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P567. Budesonide induces clinical remission and improves quality of life in active collagenous colitis: results from the open-label induction phase of BUC-63/COC

A. Münch1, J. Bohr2, C. Benoni3, M. Olesen3, Å. Öst4, H. Hjortswang1, P.M. Hellström5, L. Strandberg6, J. Björk7, E. Hertervig8, G. Lindberg7, A. Lapidus7, R. Löfberg7, S. Miehlke9, C. Kirsch10, P. Armerding11, O. Bonderup12, J. Stehlik13, R. Müller14, R. Greinwald14, C. Tysk15, M. Ström1, 1University Hospital, Gastroenterology, Linköping, Sweden, 2University Hospital, Gastroenterology, Örebro, Sweden, 3University Hospital, Gastroenterology, Malmö, Sweden, 4Medilab, Pathology, Stockholm, Sweden, 5University Hospital, Gastroenterology, Uppsala, Sweden, 6Regional hospital, Falun, Sweden, 7University Hospital, Stockholm, Sweden, 8University Hospital, Lund, Sweden, 9Center for Digestive Disease, Hamburg, Germany, 10University Hospital, Dresden, Germany, 11Priviate practice, Berlin, Germany, 12Regional hospital, Silkeborg, Denmark, 13Regional hospital, Usti nad Labem, Czech Republic, 14Falk Pharma, Freiburg, Germany, 15University Hospital, Gastroenterology, Örebro, Sweden

Background

Collagenous colitis (CC) represents a well-established cause of chronic, non-bloody diarrhoea. BUC-63/COC is a RCT of maintenance therapy in CC with budesonide 4.5 mg/day given for 12 months after an open-label, 8 week induction treatment with budesonide 9 mg/day for 4 weeks followed by 6 mg/day for 2 weeks, and alternating 6 mg and 3 mg/day every second day for another 2 weeks.

Methods

Inclusion criteria were a diagnosis of CC with symptoms of active disease, defined by Hjortswang [1] as a mean of ≥3 stools/day/week, thereof ≥1 watery stools/day/week. We here present results of the open-label induction phase. Primary endpoint was clinical remission at week 8, defined as a mean of <3 stools/day/week, and a mean of <1 watery stool/day/week. Quality of life (QoL) was assessed by Short Health Scale (SHS).

Results

Out of 148 screened patients, 110 were enrolled; 93 patients (76 females) could be evaluated in the open-label treatment phase. The mean (SD) age was 59.2 (10.8) years. At baseline, mean (SD) stool frequency was 5.5 (2.1)/day and mean number of watery stools 4.4 (2.3)/day. After 4 and 8 weeks (LOCF), 78 (84%) and 83 (89%) of the patients were in clinical remission, respectively. The median (IQR) time to remission was 10 (8–21) days. In patients who achieved clinical remission the mean SHS (100 mm VAS) for the 4 QoL dimensions (1: symptom burden, 2: social function, 3: disease-related worry, and 4: general well-being) improved from 75, 68, 65, and 54, to 11, 9, 14, and 19 respectively at 8 weeks, indicating a significant improvement of QoL (p < 0.0001). On the other hand, patients in non-remission had a much lower improvement of their scores, which was also statistically non-significant in the dimension social function (p = 0.131) and general well-being (p = 0.379).

Conclusion

This study confirms the very good efficacy of budesonide to induce clinical remission in CC and significantly improve quality of life. The SHS shows to be a responsive measure of QoL, as shown by parallel improvement of clinical symptoms and changes of QoL. The value of the disease activity criteria by Hjortswang et al. in clinical trials is confirmed.