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DOP077. Low-dose budesonide maintains clinical remission and quality of life in collagenous colitis over a one year period: Results from the randomised, placebo-controlled BUC-63/COC trial

A. Münch1, J. Bohr2, S. Miehlke3, C. Benoni4, M. Olesen5, Å. Öst6, L. Strandberg7, P.M. Hellström8, E. Hertervig9, P. Armerding10, J. Stehlik11, G. Lindberg12, J. Björk12, A. Lapidus13, R. Löfberg14, O. Bonderup15, S. Avnström16, M. Rössle17, R. Muelller18, R. Greinwald18, C. Tysk19, M. Ström1, 1University Hospital, Gastoenterology and Hepatology, Linköping, Sweden, 2University Hospital, Gastroenterology, Örebro, Sweden, 3Center for Digestive Disease, Gastroenterology, Hamburg, Germany, 4University Hospital, Gastoenterology and Hepatology, Malmö, Sweden, 5University Hospital, Pathology, Malmö, Sweden, 6Medilab, Pathology, Stockholm, Sweden, 7Regional Hospital, Gastroenterology, Falun, Sweden, 8University Hospital, Gastoenterology and Hepatology, Uppsala, Sweden, 9University Hospital, Gastoenterology and Hepatology, Lund, Sweden, 10Private Practice, Gastroenterology, Berlin, Sweden, 11Regional Hospital, Gastroenterology, Usti nad Labem, Czech Republic, 12University Hospital, Gastroenterology, Stockholm, Sweden, 13Ersta hospital, Gastroenterology, Stockholm, Sweden, 14Sophiahemmet, IBD-Unit, Stockholm, Sweden, 15Regional Hospital, Gastroenterology, Silkeborg, Sweden, 16Regional Hospital, Gastroenterology, Copenhagen, Denmark, 17Private Practice, Gastroenterology, Freiburg, Germany, 18Dr. Falk Pharma, Research, Freiburg, Germany, 19University Hospital, Gastoenterology and Hepatology, Örebro, Sweden

Background

No controlled data exist so far showing the efficacy of longer treatment with lower dosages of budesonide in collagenous colitis (CC).

Methods

BUC-63/COC is the first RCT comparing the efficacy of low-dose budesonide (Budenofalk® 3 mg capsules; 2 capsules e.o.d, and 1 capsule e.o.d; average 4.5 mg/day;) versus placebo for 12-months maintenance therapy. Patients were randomised after an 8-week induction treatment with budesonide 9 mg/day in tapering doses. Primary endpoint was the rate of continuous clinical remission over 52 weeks (intention-to-treat [ITT] population). Clinical remission was defined as a mean of <3 stools/day, thereof <1 watery stools/day. Quality of Life (QoL) was assessed by Short Health Scale (SHS). Patients in remission at 52 weeks were followed for another 6 months without treatment to assess subsequent relapse risk.

Results

Out of 148 screened patients, 110 were enrolled into open-label induction phase. 92 patients (78 females), who were in remission at the end of the induction phase, were randomised and evaluated in the double-blind maintenance phase. The mean(SD) age was 58.8(11.0) years. Median (IQR) disease duration was 0.5 (0.1–3.8) years. At baseline, mean(SD) stool frequency was 1.7(0.6)/day (budesonide) and 1.8(0.9)/day (placebo); mean number of watery stools were 0.1(0.2)/day (budesonide) and 0.2(1.0)/day (placebo). After 52 weeks, 27 of 44 patients (61.4%) on budesonide and 8 of 48 patients (16.7%) on placebo were in clinical remission (ITT: difference 44.5%, 95% CI 26.9%; 62.7%; p < 0.0001 one sided). The QoL was unchanged after one year in the budesonide group but showed clinically relevant deterioration in placebo group. The 6 month follow-up revealed a high relapse rate (82%) in former budesonide treated patients with a median time (95% CI) to relapse of 40 (27–57) days. Mean(SD) treatment duration was 291(142) days (budesonide) and 138(125) days (placebo). Similar low numbers of patients in both groups (7 budesonide; 5 placebo) experienced an adverse drug reaction. Changes in serum cortisol levels from baseline to last visit in patients on low dose budesonide [Median (IQR): −0.04 (−0.13; 0.05) µmol/l; n = 42] did not differ from those on placebo [0.01 (−0.09; 0.07) µmol/l; n = 42).

Conclusion

Low-dose budesonide is an effective and safe long-term maintenance therapy in CC and maintains patients' QoL over 1-year of treatment. However, as relapses were frequent after cessation of treatment with budesonide, a sustained treatment longer than 1 year seems required.