Can Fecal Calprotectin Predict Initiation or Intensification of IBD Therapy: A Cohort Analysis

Abstract

Introduction: Fecal calprotectin is a marker of disease activity in inflammatory bowel disease (IBD). The aim of this study is to assess if fecal calprotectin (FC) levels can predict therapy escalation in patients with IBD. A secondary outcome was to observe patients who did not have IBD and whether or not elevated FC levels could predict diagnosis within one year. Methods: Statistical analysis was performed on 126 consecutive patients who presented to outpatient clinics with lower gastrointestinal symptoms who either had established IBD or suspected new IBD and provided high range FC samples within 4 weeks of their scheduled endoscopic assessment. These patients were followed up for at least one year and monitored clinically for any change in symptomatology, escalation of therapy, or development of IBD, confirmed endoscopically. Escalation of therapy included any intensification in dosage, frequency, or addition of new therapies for IBD such as: 5-ASA agents, corticosteroids, immunosuppressants, TNF antagonists, leukocyte trafficking inhibitors, investigational drugs or need for surgery. Results: 126 patients, of whom 66 were females, were included with a mean age of 44.4 years (+-16.7). Among these patients, a total of 72 patients were found to have IBD. In patients who had IBD as well as FC levels greater than 100 μg/g, a total of 66% (33/50) went on to have escalation in therapy within one year, whereas in those patients with FC levels that were below 100 μg/g, only 18% (4/22) had an increase in their therapy. For patients who had known IBD but who had endoscopically inactive disease activity, FC levels greater than 100 μg/g resulted in 33% (2/6) of patients receiving escalation in therapy, whereas FC levels less than 100 μg/g had 0% (0/12) patients with escalation in therapy. Lastly, for patients who did not have IBD and had normal endoscopic evaluation with an elevated FC level greater than 100 μg/g, 0% (0/17) ended up being diagnosed with IBD within one year. Conclusion: FC is a useful test in patients when used in combination with endoscopy for patients who have known IBD. For those patients, regardless of endoscopic activity, FC levels less than 100 μg/g rarely require escalation of therapy within the next full year of monitoring. Also, patients who did not have known IBD and had normal endoscopic evaluation, FC levels greater than 100 μg/g, did not have a correlation with new diagnosis of IBD within one year.