AI Article Synopsis

  • - The study aimed to compare the effectiveness of CT-P13, a biosimilar to the original infliximab (IFX), on endoscopic healing (EH) and drug retention in children with inflammatory bowel disease (IBD).
  • - Researchers analyzed data from 416 pediatric IBD patients, finding no significant differences in clinical outcomes or adverse effects between those receiving the IFX originator and CT-P13 at one-year follow-up.
  • - Both treatments showed similar drug retention rates, with CT-P13 slightly outperforming the IFX originator in both Crohn's disease and ulcerative colitis cases, indicating comparable therapeutic responses.

Article Abstract

Background And Aims: Favourable clinical data were published on the efficacy of CT-P13, the first biosimilar of infliximab (IFX), in pediatric inflammatory bowel disease (IBD); however, few studies have compared the effect on endoscopic healing (EH) and drug retention rate between the IFX originator and CT-P13. Therefore, we aimed to compare EH and the drug retention rate between the IFX originator and CT-P13.

Methods: Children with Crohn's disease (CD) and ulcerative colitis (UC)/IBD-unclassified (IBD-U) at 22 medical centers were enrolled, with a retrospective review conducted at 1-year and last follow-up. Clinical remission, EH and drug retention rate were evaluated.

Results: We studied 416 pediatric patients with IBD: 77.4% had CD and 22.6% had UC/IBD-U. Among them, 255 (61.3%) received the IFX originator and 161 (38.7%) received CT-P13. No statistically significant differences were found between the IFX originator and CT-P13 in terms of corticosteroid-free remission and adverse events. At 1-year follow-up, EH rates were comparable between them (CD: =0.902, UC: =0.860). The estimated cumulative cessation rates were not significantly different between the two groups. In patients with CD, the drug retention rates were 66.1% in the IFX originator and 71.6% in the CT-P13 group at the maximum follow-up period (0.05). In patients with UC, the drug retention rates were 49.8% in the IFX originator and 56.3% in the CT-P13 group at the maximum follow-up period (0.05).

Conclusions: The IFX originator and CT-P13 demonstrated comparable therapeutic response including EH, clinical remission, drug retention rate and safety in pediatric IBD.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10917915PMC
http://dx.doi.org/10.3389/fimmu.2024.1284181DOI Listing

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