Change from originator infliximab to biosimilar does not affect 1‐year outcome in children with inflammatory bowel disease

Abstract

ObjectivesPayer mandates have resulted in children with inflammatory bowel disease (IBD) switching from originator Remicade® (O‐Rem) to an infliximab biosimilar (B‐IFX). Patients and families are fearful of switching because disease has been well controlled on O‐Rem. Real‐world data documenting clinical outcomes after such switches in pediatric patients are limited. The aim of this project was to examine 1 year of follow‐up in a large adolescent/young adult IBD cohort who changed from O‐Rem to B‐IFX.MethodsWe identified patients with IBD at Connecticut Children's receiving O‐Rem for at least 1 year, who were either in clinical remission or had low disease activity, and who were subsequently switched to B‐IFX. An age, gender, IBD‐subtype, and duration since diagnosis cohort that continued on O‐Rem was then matched to the switch cohort and served as a comparator group (1: switch vs. 2: no‐switch). B‐IFX was Inflectra® in all cases.ResultsTwo hundred seventy‐nine patients (mean age 18.7 years, Crohn's disease = 243, ulcerative colitis = 36) were studied (switch, n = 93, no‐switch, n = 186). Mean time since diagnosis was >6 years in both groups, and mean duration of anti‐tumor necrosis factor use was >5 years. There were no significant changes in hemoglobin, albumin, C‐reactive protein, erythrocyte sedimentation rate, or disease activity in either group over 1 year. Dosing modifications as well as the frequency of low‐level antibodies to infliximab were similar in both groups over the study period.ConclusionSwitching from O‐Rem to B‐IFX has no impact on clinical or laboratory parameters over the subsequent year. Clinicians can reliably reassure patients and families that switching is safe.