Background: Oral budesonide has been proven effective in short- and long-term treatment of collagenous colitis; however, symptom relapse frequently occurs after drug withdrawal. The aim of this study was to identify the risk factors for symptom relapse in patients with collagenous colitis after withdrawal of short-term budesonide therapy.
Methods: One hundred twenty-three patients from 4 randomized controlled studies who achieved clinical remission after short-term treatment with budesonide (9 mg/d) were analyzed, including 40 patients receiving subsequent budesonide maintenance therapy (6 mg/d) for 6 months and 83 patients without active maintenance treatment. Variables available for analysis were age, sex, baseline stool frequency, duration of diarrhea, collagenous band thickness, and lamina propria inflammation. Hazard ratios (HRs) and their 95% confidence intervals (CIs) were calculated by Cox proportional hazard model.
Results: The overall symptom relapse rate was 61%. By multivariate analysis, a baseline stool frequency >5 per day (HR, 3.95; 95% CI, 1.08–14.39), history of diarrhea >12 months (HR, 1.77; 95% CI, 1.04–3.03), and the absence of budesonide maintenance therapy (HR, 2.71; 95% CI, 1.37–5.38) were associated with symptom relapse. The time to relapse was shorter in patients with a baseline stool frequency >5 per day (56 versus 199 d, P = 0.024), as in those with history of diarrhea >12 months (56 versus 220 d, P = 0.009). Budesonide maintenance therapy delayed the time to relapse (56 versus 207 d, P = 0.005).
Conclusions: Our data demonstrate that a high stool frequency at baseline and a long duration of diarrhea are risk factors for symptom relapse in collagenous colitis, whereas budesonide maintenance therapy is a protective factor against symptom relapse.
Article first published online 7 November 2013
*Center for Digestive Diseases, Hamburg, Germany;
†Department of Gastroenterology, Aalborg Hospital, Aalborg, Denmark;
‡Medical Department I, Siloah Hospital, Hannover, Germany;
§Medical Department III, University Hospital, Dresden, Germany;
‖Institute for Medical Informatics and Biometry, Technical University, Dresden, Germany;
¶Lanserhof Hamburg GmbH, Hamburg, Germany;
**Institute of Pathology, Aalborg Hospital, Aalborg, Denmark;
††Institute of Pathology, Klinikum Bayreuth, Bayreuth, Germany;
‡‡Institute of Pathology, University Hospital, Dresden, Germany; and
§§Diagnostic Center, Section of Gastroenterology, Regional Hospital Silkeborg, Silkeborg, Denmark.
Reprints: Stephan Miehlke, MD, Center for Digestive Diseases, Eppendorf, Eppendorfer Landstraße 42, Hamburg 20249, Germany (e-mail: email@example.com).
The authors have no conflicts of interest to disclose.
Received July 31, 2013
Accepted August 26, 2013