In Pediatric Patients With IBD, Switching to CT-P13 Does Not Affect PK, Immunogenicity, or Efficacy

Evidence of the safety and efficacy of biosimilar infliximab CT-P13 continues to accrue, but most data on the use of the biosimilar in inflammatory bowel disease (IBD) derives from adult patients. One recent study evaluated long-term infliximab trough levels, immunogenicity, and remission rates in children with IBD who switched from the reference infliximab to biosimilar CT-P13.

All children with Crohn disease (CD) or ulcerative colitis (UC) who were receiving maintenance infliximab at a single center (which undertook a switch from reference to infliximab for all indications) between 2017 and 2018 were included in the study.

A total of 42 patients, 26 with CD and 16 with UC, were eligible for the study. They had a median duration on infliximab of 13.5 months (range, 6.8-35.5).

No significant changes in infliximab trough level occurred after the switch; the median baseline infliximab trough level was 5.7 μg/mL (range, 3.8-9.3) versus 6.5 μg/mL (range, 3.9-8.6) 6 months after the switch to the biosimilar (P = .90). The cumulative infliximab dose administered over 6 months was not significantly different before and after the switch, and 1 patient developed new antibodies to infliximab. The proportion of patients in clinical or biological remission did not significantly change, either.

No significant changes were observed in C-reactive protein, erythrocyte sedimentation rate, albumin, weight, or body mass index after the switch, and no new safety signals were observed.

Pediatric patients who receive infliximab can be successfully switched during maintenance therapy without impacting efficacy, safety, immunogenicity, or pharmacokinetics, the authors concluded.

These are welcome data that build on the limited available knowledge about using biosimilar infliximab in children with IBD. One recent review of the literature found that, in pediatric patients who started on reference or biosimilar infliximab, remission rates were similar, and no unexpected adverse events were noted.²

The review also noted similar remission rates for children who were new starts in Polish and UK studies, and reported that in Polish and Korean switching studies, respectively, disease exacerbation was not reported, and sustained remission was similar between those who switched and those who remained on reference infliximab.

Reference

1. van Hoeve K, Dreesen E, Hoffman I, Ferrante M, Ann G, Vermeire S. Swtiching from infliximab originator to a biosimilar does not affect pharmacokinetics, immunogenicity and efficacy in pediatric patients with inflammatory bowel disease. Presented at: Digestive Disease Week 2019, San Diego, California, May 18-21, 2019. Abstract 879.

2. Sieczkowska-Golub J, Jarzebicka D, Oracz G, Kierkus J. Biosimilars in paediatric inflammatory bowel disease. World J Gastroenterol. 2018;24(35):4021-4027. doi: 10.3748/wjg.v24.i35.4021.