title: Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial.
abstract: OBJECTIVE
  This 1-year study aimed to assess low-dose budesonide therapy for maintenance of clinical remission in patients with collagenous colitis.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov (NCT01278082) and http://www.clinicaltrialsregister.eu (EudraCT: 2007-001315-31).
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Linköping, Sweden.
authors.forename: Andreas
authors.initials: A
authors.lastname: Münch
authors.affiliation: Department of Gastroenterology, Örebro University Hospital, and School of Health and Medical Sciences, Örebro University, Örebro, Sweden.
authors.forename: Johan
authors.initials: J
authors.lastname: Bohr
authors.affiliation: Centre for Digestive Disease, Hamburg, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Miehlke
authors.affiliation: Department of Gastroenterology, University Hospital, Malmö, Sweden.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Benoni
authors.affiliation: Department of Pathology, University Hospital, Malmö, Sweden.
authors.forename: Martin
authors.initials: M
authors.lastname: Olesen
authors.affiliation: Department of Pathology and Cytology, Aleris Medilab, Täby, Sweden.
authors.forename: Åke
authors.initials: Å
authors.lastname: Öst
authors.affiliation: Regional Hospital, Falun, Sweden.
authors.forename: Lars
authors.initials: L
authors.lastname: Strandberg
authors.affiliation: Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
authors.forename: Per M
authors.initials: PM
authors.lastname: Hellström
authors.affiliation: Department of Gastroenterology, University Hospital, Lund, Sweden.
authors.forename: Erik
authors.initials: E
authors.lastname: Hertervig
authors.affiliation: Gastroenterology, Private Practice, Berlin, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Armerding
authors.affiliation: Department of Gastroenterology, Regional Hospital, Usti nad Labem, Czech Republic.
authors.forename: Jiri
authors.initials: J
authors.lastname: Stehlik
authors.affiliation: Centre for Digestive Diseases, Karolinska University Hospital Huddinge, Stockholm, Sweden.
authors.forename: Greger
authors.initials: G
authors.lastname: Lindberg
authors.affiliation: Centre for Digestive Diseases, Karolinska University Hospital Solna, Stockholm, Sweden.
authors.forename: Jan
authors.initials: J
authors.lastname: Björk
authors.affiliation: Department of Gastroenterology, Ersta Hospital, Stockholm, Sweden.
authors.forename: Annika
authors.initials: A
authors.lastname: Lapidus
authors.affiliation: IBD Unit, Department of Gastroenterology, Sophiahemmet, Stockholm, Sweden.
authors.forename: Robert
authors.initials: R
authors.lastname: Löfberg
authors.affiliation: Department of Gastroenterology, Regional Hospital, Silkeborg, Denmark.
authors.forename: Ole
authors.initials: O
authors.lastname: Bonderup
authors.affiliation: Department of Gastroenterology, Amager Hospital, Copenhagen, Denmark.
authors.forename: Sören
authors.initials: S
authors.lastname: Avnström
authors.affiliation: Gastroenterology, Private Practice, Freiburg, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Rössle
authors.affiliation: Dr Falk Pharma GmbH, Freiburg, Germany.
authors.forename: Karin
authors.initials: K
authors.lastname: Dilger
authors.affiliation: Dr Falk Pharma GmbH, Freiburg, Germany.
authors.forename: Ralph
authors.initials: R
authors.lastname: Mueller
authors.affiliation: Dr Falk Pharma GmbH, Freiburg, Germany.
authors.forename: Roland
authors.initials: R
authors.lastname: Greinwald
authors.affiliation: Department of Gastroenterology, Örebro University Hospital, and School of Health and Medical Sciences, Örebro University, Örebro, Sweden.
authors.forename: Curt
authors.initials: C
authors.lastname: Tysk
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Linköping, Sweden.
authors.forename: Magnus
authors.initials: M
authors.lastname: Ström
mesh_terms: D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage* / Q000627:therapeutic use; D046729:Colitis, Collagenous / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D060046:Maintenance Chemotherapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D019819:Budesonide
keywords: MICROSCOPIC COLITIS; QUALITY OF LIFE