Efficacy of Infliximab Biosimilar for Maintenance Therapy in Pediatric Inflammatory Bowel Disease Following Infliximab Originator

Abstract

Objectives: The safety, efficacy, and cost-effectiveness of Infliximab biosimilar agents in the management of inflammatory bowel disease in adults have been shown. These agents have been recommended for pediatric inflammatory bowel disease, and although institutions are initiating therapy with the biosimilar agents (IFX-B), few are switching maintenance therapy from the originator (IFX-O). The aim was to compare biochemical markers of disease activity of children with inflammatory bowel disease on maintenance therapy with IFX-B to their previous markers on IFX-O. Methods: Single-center, retrospective chart review of 25 children with inflammatory bowel disease who transitioned from Remicade (IFX-O) to the biosimilar agent Inflectra (IFX-B) for maintenance therapy. Analysis included demographics and various biochemical markers of disease control. The nonparametric-related samples Wilcoxon signed-rank test was used to compare mean ranks of these markers (C-reactive protein, erythrocyte sedimentation rate, hemoglobin, platelet count, albumin, body mass index z score) between the last 12 months on IFX-O and the first 12 months on IFX-B. Results: Between March 2018 and June 2018, the majority of patients with pediatric inflammatory bowel disease on maintenance therapy with IFX-O at our institution were transitioned to maintenance therapy with IFX-B. Of the 25 children included, 17 were diagnosed with Crohn disease and 8 with ulcerative colitis. The results of all, except albumin value, supported retention of the null hypothesis that there would not be a statistically significant difference in the biochemical markers of disease activity between the 2 medications. Conclusions: IFX-B is as effective as IFX-O for maintenance therapy in pediatric inflammatory bowel disease when comparing biochemical markers of disease activity.