Intestinal research · 2026
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.
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Saruta Masayuki, Omori Teppei, Nagaki Akira, Arai Yuki, Umeyama Minami, Kurosu Shinsuke, Kuramoto Kiyotoshi, Suzuki Yasuo
Аннотация
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).
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).