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.

Abstract

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.

• Authors: Arie Levine, Michal Kori, Gabriel Dinari, Efrat Broide, Ron Shaoul, Baruch Yerushalmi, Avi On, Yoram Bujanover, Markus Pröls, Roland Greinwald, Israeli Pediatric Budesonide Study Group
• Journal: Inflammatory bowel diseases (Inflamm Bowel Dis) Vol. 15 Issue 7 Pg. 1055-61 (Jul 2009) ISSN: 1536-4844 [Electronic] England
• PMID: 19229988 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• Biomarkers
• Placebos
• Budesonide

Topics

• Administration, Oral
• Adolescent
• Anti-Inflammatory Agents (administration & dosage, adverse effects)
• Biomarkers
• Budesonide (administration & dosage, adverse effects)
• Child
• Crohn Disease (drug therapy, immunology)
• Dose-Response Relationship, Drug
• Female
• Follow-Up Studies
• Humans
• Male
• Placebos
• Remission Induction
• Young Adult