Comparison of endoscopic healing and durability between infliximab originator and CT-P13 in pediatric patients with inflammatory bowel disease

• Published in: Frontiers in immunology 2024-02, Vol.15, p.1284181-1284181
• Main Authors: Kim, Eun Sil, Choi, Sujin, Choe, Byung-Ho, Park, Sowon, Lee, Yeoun Joo, Sohn, Sang Jun, Kim, Soon Chul, Kang, Ki Soo, Lee, Kunsong, Shim, Jung Ok, Kim, Yu Bin, Hong, Suk Jin, Lee, Yoo Min, Kim, Hyun Jin, Choi, So Yoon, Kim, Ju Young, Lee, Yoon, Park, Ji-Sook, Kim, Jae Young, Yi, Dae Yong, Lee, Ji Hyuk, Choi, Kwang-Hae, Jang, Hyo-Jeong, Jeong, In Sook, Kang, Ben
• Format: Article
• Language: English
• Subjects: children; CT-P13; durability; endoscopic healing; Immunology; inflammatory bowel disease
• ISSN: 1664-3224; 1664-3224
• DOI: 10.3389/fimmu.2024.1284181

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