Evaluation of Rapid vs Standard Infliximab Infusions in the Pediatric Population

Abstract

Background: Rapid 1-hour infliximab infusions have been safely implemented in adults, but studies of these rapid infusions in pediatric patients are limited. This study's primary objective was to determine the safety of 1-hour infliximab infusions compared with standard 2- to 3-hour infusions in children with inflammatory bowel disease and other autoimmune disorders.

Methods: We conducted an institutional review board-approved prospective study using an unmatched historical control group at a freestanding children's hospital comparing rapid vs standard infusion rates of infliximab and the use of premedications and immunomodulatory agents on the frequency of early and delayed infusion reactions.

Results: There were 50 subjects with 540 total standard (2- to 3-hour) infusions in the retrospective group and 66 subjects with 545 total rapid (1-hour) infusions assessed in the prospective group. Although the prospective group received a significantly higher infliximab dose, was significantly less likely to receive premedication, and was significantly more likely to receive another immunomodulatory agent, only 2 instances of potential infusion reactions occurred in the 545 rapid infusions (0.36%; 95% confidence interval [CI], 0.22%-11.01%; 3% of patients) administered in the prospective group compared with 1 documented infusion reaction (0.19%; 95% CI, 0.0%-11.47%; 2% of patients) in the retrospective group (odds ratio, 0.65; 95% CI, 0.01-12.93; P = 0.99).

Conclusions: This study suggests that rapid infusion of infliximab over 1 hour is not associated with an increased risk of infusion reactions when compared with standard 2- to 3-hour infusions and can be safely used in children with no previous reaction to standard infusions to treat inflammatory bowel disease and other autoimmune diseases.

Keywords: biologic; children; infliximab; infusion reactions; rapid infusion.