Week 14 Infliximab Level Provides Modest Benefit to Clinical Outcomes in Children with Crohn's Disease
Asha Jois1, Rachel Horn1, Anysha Walia1
1Department of Gastroenterology and Clinical Nutrition, Royal Children's Hospital, Parkville, VIC, Australia.
Insights
Determining infliximab (IFX) drug levels early in children with Crohn's disease showed no significant difference in treatment failure rates. However, a proactive approach may offer minor benefits in biochemical markers like C-reactive protein.
Area of Science:
- Pediatric Gastroenterology
- Immunology
- Pharmacology
Background:
- Crohn's disease management in children requires effective therapeutic strategies.
- Infliximab (IFX) is a key biologic therapy for pediatric Crohn's disease.
- The optimal timing and utility of therapeutic drug monitoring (TDM) for IFX in this population remain under investigation.
Purpose of the Study:
- To compare 6- and 12-month outcomes in pediatric Crohn's disease patients commencing IFX.
- To evaluate the impact of determining IFX drug levels at week 14 (W14 group) versus not (NoW14 group).
- To assess differences in clinical and biochemical disease activity, IFX persistence, and failure rates.
Main Methods:
- Retrospective, single-center study of 83 children (0-18 years) with Crohn's disease receiving IFX induction (2018-2021).
- Patients were divided into W14 (IFX level determined at week 14) and NoW14 groups.
- Outcomes including disease activity, IFX levels, dose, frequency, and failure (biologic switch, corticosteroid use, hospitalization, surgery) were compared at 6 and 12 months.
Main Results:
- No significant difference in 12-month failure rates (33% vs. 33%) or IFX persistence (98% vs. 95%) between W14 and NoW14 groups.
- No difference in IFX drug levels at 6 or 12 months between the groups.
- The W14 group showed a greater reduction in C-reactive protein and increase in albumin at 12 months.
Conclusions:
- Knowledge of week 14 infliximab levels, without defined response thresholds, offers limited benefit for children with Crohn's disease.
- Proactive TDM may have a minor positive impact on biochemical markers of inflammation.
- Further research is needed to define optimal TDM strategies in pediatric IBD.
Purpose:
Benefits of a proactive compared to a reactive therapeutic drug monitoring strategy when commencing infliximab (IFX) in children with Crohn's disease are unclear. We evaluated the 6- and 12-month outcomes in children commencing IFX with a week 14 level (W14) determined compared to without (NoW14).
Methods:
Single-centre, retrospective study of children with Crohn's disease aged 0-18 years with a primary response to IFX induction between 2018-2021. W14 group had a week 14 IFX drug level determined and NoW14 group did not. Baseline patient, medication and disease characteristics were compared across the two groups. Clinical and biochemical disease activity measures, and IFX dose, frequency and drug level were compared at week 0, 6- and 12-months post-induction. Failure was defined by biologic switch, corticosteroid use, hospitalisation or surgery.
Results:
We included 83 children diagnosed at median 13 years, with a median disease duration of 5 years. The W14 group (40/83, 48.2%) had a higher C-reactive protein (CRP) than NoW14 group. At 12-months, there was no difference in failure rates (33% vs. 33%, p=0.50) or IFX persistence (98% vs. 95%, p>0.999) between the W14 and NoW14 groups, respectively. There was no difference in IFX drug level at 6- or 12-months. At 12-months, there was a greater reduction in CRP and rise in albumin in the W14 group.
Conclusion:
Knowledge of a week 14 level without strict thresholds on how and when to respond may be of minor benefit for children commencing infliximab for Crohn's disease.
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