Treatment of active and postactive ileal and colonic Crohn's disease with oral pH-modified-release budesonide. German Budesonide Study Group.
OBJECTIVE
Budesonide is a glucocorticoid with a high topical anti-inflammatory but low systemic activity due to its rapid hepatic inactivation. The aim of this open, multicenter study was to investigate efficacy and safety of oral pH-modified-release budesonide in patients with active Crohn's disease of the ileum and colon and in maintaining budesonide-induced remission in postactive Crohn's disease.


METHODS
81 patients (intention-to-treat) received 3 x 3 mg budesonide/day for 6 weeks, followed by 3 x 2 mg budesonide for another 6 weeks in case of response to initial treatment. Clinical and laboratory parameters were assessed at study entry as well as after 2, 4, 6 and 12 weeks of treatment.


RESULTS
On an intention-to-treat basis remission was induced in 54.3% of 81 patients with active Crohn's disease, 71.4% of 35 patients stayed in remission after the acute-phase treatment until the end of the trial. Typical steroid-related side effects were observed during the acute-phase treatment in only 18% of the patients. Duration, severity and extent of disease at study entry played no significant role in the outcome of the trial, but there was a tendency towards better results during the acute-phase treatment in patients with moderate disease activity and affection of the terminal ileum and proximal colon.


CONCLUSIONS
Budesonide could be an alternative to conventional steroid treatment in patients with active Crohn's disease.
Caesar
I
I
Department of Internal Medicine University of Regensburg.
Gross
V
V
Roth
M
M
Andus
T
T
Schmidt
C
C
Raedsch
R
R
Weber
A
A
Gierend
M
M
Ewe
K
K
Schölmerich
J
J
D000284:Administration, Oral; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D019819:Budesonide; D003108:Colonic Diseases / Q000188:drug therapy* / Q000473:pathology; D003424:Crohn Disease / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007077:Ileal Diseases / Q000188:drug therapy* / Q000473:pathology; D008099:Liver / Q000378:metabolism; D008297:Male; D011282:Pregnenediones / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D012074:Remission Induction; D012449:Safety; D013997:Time Factors; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D011282:Pregnenediones; D019819:Budesonide