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Controlled ileal release budesonide in pediatric Crohn disease: efficacy and effect on growth
P Kundhal1, M Zachos, J L Holmes
1Division of Pediatric Gastroenterology and Nutrition, Hospital for Sick Children, University of Toronto, 555 University Avenue, Toronto, M5G 1X8, Ontario, Canada.
Insights
Controlled ileal release (CIR) budesonide showed modest effectiveness for pediatric Crohn disease but raised concerns about subnormal linear growth. Further pediatric trials are needed to assess growth parameters alongside treatment efficacy.
Area of Science:
- Pediatric Gastroenterology
- Inflammatory Bowel Disease Research
- Pharmacological Studies in Children
Background:
- Limited data exist on controlled ileal release (CIR) budesonide's effect on linear growth in pediatric patients.
- Adult study outcomes for CIR budesonide effectiveness are available, but pediatric-specific growth data are lacking.
- This study reviews outcomes, focusing on linear growth, in children and adolescents treated with CIR budesonide for active intestinal inflammation and remission maintenance.
Purpose of the Study:
- To evaluate the effectiveness of CIR budesonide in children and adolescents with active Crohn disease.
- To assess the impact of CIR budesonide therapy on linear growth in pediatric patients.
- To provide evidence for future randomized controlled pediatric trials regarding growth parameters.
Main Methods:
- A retrospective review of 32 children (mean age 14.1 years) with Crohn disease of the distal ileum treated with 9 mg daily CIR budesonide.
- Assessment of disease activity using the Pediatric Crohn Disease Activity Index (PCDAI) at baseline and follow-up.
- Monitoring of linear growth, specifically height velocity, in prepubertal responders on long-term therapy.
Main Results:
- 59% of patients showed a physician-judged response to CIR budesonide.
- PCDAI scores significantly decreased from 33 to 22 (P = 0.001) in a subset of patients.
- 29% of patients achieved remission (PCDAI < 15).
- Prepubertal responders on 6 mg CIR budesonide for 6-13 months exhibited subnormal mean height velocity (2.3 cm/year), with none exceeding 4 cm/year.
Conclusions:
- CIR budesonide demonstrates modest effectiveness for active ileal Crohn disease in children, supported by Grade III evidence.
- Subnormal linear growth observed during CIR budesonide therapy is a significant concern, potentially due to uncontrolled inflammation or direct growth suppression.
- Future randomized controlled pediatric trials must incorporate linear growth as a primary outcome variable to fully understand CIR budesonide's impact.
Background:
Although the effectiveness of controlled ileal release (CIR) budesonide in children can be extrapolated from adult studies, there are currently no data available concerning the effects of CIR budesonide therapy on linear growth. In the absence of controlled, prospective pediatric clinical trials, we reviewed the outcomes, particularly linear growth, of children and adolescents given CIR budesonide to treat active intestinal inflammation and to maintain remission.
Methods:
Thirty-two children (20 males) aged 14.1 +/- 2.7 years with Crohn disease of the distal ileum with or without right colon involvement were treated for active Crohn disease (baseline Pediatric Crohn Disease Activity Index, 34 +/- 14) with 9 mg daily of CIR budesonide through the Hospital for Sick Children, University of Toronto, Inflammatory Bowel Diseases program.
Results:
At first follow-up visit 8.7 +/- 6.0 weeks later, 19 of 32 (59%) were judged by the physician to have responded. In the subset of 22 patients who had laboratory tests repeated at the first follow-up visit, their Pediatric Crohn Disease Activity Index fell from 33 +/- 14 to 22 +/- 16 (P = 0.001). The Pediatric Crohn Disease Activity Index score fell to less than 15 (cut-off score remission) in 29%. Six prepubertal responders continued to receive 6 mg CIR budesonide for 6 to 13 months. Five of the 6 experienced only mild or no gastrointestinal symptoms and gained weight. Nevertheless, their mean height velocity was only 2.3 +/- 1.0 cm/year, and none grew at a rate of more than 4cm/year whilst receiving CIR budesonide.
Conclusions:
These data provide grade III evidence of modest effectiveness of CIR budesonide in children with active Crohn disease confined to the ileum with or without right colon involvement. The subnormal growth observed with continued therapy is concerning and may reflect either inadequately controlled intestinal inflammation or direct suppression of linear growth, as is observed with conventional corticosteroids. Randomized controlled pediatric trials of CIR budesonide must include parameters of linear growth as an outcome variable.