Change from originator infliximab to biosimilar does not affect 1‐year outcome in children with inflammatory bowel disease
Year: 2024
Type: article
Study design: Observational Study
Abstract: 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: = 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.
Source: JPGN Reports
DOI: 10.1002/jpr3.12134
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Genetics
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $1,900
OpenAlex ID: W4402921946