You are here

  • Home
  • Archive
  • Volume 65, Issue 1
  • Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial

Article Text

Article menu
XML
Inflammatory bowel disease
Original article
Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial
  1. Andreas Münch1,
  2. Johan Bohr2,
  3. Stephan Miehlke3,
  4. Cecilia Benoni4,
  5. Martin Olesen5,
  6. Åke Öst6,
  7. Lars Strandberg7,
  8. Per M Hellström8,
  9. Erik Hertervig9,
  10. Peter Armerding10,
  11. Jiri Stehlik11,
  12. Greger Lindberg12,
  13. Jan Björk13,
  14. Annika Lapidus14,
  15. Robert Löfberg15,
  16. Ole Bonderup16,
  17. Sören Avnström17,
  18. Martin Rössle18,
  19. Karin Dilger19,
  20. Ralph Mueller19,
  21. Roland Greinwald19,
  22. Curt Tysk2,
  23. Magnus Ström1
  24. on behalf of the BUC-63 investigators
  1. 1Division of Gastroenterology and Hepatology, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Linköping, Sweden
  2. 2Department of Gastroenterology, Örebro University Hospital, and School of Health and Medical Sciences, Örebro University, Örebro, Sweden
  3. 3Centre for Digestive Disease, Hamburg, Germany
  4. 4Department of Gastroenterology, University Hospital, Malmö, Sweden
  5. 5Department of Pathology, University Hospital, Malmö, Sweden
  6. 6Department of Pathology and Cytology, Aleris Medilab, Täby, Sweden
  7. 7Regional Hospital, Falun, Sweden
  8. 8Department of Medical Sciences, Uppsala University, Uppsala, Sweden
  9. 9Department of Gastroenterology, University Hospital, Lund, Sweden
  10. 10Gastroenterology, Private Practice, Berlin, Germany
  11. 11Department of Gastroenterology, Regional Hospital, Usti nad Labem, Czech Republic
  12. 12Centre for Digestive Diseases, Karolinska University Hospital Huddinge, Stockholm, Sweden
  13. 13Centre for Digestive Diseases, Karolinska University Hospital Solna, Stockholm, Sweden
  14. 14Department of Gastroenterology, Ersta Hospital, Stockholm, Sweden
  15. 15IBD Unit, Department of Gastroenterology, Sophiahemmet, Stockholm, Sweden
  16. 16Department of Gastroenterology, Regional Hospital, Silkeborg, Denmark
  17. 17Department of Gastroenterology, Amager Hospital, Copenhagen, Denmark
  18. 18Gastroenterology, Private Practice, Freiburg, Germany
  19. 19Dr Falk Pharma GmbH, Freiburg, Germany
  1. Correspondence to Dr Andreas Münch, Division of Gastroenterology and Hepatology, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Linköping 58185, Sweden; andreas.munch{at}lio.se

Abstract

Objective This 1-year study aimed to assess low-dose budesonide therapy for maintenance of clinical remission in patients with collagenous colitis.

Design A prospective, randomised, placebo-controlled study beginning with an 8-week open-label induction phase in which patients with histologically confirmed active collagenous colitis received budesonide (Budenofalk, 9 mg/day initially, tapered to 4.5 mg/day), after which 92 patients in clinical remission were randomised to budesonide (mean dose 4.5 mg/day; Budenofalk 3 mg capsules, two or one capsule on alternate days) or placebo in a 12-month double-blind phase with 6 months treatment-free follow-up. Primary endpoint was clinical remission throughout the double-blind phase.

Results Clinical remission during open-label treatment was achieved by 84.5% (93/110 patients). The median time to remission was 10.5 days (95% CI (9.0 to 14.0 days)). The maintenance of clinical remission at 1 year was achieved by 61.4% (27/44 patients) in the budesonide group versus 16.7% (8/48 patients) receiving placebo (treatment difference 44.5% in favour of budesonide; 95% CI (26.9% to 62.7%), p<0.001). Health-related quality of life was maintained during the 12-month double-blind phase in budesonide-treated patients. During treatment-free follow-up, 82.1% (23/28 patients) formerly receiving budesonide relapsed after study drug discontinuation. Low-dose budesonide over 1 year resulted in few suspected adverse drug reactions (7/44 patients), all non-serious.

Conclusions Budesonide at a mean dose of 4.5 mg/day maintained clinical remission for at least 1 year in the majority of patients with collagenous colitis and preserved health-related quality of life without safety concerns. Treatment extension with low-dose budesonide beyond 1 year may be beneficial given the high relapse rate after budesonide discontinuation.

Trial registration numbers http://www.clinicaltrials.gov (NCT01278082) and http://www.clinicaltrialsregister.eu (EudraCT: 2007-001315-31).

  • MICROSCOPIC COLITIS
  • QUALITY OF LIFE

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/gutjnl-2014-308363

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Supplementary materials

    • Supplementary Data

      This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

      Files in this Data Supplement: