Long-Term Response Durability of Infliximab for Pediatric Inflammatory Bowel Disease in Japan: A Single Center
Naoya Tsumura1, Ken Kato1, Ryosuke Yasuda1
1Department of Pediatrics and Child Health, Kurume University School of Medicine, Kurume, Japan.
Insights
Infliximab (IFX) showed inadequate long-term durability in Japanese pediatric ulcerative colitis (UC) patients compared to Crohn's disease (CD) patients. Serious adverse events led to discontinuation in 3.6% of pediatric inflammatory bowel disease (IBD) patients.
Area of Science:
- Pediatric Gastroenterology
- Immunology
- Pharmacology
Background:
- Long-term efficacy and safety of infliximab (IFX) in pediatric inflammatory bowel disease (IBD) in Japan are not well-established.
- Understanding treatment outcomes is crucial for optimizing care in young patients.
Purpose of the Study:
- To evaluate the long-term effectiveness and safety of infliximab (IFX) treatment in Japanese children diagnosed with ulcerative colitis (UC) or Crohn's disease (CD).
Main Methods:
- Retrospective analysis of pediatric patients (<16 years) with UC or CD treated with IFX between 2011 and 2022.
- Assessment of treatment response including primary nonresponse (PNR) and secondary loss of response (sLOR).
- Evaluation of adverse events and treatment continuation rates.
Main Results:
- IFX treatment was more frequent in pediatric Crohn's disease (CD) (58.3%) than ulcerative colitis (UC) (35.1%).
- Pediatric UC patients experienced significantly higher PNR (18.5%) and sLOR (51.9%) compared to CD patients (0.0% and 21.4%, respectively).
- Long-term IFX continuation was higher in CD (71.4%) than UC (29.6%); 3.6% of patients discontinued IFX due to adverse events, including leukemia and infusion reactions.
Conclusions:
- Infliximab (IFX) demonstrated inadequate long-term durability in Japanese pediatric patients with ulcerative colitis (UC) compared to those with Crohn's disease (CD).
- Serious adverse events necessitated IFX discontinuation in a small percentage of pediatric IBD patients, highlighting the need for careful monitoring.
Purpose:
The long-term efficacy and safety of infliximab (IFX) in Japanese children with inflammatory bowel disease (IBD) remain unclear. This study aimed to examine the long-term outcomes of IFX treatment in Japanese children with IBD.
Methods:
We retrospectively recruited patients aged <16 years who were diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) at Kurume University Hospital in Japan between 2011 and 2022 and examined the effectiveness and safety of IFX. We characterized the responses to IFX as primary response, primary nonresponse (PNR), secondary loss of response (sLOR), or still receiving IFX.
Results:
Among the 77 enrolled patients with UC (median age, 10 years) and 48 with CD (median age, 12 years), 55 (27 with UC and 28 with CD) received IFX treatment. IFX treatment was significantly more common in patients with CD (58.3%) than in those with UC (35.1%; p=0.016). The PNR was significantly greater in patients with UC (18.5%) than in those with CD (0.0%; p=0.023), as was the sLOR (UC, 51.9%; CD, 21.4%; p=0.026). The likelihood of continuing IFX treatment during follow-up (median, 38 months) was significantly higher in patients with CD (71.4%) than in those with UC (29.6%; p=0.003). Adverse events resulting in the discontinuation of IFX occurred in 3.6% of the patients; one patient with CD developed leukemia, and the other had a serious infusion reaction.
Conclusion:
The long-term durability of IFX in Japanese pediatric patients with IBD was inadequate in UC compared with CD. Serious adverse events in 3.6% of patients required discontinuation.
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