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.
1Pediatric Gastroenterology Unit, Wolfson Medical Center and Sackler School of Medicine, Tel Aviv University, Israel
2the Pediatric Gastroenterology Units of the Kaplan Medical Center, Israel
3Schneider Childrens Hospital, Israel
4Asaf Harofe Hospital, Israel
5Bnei Zion Medical Center, Israel
6Soroka Medical Center, Israel
7Poriah Medical Center, Israel
8Safra Childrens Hospital, Israel
9Dr. Falk Pharma, Freiberg, Germany
*Reprints: Pediatric Gastroenterology Unit, Wolfson Medical Center, POB 5 Holon, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
Received 29 October 2008; Accepted 20 December 2008
Published online 19 February 2009 in Wiley InterScience (www.interscience.wiley.com).
Grant sponsor: Dr. Falk Pharma.
The study was conceived and designed by Dr. Levine and funded by Dr. Falk Pharma; Dr. Levine wrote the article. Dr. Levine did not receive any personal funding, honorarium, or any other direct funding. Funds for designing and enrolling patients were paid to the research and clinical institutions involved and not directly to Dr. Levine.