcomes in 11,334 Infusions

Abstract

A national home infusion services provider (KabaFusion, LLC) traditionally administered intravenous immunoglobulin (IVIG) at conservative maximum infusion rates to minimize adverse drug reactions (ADRs).  The objective of this retrospective observational study was to identify the impact of increased on-label infusion rates of a specific, high-purity product (Octagam) on patient safety. The study included all patients who received IVIG over a 10-year period. The study population was composed of both adult and pediatric patients, with neuroimmune, neuromuscular disorders, and primary immune deficiency diseases warranting IVIG treatment.  Patients were divided into two randomized groups to provide an even distribution for analysis: those who received IVIG infusions at a rate of <110 mL/hr (Group 1) and those who received IVIG at ³110 mL/hr (Group 2). There were 489 patients identified for inclusion in Group 1 (n=245) and Group 2 (n=244). Demographics (gender, age) and exposure (number of infusions) were similar between both groups.

The study data included 11,334 total IVIG infusions with a total of 392 ADRs (3.5%). ADRs in the high infusion rate group (Group 2) were significantly lower (5.1% vs.1.8%, p<0.0001). In addition, the incidence of non-serious ADRs in Group 2 (1.7%) vs. Group 1 (4.8%) were also significantly lower in the high infusion rate group (p<0.0001). The number of serious adverse drug reactions (SADRs) was lower in Group 2 but did not reach statistical significance (Group 1: 0.3% vs Group 2:0.1%, p=0.0741). Based on these results, infusion rates of specific high-purity IVIG products were associated with statistically and clinically significant lower non serious ADRs in both the adult and pediatric populations, in addition to having an association of clinical significance in both for SADRs.  These results can be of great utility in clinical application if applied within the manufacturer’s recommended guidelines, to ease the burden of time required for patients undergoing IVIG infusions.