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Published in: International Journal of Colorectal Disease 2/2004

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
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Metadata
Title
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
Publication date
01-03-2004
Publisher
Springer-Verlag
Published in
International Journal of Colorectal Disease / Issue 2/2004
Print ISSN: 0179-1958
Electronic ISSN: 1432-1262
DOI
https://doi.org/10.1007/s00384-003-0529-5

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