Retrospective Cohort Analysis of 1-Hour Infliximab Infusions in Pediatric Patients.

Abstract

Objective: This study aimed to characterize and assess the safety of a 1-hour infliximab infusion in a cohort of pediatric patients.

Methods: A retrospective chart review of pediatric patients that received a 1-hour infliximab or its biosimilar infusion for a gastrointestinal or rheumatologic condition was conducted. Infusions were included if the patient had at least 3 infusions for rheumatology patients and 4 for gastroenterology patients. Patients who were not transitioned to the rapid, 1-hour infusion were excluded. Baseline characteristics, including age, weight, indication, dose, the use of premedications or combination therapy, and the development of anti-infliximab antibodies were analyzed along with any reported safety outcomes related to infusion administration.

Results: A total of 69 pediatric patients were screened for inclusion, of which 41 patients received 159 infusions. The median age of the population was 15 years, and the sex distribution was nearly equal, with 48.8% of the population representing females. Most patients received infliximab treatment by the pediatric gastroenterology service (87.8%), with Crohn's disease being the lead indication (75.6%). A small number of patients were managed with combination therapy or premedicated before their infusion. Forty-one patients were routinely monitored for infliximab antibodies, but only 4 developed them (9.8%). Doses ranged from 150 to 1000 mg, depending on patient weight. One patient (0.6%) experienced an adverse reaction during the 1-hour infusion, which resulted in cessation of the infusion, but continued 1-hour infusions at a later date.

Conclusions: This study showcases that 1-hour infliximab infusions are well-tolerated and appear safe in pediatric patients.