Published in:
01-03-2004 | Original Article
Analysis of the therapeutic efficacy of different doses of budesonide in patients with active Crohn's ileocolitis depending on disease activity and localization
Authors:
H. Herfarth, V. Gross, T. Andus, I. Caesar, H. Vogelsang, G. Adler, H. Malchow, A. Petri, M. Gierend, J. Schölmerich, The German/Austrian Budesonide Study Group
Published in:
International Journal of Colorectal Disease
|
Issue 2/2004
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Abstract
Background and aims
The nonsystemic steroid budesonide has been used to treat active ileocecal and ileocolonic Crohn's disease (CD). This study investigated the optimal budesonide dose using a pH-dependent release formulation. The goal of treatment was the remission of CD (CDAI <150) within 6 weeks of treatment.
Patients and methods
The study was of randomized, double-blind, dose-finding design. Patients with active CD ileocolitis without steroid pretreatment were treated with 3×2 mg (n=39), 3×3 mg (n=33), or 3×6 mg (n=32) oral pH-modified released budesonide daily.
Results
The remission rates after 6 weeks were 36% with 3×2 mg, 55% with 3×3 mg, and 66% with 3×6 mg. Significantly more patients were in remission while treated with 3× 6mg than with 3×2 mg budesonide/day. Subgroup analyses revealed that patients with high disease activity (CDAI ≥ 300) or ileocolonic disease with disease manifestation distal to the transverse colon responded better to the highest budesonide dose.
Conclusion
Oral pH-modified released budesonide shows a dose-dependent effectiveness in patients with active ileocolonic CD. In the majority of patients 9 mg budesonide per day is sufficient. However, in patients with highly active disease or ileal disease with distal colonic manifestation higher doses of budesonide could increase the therapeutic response