A comparison of budesonide and prednisone for the treatment of active pediatric Crohn disease.
OBJECTIVE
Budesonide has been found effective in patients with mild and moderate Crohn disease and has been found to cause fewer side effects than prednisone. The use of oral budesonide has not been prospectively evaluated in children with Crohn disease. Therefore, the authors initiated a trial to compare remission and tolerance to budesonide and prednisone in children with mild or moderately active Crohn disease.


METHODS
A prospective randomized open controlled 12-week trial was carried out comparing pH modified release budesonide, 9 mg, versus prednisone, 40 mg, in children with active mild to moderate pediatric Crohn disease.


RESULTS
Thirty-three patients (20 boys and 13 girls; mean age, 14.3 years) enrolled and completed the study. The groups treated with budesonide and prednisone did not differ by age, onset of disease, location of disease, or disease activity. The remission rate at 12 weeks was 47% in the budesonide treatment group and 50% in the prednisone treatment group. Side effects occurred in 32% and 71% of patients treated with budesonide and prednisone, respectively (P< 0.05). Severity of cosmetic side effects was significantly lower in patients treated with budesonide (P< 0.01).


CONCLUSIONS
Remission rates for Crohn disease with budesonide and prednisone treatment in this study were similar. Pediatric patients treated with budesonide had significantly fewer side effects than patients treated with prednisone. Budesonide should be considered an alternative to prednisone in pediatric patients with mild to moderate disease activity.
Levine
Arie
A
Department of Pediatrics, B Sheba Medical Center, Tel Hashomer, Israel.
Weizman
Zvi
Z
Broide
Efrat
E
Shamir
Raanan
R
Shaoul
Ron
R
Pacht
Avi
A
Dinari
Gabriel
G
On
Avi
A
Weiss
Batya
B
Bujanover
Yoram
Y
D000293:Adolescent; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019819:Budesonide / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D011241:Prednisone / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D019819:Budesonide; D011241:Prednisone