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.
RCT Entities:
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: Peter C Church; Mary-Louise C Greer; Ruth Cytter-Kuint; Andrea S Doria; Anne M Griffiths; Dan Turner; Thomas D Walters; Brian M Feldman Journal: Pediatr Radiol Date: 2017-03-10
Authors: Y A Masannat; A Agrawal; L Maraqa; M Fuller; S K Down; Ssk Tang; D Pang; M Kontos; L Romics; S D Heys Journal: Ann R Coll Surg Engl Date: 2019-09-06 Impact factor: 1.891
Authors: M Ellen Kuenzig; Ali Rezaie; Cynthia H Seow; Anthony R Otley; A Hillary Steinhart; Anne Marie Griffiths; Gilaad G Kaplan; Eric I Benchimol Journal: Cochrane Database Syst Rev Date: 2014-08-21
Authors: David R Mack; Eric I Benchimol; Jeff Critch; Jennifer deBruyn; Frances Tse; Paul Moayyedi; Peter Church; Colette Deslandres; Wael El-Matary; Hien Huynh; Prévost Jantchou; Sally Lawrence; Anthony Otley; Mary Sherlock; Thomas Walters; Michael D Kappelman; Dan Sadowski; John K Marshall; Anne Griffiths Journal: J Can Assoc Gastroenterol Date: 2018-07-10