| 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 |
Taku Kobayashi1 
, Kei Moriya2
, Toshimitsu Fujii3
, Shigeki Bamba4
, Shinichiro Shinzaki5,6
, Akihiro Yamada7
, Takashi Hisabe8
, Shintaro Sagami1,9
, Shuji Hibiya3
, Takahiro Amano5
, Noritaka Takatsu8
, Katsutoshi Inagaki10
, Ken-ichi Iwayama11
, Toshifumi Hibi1
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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
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Correspondence:
Taku Kobayashi, Tel: +81-3-5791-6487, Fax: +81-3-5791- 489,
Email: drkobataku@gmail.com
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Received: 11 January 2024 • Revised: 17 April 2024 • Accepted: 29 April 2024 |
| 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. |
| Key Words:
Bowel urgency, Colitis, ulcerative, Quality of life |
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