Pharmacological intervention based on fecal calprotectin levels in patients with ulcerative colitis at high risk of a relapse: A prospective, randomized, controlled study

  • Lasson A
  • Ohman L
  • Per-Ove S
 et al. 
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INTRODUCTION: Pharmacological treatment of ulcerative colitis (UC) is traditionally divided into treatment of active disease and treatment to maintain remission. Recently, targeted therapy for patients at increased risk of a flare, using biomarkers to detect subclinical disease activity, has been proposed. The objective of this study was to assess if fecal calprotectin (FC), as a marker for inflammatory activity, can be used to guide medical intervention, to maintain remission in patients with UC. AIMS & METHODS: In this open-label, prospective, controlled study, 91 adult patients with UC in clinical remission, and under treatment with an oral 5-ASA agent, were randomized to either an intervention group (n=51) or a control group (n=40). All patients had at least one flare within one year prior to the inclusion. Patients on corticosteroids or anti-TNF therapy at inclusion were excluded. A stool sample for analysis of FC was delivered monthly during 18 months. A FC value of < 300 mug/g was set as cut-off for intervention. Provided that a second stool sample, delivered within a week, confirmed a FC value above the cut-off level, a dose escalation of the 5-ASA agent was performed in the intervention group. Accordingly, the dosages of Asacol (mesalazine), Pentasa (mesalazine), or Colazid (balsalazide) were increased to 4.8 g, 4.0 g and 6.75 g, respectively. This dose was maintained until the FC value was < 200 mug/g, but for at least 3 months. No action was taken in the control group until clinical signs of a relapse were recorded. The primary end-point was the number of patients to have relapsed at month 18. Secondary end-points were time to relapse and the need for corticosteroids. RESULTS: Eighteen (35.3 %) patients in the intervention group suffered at least one relapse over the 18-month period, compared with 20 (50.0 %) of those in the control group (p=0.231). The time to first relapse was 14.2 +/- 5.9 vs 12.1 +/- 6.9 (mean +/- SD) months in the two groups, respectively (p=0.125). Dose escalation due to a FC value above the cut-off level was accomplished in 28 (54.9 %) patients in the intervention group. In the control group, 28 patients (70.0 %) had at least one FC value > 300 mug/g. In all, 8 (28.6 %) and 16 (57.1%) of these patients with a FC > 300 mug/g experienced a relapse, in the intervention and control groups, respectively (p 300 mug/g. Thus, our results indicate, that FC-levels might be used to identify patients with UC at risk for an imminent disease flare before symptoms develop, and that dose escalation of a 5-ASA agent is a therapeutic option for these patients

Author-supplied keywords

  • *European
  • *calgranulin
  • *gastroenterology
  • *human
  • *patient
  • *randomized controlled trial
  • *relapse
  • *risk
  • *ulcerative colitis
  • adult
  • balsalazide
  • biological marker
  • colitis
  • control group
  • controlled study
  • corticosteroid
  • disease activity
  • disease exacerbation
  • drug therapy
  • hospital
  • marker
  • mesalazine
  • patient
  • recurrence risk
  • relapse
  • remission
  • risk
  • symptom
  • therapy
  • ulcerative colitis

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  • A Lasson

  • L Ohman

  • S Per-Ove

  • S Isaksson

  • O Uberbacher

  • K.-A. Ung

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