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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

Levine, Arie MD1,*; Kori, Michal MD2; Dinari, Gabriel MD3; Broide, Efrat MD4; Shaoul, Ron MD5; Yerushalmi, Baruch MD6; On, Avi MD7; Bujanover, Yoram MD8; Pröls, Markus MD9; Greinwald, Roland MD9

doi: 10.1002/ibd.20881
Original Article: Original Clinical Articles

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 (

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.

© Crohn's & Colitis Foundation of America, Inc.
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