Comparison of two dosing methods for induction of response and remission with oral budesonide in active pediatric Crohn's disease: A randomized placebo-controlled trial
✍ Scribed by Arie Levine; Michal Kori; Gabriel Dinari; Efrat Broide; Ron Shaoul; Baruch Yerushalmi; Avi On; Yoram Bujanover; Markus Pröls; Roland Greinwald
- Publisher
- John Wiley and Sons
- Year
- 2009
- Tongue
- English
- Weight
- 109 KB
- Volume
- 15
- Category
- Article
- ISSN
- 1078-0998
No coin nor oath required. For personal study only.
✦ Synopsis
Background:
Oral budesonide has been found to be comparable to systemic corticosteroids in mild to moderately active crohn's disease (cd). remission rates in pediatric studies to date have been suboptimal (47%-55%), even though patients with colonic involvement were excluded in some studies. in addition, the optimal pediatric dosing regimen has never been evaluated before.
Methods:
This was a randomized, controlled, double-blind study in 70 children with mild or moderately active cd randomized to 1 of 2 groups: group 1: standard dose budesonide (9 mg/day) for 7 weeks followed by 6 mg budesonide daily for an additional 3 weeks. group 2: induction with 12 mg/day for the first month followed by the same regimen as group 1. outcome measures included a decrease in pediatric crohn's disease activity index and remission rates. patients with colonic disease were not excluded.
Results:
At week 7 a clinical response was obtained in 51.4% in group 1 versus 74.3% in group 2. a significant decrease in c-reactive protein was seen only in group 2. at the end of treatment, remission was obtained in 42.9% in group 1 versus 65.7% in group 2 (p = 0.054). there was no significant difference in adverse events or serum cortisol.
Conclusions:
Use of an induction dose of budesonide followed by a budesonide taper resulted in a trend to higher rates of clinical remission and a decrease in inflammation, without an increase in steroid-associated side effects. budesonide was also useful for patients with ileocolonic disease.