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P361. Risk factors for symptom relapse in collagenous colitis after withdrawal of short-term budesonide therapy

S. Miehlke1, J.B. Hansen2, A. Madisch3, F. Schwarz4, E. Kuhlisch5, A. Morgner6, P.S. Teglbjaerg7, M. Vieth8, D. Aust9, O.K. Bonderup10, 1Magen-Darm-Zentrum, Facharztzentrum Eppendorf, Hamburg, Germany, 2Aalborg Hospital, Department of Gastroenterology, Aalborg, Denmark, 3Siloah Hospital, Medical Department I, Hannover, Germany, 4University Hospital, Medical Department III, Dresden, Germany, 5Technical University, Institute for Medical Informatics and Biometry, Dresden, Germany, 6Lanserhof Hamburg GmbH, LANS MEDICUM, Hamburg, Germany, 7Aalborg Hospital, Institute of Pathology, Aalborg, Denmark, 8Klinikum Bayreuth, Institute for Pathology, Bayreuth, Germany, 9University Hospital, Institute for Pathology, Dresden, Germany, 10Regional Hospital Silkeborg, Diagnostic Center, Section of Gastroenterology, Silkeborg, Denmark

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 risk factors for symptom relapse in patients with collagenous colitis after withdrawal of short-term budesonide therapy.

Methods

123 patients from 4 randomized controlled studies who achieved clinical remission after short-term treatment with budesonide (9 mg/day) were analyzed, including 40 patients receiving subsequent budesonide maintenance therapy (6 mg/day) for 6 months and 83 patients without active maintenance treatment. Variables available for analysis were age, gender, baseline stool frequency, duration of diarrhea, collagenous band thickness, and lamina propria inflammation. Hazard ratios (HR) were calculated by logistic regression analysis with 95% confidence intervals.

Results

The overall symptom relapse rate was 61%. By multivariate analysis, a baseline stool frequency >5/day (HR 3.95; 1.08–14.39), a history of diarrhea >12 months (HR 1.77; 1.04–3.03), and the absence of budesonide maintenance therapy (HR 2.71; 1.37–5.38) were associated with symptom relapse. The time to relapse was shorter in patients with a baseline stool frequency >5/day (56 vs. 199 days, p = 0.024), as in those with a history of diarrhea >12 months (56 vs. 220 days, p = 0.009). Budesonide maintenance therapy delayed the time to relapse (56 versus 207 days, p = 0.005).

Conclusion

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, while budesonide maintenance therapy is a protective factor against symptom relapse.