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

What To Know

This article reports the final results of a Japanese, large-scale, prospective, multicenter, open-label post-marketing surveillance study of budesonide 2 mg rectal foam in patients with mild to moderate active ulcerative colitis.

Safety was assessed by adverse drug reactions and effectiveness by clinical remission rates and partial Mayo scores at weeks 2, 6, and the final evaluation. Adverse drug reactions were uncommon (4.3% overall); glucocorticoid-related events were reported in about 1.1% of patients.

Clinical remission and mean improvements in partial Mayo scores were observed as early as week 2 and increased by week 6, with benefits maintained across subgroups defined by disease phenotype, severity, prior topical therapy, age, and baseline advanced therapy use.

This is a post-marketing observational study (registry jRCT1080223802) conducted in routine clinical practice in Japan, so it describes real-world safety and effectiveness rather than randomized controlled trial efficacy. The study does not establish comparative effectiveness versus other treatments.

If you are considering rectal budesonide or are following a patient using it, these results support that the treatment was generally well tolerated and associated with clinical improvement in this large Japanese cohort.