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Inflammatory Bowel Diseases:
doi: 10.1002/ibd.20881
Original Article: Original Clinical Articles

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

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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.

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

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