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Analysis of the therapeutic efficacy of different doses of budesonide in patients with active Crohn's ileocolitis depending on disease activity and localization

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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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Acknowledgements

Participating centers in the trial were: Klinikum der Universität, Regensburg (Prof. J. Schölmerich); Klinikum der Universität, Ulm (Prof. G. Adler); Städtische Kliniken, Oldenburg (Prof. U. Bär); Praxis Dr. Bokemeyer, Minden (Dr. B. Bokemeyer); Kliniken Dr. M. Schreiber, Munich (Dr. R. Burlefinger); Eberhard-Karls-Universitätsklinik, Tübingen (PD Dr. K. Deusch); Gemeinschaftspraxis Dr. Dreher/Dr. Nagel, Rottenburg/N. (Dr. F. Dreher, Dr. P. Nagel); Klinikum, Aschaffenburg (PD Dr. W. Fischbach); I. Klinik der Universität, Kiel (Prof. U. Fölsch); Klinikum der Universität, Essen (Prof. H. Goebell); Klinikum der Universität, Heidelberg (PD Dr. T. Goeser); Medizinische Klinik und Poliklinik der Universität, Düsseldorf (Dr. R. Lüthen); Praxis Dr. Orlemann, Rödermark (Dr. S. Orlemann); Praxis Dr. Hehemann, Beckum (Dr. K. Hehemann); Städtische Krankenhausanstalt, Esslingen (Dr. R. Hoffmann); Praxis Dr. Hüppe/Dr. Schenk, Herne (Dr. D. Hüppe, Dr. B. Schenk); Praxis Prof. Jakober, Tübingen (Prof. B. Jakober); Klinikum der J.W. v. Goethe-Universität, Frankfurt/M. (Dr. Dr. J. Stein); Städtische Krankenanstalt B.-Rosenhöhe, Bielefeld (Prof. U. Junge); Kreiskrankenhaus am Plattenwald, Bad Friedrichshall (Dr. P. Keller); Marien-Hospital, Marl (Dr. J. Keßel); Praxis Dr. Klugmann, Leipzig (Dr. T. Klugmann); Universitätsklinikum R. Virchow der FU Standort Wedding, Berlin (Dr. J. Körber); Praxis Dr. Küppers, Mannheim (Dr. B. Küppers); Krankenhaus, Düren (Prof. H. Leonhardt); Städtisches Krankenhaus, Wolfenbüttel (Prof. Limberg); Medizinische Fakultät (Charité) Humboldt Universität, Berlin (Prof. H. Lochs); Klinikum Innenstadt der Universität, Munich (Prof. K. Loeschke); Städtisches Krankenhaus, Friedrichshafen (Prof. H. Lorenz-Meyer); Klinikum, Leverkusen (Prof. H. Malchow); Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover, Burgwedel (Prof. P. Otto); Städtische Kliniken, Kassel (Prof. J. Pausch); Medizinische Klinik und Poliklinik der Universität, Tübingen (Dr. C. Gossen); Tabeakrankenhaus, Hamburg (Prof. A. Raedler); Klinikum der Universität, Göttingen (Prof. G. Ramadori); Medizinische Klinik und Poliklinik der Universität, Freiburg i. Br. (Prof. J. Rasenack); Praxis Dr. Rehmann, Lippstadt (Dr. I.H. Rehmann); Klinikum der Stadt, Ludwigshafen (Prof. J.F. Riemann); Klinikum der Universität, Bonn (Dr. C. Scheurlen); Praxis Dr. Pfaff, Gießen (Dr. R. Pfaff); Klinikum der Universität, Bonn (Dr. C. Schmidt); Fakultät für klinische Medizin Universität Heidelberg, Mannheim (Prof. M.V. Singer); Kreiskrankenhaus, Wangen (Prof. H.J. Steinhardt); Klinikum der Universität, Münster (PD Dr. R. Stoll); Evangelisches Krankenhaus Lütgendortmund, Dortmund (PD Dr. W. Wellmann); Städtische Kliniken, Darmstadt (Prof. H. Wietholtz); St.-Michael-Krankenhaus, Völklingen (Dr. D. Wördehoff); Praxis Dr. Sellinger, Ludwigshafen (Dr. M. Sellinger); Städtisches Krankenhaus Neuperlach, Munich (Prof. W. Schmitt); Medizinische Hochschule Hannover (Prof. M. Manns); Medizinische Poliklinik der Universität, Würzburg (PD Dr. M. Scheurlen); Oskar-Ziethen-Krankenhaus, Berlin (PD Dr. H.J. Schulz); Allg. Krankenhaus der Stadt Universitätsklinik, Vienna (Dipl.-Ing. Dr. H. Vogelsang); Klinikum der Universität, Mainz (Prof. R. Wanitschke); Medizinische Klinik I mit Poliklinik der FAU Erlangen-Nürnberg, Erlangen (Prof. C. Ell); Klinikum der RWTH, Aachen (Prof. S. Matern); Medizinische Universität, Lübeck (Prof. E.F. Stange); Klinikum Rechts der Isar der TU, Munich (Dr. W. Huber); Praxis Dr. Kramm, Berlin (Dr. H.-J. Kramm); Klinikum Küchwald, Chemnitz (Dr. V. Hempel); Juliusspital, Würzburg (Prof. I.O. Auer); Medizinische Klinik Universität, Rostock (PD Dr. J. Emmerich); Klinikum Kröllwitz M.-Luther-Universität H.-Wittenberg, Halle (Prof. W.E. Fleig).

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Authors and Affiliations

  1. Department of Internal Medicine, University of Regensburg, 93042, Regensburg, Germany

    H. Herfarth, V. Gross, T. Andus, I. Caesar & J. Schölmerich

  2. Department of Internal Medicine, University of Vienna, Vienna, Austria

    H. Vogelsang

  3. Department of Internal Medicine, University of Ulm, Ulm, Germany

    G. Adler

  4. Department of Internal Medicine, Hospital Leverkusen, Leverkusen, Germany

    H. Malchow

  5. Medicomp, Planegg, Germany

    A. Petri & M. Gierend

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  1. H. Herfarth
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  2. V. Gross
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  4. I. Caesar
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  6. G. Adler
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  7. H. Malchow
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  8. A. Petri
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  9. M. Gierend
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  10. J. Schölmerich
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The German/Austrian Budesonide Study Group

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Correspondence to H. Herfarth.

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Herfarth, H., Gross, V., Andus, T. et al. Analysis of the therapeutic efficacy of different doses of budesonide in patients with active Crohn's ileocolitis depending on disease activity and localization. Int J Colorectal Dis 19, 147–152 (2004). https://doi.org/10.1007/s00384-003-0529-5

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  • DOI: https://doi.org/10.1007/s00384-003-0529-5

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