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

Place, publisher, year, edition, pages
BMJ Publishing Group , 2016. Vol. 65, no 1, p. 47-56
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Gastroenterology and Hepatology
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URN: urn:nbn:se:oru:diva-47352DOI: 10.1136/gutjnl-2014-308363ISI: 000366400500010PubMedID: 25425655Scopus ID: 2-s2.0-84955571349OAI: oai:DiVA.org:oru-47352DiVA, id: diva2:891942
Note

Funding Agency:

Dr Falk Pharma GmbH, Freiburg, Germany 

Available from: 2016-01-08 Created: 2016-01-08 Last updated: 2018-07-09Bibliographically approved

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Bohr, JohanTysk, Curt

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