Rapid Versus Standard Infliximab and Infliximab Biosimilar Infusions in Pediatric Inflammatory Bowel Disease: Comparison of Adverse Reactions

Background:
Infliximab is an anti-tumor necrosis factor which is used to treat IBD. Infliximab Biosimilars are increasingly used due to their cost effectiveness and equal efficacy. Patients start with standard infusion rate and then transition to rapid infusions if standard infusions are tolerated. Rapid infusion protocol at our hospital based infusion center is to initiate infusion at 100 mL/hour for 15 minutes then increase to 300 mL/hour for the remainder of the infusions. Acetaminophen and diphenhydramine are given to all patients prior to each infusion. Rapid infusions of infliximab (shortening from 120 to 60 min) has been shown to be safe and cost effective in several studies. However, there is limited data in regard to safety of rapid infusions of Biosimilar Infliximab in children. More research is warranted on the adverse effects of rapid infliximab biosimilar infusions given the increasing trend of biosimilar use to treat IBD. The aim of this study is to compare the acute adverse effects of rapid infliximab and biosimilar infusions with standard infliximab and biosimilar infusions in the pediatric population with IBD.
Methods:
A retrospective chart review was conducted on the adverse events (AEs) of rapid infusions (75 minutes) and standard infusions (135 minutes) in our hospital-based infusion center between 1/1/2019 and 3/28/2024. Infusion reactions were defined as anaphylaxis, shortness of breath, hypertension, hypotension, swelling, chest pain, rash, flushing, chills, headaches, fevers, tachycardia, and bradycardia. 29 females and 41 males between the ages of 6-22 had diagnoses of Crohn’s disease or ulcerative colitis. Infusions were of infliximab or infliximab biosimilars. Data was collected from 70 patients. 44 received standard infusions and 33 received rapid infusions. Of the 33 rapid infusion patients, 14 received infliximab infusions and 19 received biosimilar infusions, 7 of which had previously switched from infliximab to a biosimilar for nonmedical reasons. Of the standard infusion patients, 25 received infliximab infusions, 15 received biosimilar infusions, and 4 received both infliximab and biosimilar infusions. An average of 20 infliximab standard infusions and 7 biosimilar standard infusions were received before initiating rapid infusions.
Results:
83 rapid infliximab biosimilar infusions and 70 rapid infliximab infusions were administered. 257 standard infliximab biosimilar infusions and 629 standard infliximab infusions were administered. Overall, 6 acute infusion reactions were reported, 5 rapid and 1 standard. Out of the 5 rapid infusion reactions, 2 were biosimilar infusions and 3 were infliximab infusions. One patient accounted for 1 rapid infliximab adverse effect and 1 standard infliximab adverse effect. Overall, 17% (1/6) of AEs were due to rapid biosimilar infusions, 33% (2/6) to standard biosimilar infusions, 50% (3/6) to standard infliximab infusions, and 0% (0/6) were due to rapid biosimilar infusions.
Conclusions:
Neither rapid infliximab nor rapid biosimilar infusions were associated with an increase of acute infusion reactions when compared with standard infliximab and standard biosimilar infusions indicating that rapid infusions of both infliximab and biosimilar infusions are well-tolerated and safe to use for treatment of IBD in pediatric patients.