Intest Res.
2025 Apr;23(2):157-169. 10.5217/ir.2024.00005.
Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study
- Kobayashi T
1 - Moriya K2
- Fujii T3
- Bamba S4
- Shinzaki S5,6
- Yamada A7
- Hisabe T8
- Sagami S1,9
- Hibiya S3
- Amano T5
- Takatsu N8
- Inagaki K10
- Iwayama Ki11
- Hibi T1
- Affiliations
-
- 1Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan
- 2Department of Gastroenterology, Nara Medical University, Kashihara, Japan
- 3Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan
- 4Division of Digestive Endoscopy, Shiga University of Medical Science, Otsu, Japan
- 5Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Japan
- 6Department of Gastroenterology, Hyogo Medical University, Nishinomiya, Japan
- 7Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan
- 8Department of Gastroenterology, Fukuoka University Chikushi Hospital, Chikushino, Japan
- 9Department of Gastroenterology and Hepatology, Kitasato University Kitasato Institute Hospital, Tokyo, Japan
- 10Medical Science Group, Medical Department, EA Pharma Co., Ltd., Tokyo, Japan
- 11Medical Department, Kissei Pharmaceutical Co., Ltd., Tokyo, Japan
- KMID: 2567622
- DOI: http://doi.org/10.5217/ir.2024.00005
Abstract
- Background/Aims
Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC.
Methods
This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.
Results
Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.
Conclusions
The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.
