Pharmacological intervention based on fecal calprotectin levels in patients with ulcerative colitis at high risk of a relapse: A prospective, randomized, controlled study. Issue 1 (February 2015)

• Record Type: Journal Article
• Authors: Lasson, Anders; Öhman, Lena; Stotzer, Per-Ove; Isaksson, Stefan; Überbacher, Otto; Ung, Kjell-Arne; Strid, Hans
• Is Part Of: United European Gastroenterology journal. Volume 3:Issue 1(2015:Feb.)
• Page Start: 72
• Page End: 79
• Publication Date: 2015-02
• Subjects: 5-Aminosalicylate -- biomarker -- calprotectin -- fecal calprotectin -- randomized controlled study -- relapse rate -- ulcerative colitis; Gastroenterology -- Periodicals; Periodicals; 616.33005
• DOI: 10.1177/2050640614560785
• Languages: English
• ISSNs: 2050-6406

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). Conclusion: 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.