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

Objectives: Payer 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.

Methods: We 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.

Results: Two hundred and 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.

Conclusion: Switching 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.