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Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial
Linköping University, Department of Clinical and Experimental Medicine, Division of Inflammation Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Center, Department of Gastroentorology.
Örebro University Hospital, and School of Health and Medical Sciences, Örebro University, Sweden .
Centre for Digestive Disease, Hamburg, Germany .
University Hospital, Malmö, Sweden .
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2016 (English)In: Gut, ISSN 0017-5749, E-ISSN 1468-3288, Vol. 65, no 1, 47-56 p.Article in journal (Refereed) Published
Abstract [en]

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: (NCT01278082) and (EudraCT: 2007-001315-31).

Place, publisher, year, edition, pages
B M J Group , 2016. Vol. 65, no 1, 47-56 p.
National Category
Clinical Medicine
URN: urn:nbn:se:liu:diva-112705DOI: 10.1136/gutjnl-2014-308363ISI: 000366400500010PubMedID: 25425655OAI: diva2:769681

Funding agencies: Dr Falk Pharma GmbH, Freiburg, Germany

Available from: 2014-12-08 Created: 2014-12-08 Last updated: 2016-03-09

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Münch, AndreasStröm, Magnus
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Division of Inflammation MedicineFaculty of Health SciencesDepartment of Gastroentorology
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