AUTHOR=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 TITLE=Comparison of endoscopic healing and durability between infliximab originator and CT-P13 in pediatric patients with inflammatory bowel disease JOURNAL=Frontiers in Immunology VOLUME=15 YEAR=2024 URL=https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1284181 DOI=10.3389/fimmu.2024.1284181 ISSN=1664-3224 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.