Infliximab Biosimilars in Pediatric Inflammatory Bowel Disease: Comparison and Adverse Effects

Background:
Patients with inflammatory bowel disease (IBD) often require treatment with infliximab (TNF alpha inhibitor) infusion. This biological treatment has a high efficacy, and patients respond well to it. However, the cost of the biologic treatment has increased, and insurance companies are becoming increasingly hesitant to approve infliximab and are instead favoring biosimilars. Biosimilars (biologicals that are highly similar but not identical to the reference drugs) are affordable alternatives and many patients are now being initiated with biosimilars or patients are transitioning from infliximab to infliximab biosimilars. Studies have shown the efficacy and safety of biosimilar treatment are similar to that of infliximab in both adult and pediatric patients but with limited research in pediatric patient populations. The increasing use of biosimilars in hospitals and infusion centers warrants further research into tolerability of the treatment. This study aims to compare the acute adverse effects (AEs) of infliximab infusions with infliximab biosimilar infusions in the pediatric population with IBD.
Methods:
A retrospective chart review was conducted on the potential acute AEs experienced by patients receiving either infliximab infusions or 1 of 3 infliximab biosimilar infusions: infliximab-dyyb, infliximab-abda, or infliximab-axxq. Data was collected from 70 patients in our hospital-based infusion center. 32 patients were initiated and maintained on infliximab. 26 patients were initiated and maintained on a biosimilars of infliximab. 12 patients were initiated on infliximab then switched to a biosimilar. Patients were between the ages of 6-22 and had diagnoses of Crohn’s Disease or ulcerative colitis. All patients were premedicated with acetaminophen and diphenhydramine. All acute adverse infusion reactions experienced between 1/1/2019 and 3/28/2024 were noted.
Results:
26 patients received 328 infliximab biosimilar infusions and 43 patients received 979 infliximab infusions. 2 acute infusion reactions were reported in patients receiving infliximab biosimilar infusions and 4 acute infusions were reported in patients receiving infliximab infusions. AEs experienced secondary to infliximab biosimilar infusions consisted of tachycardia and flushing. AEs experienced secondary to infliximab infusions included tachycardia, dizziness, bradycardia, and hypotension. No AEs were recorded for patients who switched from infliximab to a biosimilar.
Conclusions:
Infusions of infliximab biosimilars were not associated with an increase of acute infusion reactions compared with infliximab infusions indicating that biosimilar infusions are well-tolerated and safe to use for treatment of IBD in pediatric patients. No adverse events were noted when interchanging between Infliximab and Infliximab Biosimilar.