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Long-Term Durability of Infliximab for Pediatric Ulcerative Colitis: A Retrospective Data Review in a Tertiary
Hirotaka Shimizu1,2, Katsuhiro Arai1, Ichiro Takeuchi1,2
1Center for Pediatric Inflammatory Bowel Disease, Division of Gastroenterology, National Center for Child Health and Development, Tokyo, Japan.
Insights
Infliximab (IFX) shows effectiveness in pediatric ulcerative colitis (UC), but long-term treatment success is limited. Many children discontinue IFX due to nonresponse, loss of response, or side effects, highlighting the need for careful patient selection and monitoring.
Area of Science:
- Pediatric Gastroenterology
- Immunology
- Pharmacology
Background:
- Long-term efficacy and safety of infliximab (IFX) in pediatric ulcerative colitis (UC) require further evaluation.
- Understanding IFX durability is crucial for managing this chronic condition in children.
Purpose of the Study:
- To assess the long-term efficacy, safety, and durability of infliximab (IFX) in a pediatric cohort with ulcerative colitis (UC).
Main Methods:
- Retrospective analysis of 20 children with UC treated with infliximab (IFX).
- IFX administered for induction (weeks 0, 2, 6) and maintenance (every 8 weeks), with dose adjustments based on clinical decisions.
Main Results:
- Corticosteroid (CS)-free remission without dose escalation (DE) achieved in 30% at week 30 and 25% at week 54.
- Patients achieving remission at week 30 sustained colectomy-free IFX treatment.
- One-third discontinued IFX due to primary nonresponse, one-third due to secondary loss of response (sLOR).
- Higher IFX durability observed with concurrent azathioprine use for over 6 months.
- Infusion reactions (IRs) occurred in 10 patients, leading to discontinuation in four.
- Psoriasis-like lesions developed in three patients; one experienced acute focal bacterial nephritis.
Conclusions:
- Infliximab (IFX) is a relatively safe and effective option for pediatric ulcerative colitis (UC).
- Achieving clinical remission by week 30 predicts long-term, colectomy-free IFX treatment.
- Approximately two-thirds of patients faced challenges with IFX therapy, including nonresponse, sLOR, infusion reactions, and side effects.
Purpose:
The long-term efficacy and safety of infliximab (IFX) in children with ulcerative colitis (UC) have not been well-evaluated. Here, we reviewed the long-term durability and safety of IFX in our single center pediatric cohort with UC.
Methods:
This retrospective study included 20 children with UC who were administered IFX.
Results:
For induction, 5 mg/kg IFX was administered at weeks 0, 2, and 6, followed by every 8 weeks for maintenance. The dose and interval of IFX were adjusted depending on clinical decisions. Corticosteroid (CS)-free remission without dose escalation (DE) occurred in 30% and 25% of patients at weeks 30 and 54, respectively. Patients who achieved CS-free remission without DE at week 30 sustained long-term IFX treatment without colectomy. However, one-third of the patients discontinued IFX treatment because of a primary nonresponse, and one-third experienced secondary loss of response (sLOR). IFX durability was higher in patients administered IFX plus azathioprine for >6 months. Four of five patients with very early onset UC had a primary nonresponse. Infusion reactions (IRs) occurred in 10 patients, resulting in discontinuation of IFX in four of these patients. No severe opportunistic infections occurred, except in one patient who developed acute focal bacterial nephritis. Three patients developed psoriasis-like lesions.
Conclusion:
IFX is relatively safe and effective for children with UC. Clinical remission at week 30 was associated with long-term durability of colectomy-free IFX treatment. However, approximately two-thirds of the patients were unable to continue IFX therapy because of primary nonresponse, sLOR, IRs, and other side effects.
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