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Original Articles
- Safety and effectiveness of budesonide rectal foam for ulcerative colitis in a large-scale, multicenter, prospective observational study: final report of post-marketing surveillance in Japan
- Masayuki Saruta, Teppei Omori, Akira Nagaki, Yuki Arai, Minami Umeyama, Shinsuke Kurosu, Kiyotoshi Kuramoto, Yasuo Suzuki
- Received July 31, 2025 Accepted November 13, 2025 Published online February 11, 2026
- DOI: https://doi.org/10.5217/ir.2025.00164 [Epub ahead of print]
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Abstract
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Supplementary Material
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ePub - Background/Aims
Budesonide rectal foam was approved in Japan in 2017 for mild to moderate active ulcerative colitis (UC). This is the final report of post-marketing surveillance to evaluate real-world safety and effectiveness.
Methods
This Japanese large-scale, prospective, multicenter, open-label observational study included patients with active-phase mild to moderate UC newly started on budesonide 2 mg rectal foam. Safety was evaluated by adverse drug reactions (ADRs). Effectiveness was evaluated using clinical remission rates and partial Mayo scores. Effectiveness by background (disease phenotype, severity, clinical course, age, prior topical therapy, baseline advanced therapy [biologicals/Janus kinase inhibitors]) was also assessed.
Results
There were 633 and 503 patients in the safety and effectiveness analyses, respectively. ADRs occurred in 4.3% (27/633) of patients. Eight glucocorticoid-related ADRs occurred in 7 patients (1.1%). Clinical remission rates were 44.2% (165/373), 72.1% (191/265), and 69.8% (333/477) at week 2, week 6, and the final evaluation, respectively. There were statistically significant changes from baseline in partial Mayo scores at all timepoints (all P< 0.0001 vs. baseline). At 2, 4, 6, and 6–12 weeks, mean± standard deviation changes from baseline in partial Mayo scores were −2.1 ± 1.9, −2.7 ± 2.1, −3.1 ± 2.3, and −3.4 ± 2.3 points, respectively. Statistically significant improvements were maintained at all timepoints in subgroup analyses by background (disease phenotype, severity, clinical course, age, prior topical therapy, baseline advanced therapy).
Conclusions
No new safety concerns were identified. Partial Mayo score improved in a variety of patient background factors. Health condition improvements were confirmed in this Japanese post-marketing surveillance. (Japan Registry of Clinical Trials, identifier jRCT1080223802)
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- Inflammatory bowel diseases
- Predictive factors for achievement of mucosal healing by budesonide 2-mg foam in ulcerative colitis: a pooled analysis of data from two clinical trials
- Toshifumi Hibi, Makoto Naganuma, Eisei Oda, Yoji Yamada, Yoshitomo Chujoh, Ryoichi Yoshihara, Mamoru Watanabe
- Intest Res 2020;18(1):56-68. Published online December 11, 2019
- DOI: https://doi.org/10.5217/ir.2019.00064
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Abstract
PDFPubReaderePub
- Background/Aims
Mucosal healing (MH) of distal lesions in ulcerative colitis (UC) has recently been confirmed with budesonide 2-mg foam (BF) treatment in 2 clinical trials; however, few studies have investigated the predictive factors for complete MH.
Methods
We conducted a post hoc analysis using pooled data from phase II and III clinical trials evaluating the efficacy and safety of BF for UC. Additionally, we analyzed the relationships between complete MH and baseline factors and clinical symptoms from baseline to week 6.
Results
Among the 291 Japanese patients from the 2 pooled clinical studies, 119 patients in the BF twice a day group and 117 in the placebo group were included in the full analysis set. The proportion of patients with a rectal bleeding (RB) subscore of 0 was significantly higher in the BF group than in the placebo group after a 5-day treatment (P<0.05). After a 2-day treatment, significantly more patients in the BF group had a stool frequency (SF) subscore of 0 than patients in the placebo group (P<0.05). Multivariate analysis showed that complete MH at week 6 was influenced by baseline SF subscore and 5-aminosalicylic acid (5-ASA) enema or suppository use (P=0.0086 and P=0.0015, respectively). The relationship between complete MH at week 6 and RB subscore after week 2 was also confirmed.
Conclusions
Normal SF at baseline, history of 5-ASA topical product use, and elimination of RB after week 2 are suggested predictors of complete MH at week 6 with twice-daily BF treatment. -
Citations
Citations to this article as recorded by
- 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 Kobayashi, Kei Moriya, Toshimitsu Fujii, Shigeki Bamba, Shinichiro Shinzaki, Akihiro Yamada, Takashi Hisabe, Shintaro Sagami, Shuji Hibiya, Takahiro Amano, Noritaka Takatsu, Katsutoshi Inagaki, Ken-ichi Iwayama, Toshifumi Hibi
Intestinal Research.2025; 23(2): 157. CrossRef - Impact of twice‐daily budesonide foam administration on early clinical response and endoscopic remission in patients with ulcerative colitis: a post hoc analysis
Kenji Watanabe, Fumihito Hirai, Kiyonori Kobayashi, Ken Takeuchi, Shinsuke Kurosu, Katsutoshi Inagaki, Ken‐ichi Iwayama, Makoto Naganuma
Journal of Gastroenterology and Hepatology.2024; 39(11): 2367. CrossRef - Precision medicine and drug optimization in adult inflammatory bowel disease patients
Sophie Vieujean, Edouard Louis
Therapeutic Advances in Gastroenterology.2023;[Epub] CrossRef - The Prognostic Value of Residual Nonrectal Inflammation in Ulcerative Colitis
Eun Ae Kang
Gut and Liver.2022; 16(3): 487. CrossRef - Bowel frequency (night) and urgent defecation are improved by budesonide foam in patients with ulcerative colitis: a retrospective observational study
Ryosuke Miyazaki, Toshiyuki Sakurai, Mariko Shimada, Yuko Iwashita, Naoki Shibuya, Yoshihiro Akita, Haruna Miyashita, Yuki Maruyama, Masayuki Saruta
BMC Gastroenterology.2022;[Epub] CrossRef - Personalized medicine in inflammatory bowel disease: Perspectives on Asia
Su Hyun Park, Sang Hyoung Park
Journal of Gastroenterology and Hepatology.2022; 37(8): 1434. CrossRef - Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α
Jihye Park, Jae Hee Cheon
The Korean Journal of Internal Medicine.2022; 37(5): 895. CrossRef - Budesonide MMX in the Treatment of Ulcerative Colitis: Current Perspectives on Efficacy and Safety
Giovanni Maconi, Deborah Camatta, Rosanna Cannatelli, Francesca Ferretti, Anna Carvalhas Gabrielli, Sandro Ardizzone
Therapeutics and Clinical Risk Management.2021; Volume 17: 285. CrossRef
- 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
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- 190 Download
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