title: Pharmacological intervention based on fecal calprotectin levels in patients with ulcerative colitis at high risk of a relapse: A prospective, randomized, controlled study.
abstract: BACKGROUND
  Targeted therapy, using biomarkers to assess disease activity in ulcerative colitis (UC), has been proposed.
  
  
  OBJECTIVE
  The objective of this study was to evaluate whether pharmacological intervention guided by fecal calprotectin (FC) prolongs remission in patients with UC.
  
  
  METHODS
  A total of 91 adults with UC in remission were randomized to an intervention group or a control group. Analysis of FC was performed monthly, during 18 months. A FC value of 300 µg/g was set as the cut-off for intervention, which was a dose escalation of the oral 5-aminosalicylate (5-ASA) agent. The primary study end-point was the number of patients to have relapsed by month 18.
  
  
  RESULTS
  There were relapses in 18 (35.3%) and 20 (50.0%) patients in the intervention and the control groups, respectively (p = 0.23); and 28 (54.9%) patients in the intervention group and 28 (70.0%) patients in the control group had a FC > 300 µg/g, of which 8 (28.6%) and 16 (57.1%) relapsed, respectively (p < 0.05).
  
  
  CONCLUSIONS
  Active intervention significantly reduced relapse rates, although no significant difference was reached between the groups overall. Thus, FC-levels might be used to identify patients with UC at risk for a flare, and a dose escalation of their 5-ASA agent is a therapeutic option for these patients.
authors: Department of Internal Medicine, Södra Älvsborgs Hospital, Borås, Sweden.
authors: Anders
authors: A
authors: Lasson
authors: Department of Internal Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden ; Department of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Sweden.
authors: Lena
authors: L
authors: Öhman
authors: Department of Internal Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.
authors: Per-Ove
authors: PO
authors: Stotzer
authors: Department of Internal Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden ; Department of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Sweden.
authors: Stefan
authors: S
authors: Isaksson
authors: Department of Internal Medicine, Hallands Hospital, Varberg, Sweden.
authors: Otto
authors: O
authors: Überbacher
authors: Department of Internal Medicine, Skaraborgs Hospital, Skövde, Sweden.
authors: Kjell-Arne
authors: KA
authors: Ung
authors: Department of Internal Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.
authors: Hans
authors: H
authors: Strid
keywords: 5-Aminosalicylate; biomarker; calprotectin; fecal calprotectin; randomized controlled study; relapse rate; ulcerative colitis
references: Scand J Gastroenterol. 2006 Oct;41(10):1196-203
references: 16990205
references: Am J Gastroenterol. 2005 Nov;100(11):2478-85
references: 16279903
references: Scand J Gastroenterol. 1992 Sep;27(9):793-8
references: 1411288
references: Cochrane Database Syst Rev. 2012 Oct 17;10:CD000544
references: 23076890
references: Gut. 2001 Dec;49(6):783-9
references: 11709512
references: Inflamm Bowel Dis. 2008 Oct;14(10):1413-8
references: 18521900
references: Am J Gastroenterol. 2002 Feb;97(2):389-96
references: 11866278
references: Inflamm Bowel Dis. 2008 Jan;14(1):40-6
references: 18022866
references: Gastroenterology. 2000 Jul;119(1):15-22
references: 10889150
references: Clin Gastroenterol Hepatol. 2014 Nov;12(11):1887-93.e3
references: 24793028
references: Inflamm Bowel Dis. 2008 Sep;14(9):1229-35
references: 18398894
references: N Engl J Med. 1987 Dec 24;317(26):1625-9
references: 3317057
references: Inflamm Bowel Dis. 2008 May;14(5):669-73
references: 18240279
references: Gastroenterology. 2002 Aug;123(2):450-60
references: 12145798
references: Am J Gastroenterol. 2007 Aug;102(8):1692-701
references: 17555460
references: Cochrane Database Syst Rev. 2012 Oct 17;10:CD000543
references: 23076889
references: J Crohns Colitis. 2010 Jun;4(2):144-52
references: 21122498
references: Inflamm Bowel Dis. 2012 Oct;18(10):1894-9
references: 22238138
references: Eur J Gastroenterol Hepatol. 1995 Nov;7(11):1025-30
references: 8680900
references: Gastroenterology. 2009 Dec;137(6):1934-43.e1-3
references: 19766640
references: Am J Gastroenterol. 2002 Jun;97(6):1398-407
references: 12094857
references: Gut. 2005 Mar;54(3):364-8
references: 15710984
references: Scand J Gastroenterol. 2004 Oct;39(10):1017-20
references: 15513345
references: J Crohns Colitis. 2012 Dec;6(10):991-1030
references: 23040451
references: Neurogastroenterol Motil. 2013 Sep;25(9):756-e578
references: 23731196
references: Int J Colorectal Dis. 2014 Apr;29(4):485-91
references: 24343276
references: J Crohns Colitis. 2011 Oct;5(5):477-83
references: 21939925
references: World J Gastroenterol. 2008 Sep 28;14(36):5584-9; discussion 5588
references: 18810778
references: Clin Gastroenterol Hepatol. 2012 Oct;10(10):1143-51
references: 22610010
references: Inflamm Bowel Dis. 2006 Jul;12(7):543-50
references: 16804390
references: Inflamm Bowel Dis. 2013 Sep;19(10):2111-7
references: 23883959
references: Am J Gastroenterol. 2008 Aug;103(8):2007-14
references: 18802997
references: Inflamm Bowel Dis. 2009 Dec;15(12):1851-8
references: 19462421