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

Arie Levine, Michal Kori, Gabriel Dinari, Effat Broide, Ron Shaoul, Baruch Yerushalmi, Avi On, Yoram Bujanover, Markus Pröls, Roland Greinwald, Esther Granot, Zvi Weizman, Aaron Lerner, Avi Pacht, Ayala Yaron, Shimon Reif, David Wald, Arie Silbermintz

    Research output: Contribution to journalArticlepeer-review

    29 Scopus citations

    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.

    Original languageEnglish
    Pages (from-to)1055-1061
    Number of pages7
    JournalInflammatory Bowel Diseases
    Volume15
    Issue number7
    DOIs
    StatePublished - 1 Jan 2009

    Keywords

    • Budesonide
    • Child
    • Colitis
    • Crohn's disease
    • Inflammatory bowel disease
    • Pediatric

    ASJC Scopus subject areas

    • Immunology and Allergy
    • Gastroenterology

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