Evaluation of Rapid vs Standard Infliximab Infusions in the Pediatric Population
Nicole A Rozette1, Christina M Hellauer2,3, Chephra McKee4
1Department of Pharmacy, Carilion Clinic Roanoke Memorial Hospital, Roanoke, Virginia.
Insights
Rapid 1-hour infliximab infusions are safe for children with autoimmune diseases. This study found no increased risk of infusion reactions compared to standard 2- to 3-hour infusions, supporting their use in pediatric patients.
Area of Science:
- Pediatric Rheumatology
- Gastroenterology
- Clinical Pharmacology
Background:
- Limited data exists on rapid 1-hour infliximab infusions in pediatric patients.
- Previous studies show safety in adults, but pediatric safety requires further investigation.
- Inflammatory bowel disease and autoimmune disorders are common indications for infliximab in children.
Purpose of the Study:
- To determine the safety of 1-hour infliximab infusions versus standard 2- to 3-hour infusions in pediatric patients.
- To compare the frequency of early and delayed infusion reactions between rapid and standard infliximab infusion rates.
- To assess the impact of premedications and immunomodulatory agents on infusion reactions in children.
Main Methods:
- Prospective study with a historical control group at a children's hospital.
- Compared 545 rapid (1-hour) infliximab infusions with 540 standard (2- to 3-hour) infusions.
- Monitored for early and delayed infusion reactions, noting premedication and immunomodulatory agent use.
Main Results:
- Only 2 potential infusion reactions occurred in 545 rapid infusions (0.36%) versus 1 in 540 standard infusions (0.19%).
- The rapid infusion group received higher infliximab doses and was less likely to receive premedication.
- Despite differences in adjunctive therapies, no significant increase in infusion reactions was observed with rapid infusions.
Conclusions:
- Rapid 1-hour infliximab infusions are safe and not associated with increased infusion reactions in children.
- This approach can be safely used for pediatric patients with inflammatory bowel disease and other autoimmune diseases.
- Children without prior reactions to standard infusions can benefit from shorter infusion times.
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.
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