Anders Lasson1, Lena Öhman2, Per-Ove Stotzer3, Stefan Isaksson2, Otto Überbacher4, Kjell-Arne Ung5, Hans Strid3. 1. Department of Internal Medicine, Södra Älvsborgs Hospital, Borås, Sweden. 2. Department of Internal Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden ; Department of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Sweden. 3. Department of Internal Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden. 4. Department of Internal Medicine, Hallands Hospital, Varberg, Sweden. 5. Department of Internal Medicine, Skaraborgs Hospital, Skövde, Sweden.
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.
RCT Entities:
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.
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