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- Title
Comparison of endoscopic healing and durability between infliximab originator and CT-P13 in pediatric patients with inflammatory bowel disease.
- Authors
Eun Sil Kim; Sujin Choi; Byung-Ho Choe; Sowon Park; Yeoun Joo Lee; Sang Jun Sohn; Soon Chul Kim; Ki Soo Kang; Kunsong Lee; Jung Ok Shim; Yu Bin Kim; Suk Jin Hong; Yoo Min Lee; Hyun Jin Kim; So Yoon Choi; Ju Young Kim; Yoon Lee; Ji-Sook Park; Jae Young Kim; Dae Yong Yi
- 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: P=0.902, UC: P=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 (P >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 (P >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.
- Subjects
INFLAMMATORY bowel diseases; CHILD patients; CROHN'S disease; JUVENILE diseases; ULCERATIVE colitis
- Publication
Frontiers in Immunology, 2024, p01
- ISSN
1664-3224
- Publication type
Article
- DOI
10.3389/fimmu.2024.1284181