Real-world safety and efficacy of twice-daily budesonide 2-mg foam in patients with ulcerative colitis: interim analysis of post-marketing surveillance

Background: Budesonide foam 2 mg twice daily induced complete mucosal healing in patients with mild-to-moderate ulcerative colitis (UC) a phase 3 study. Post-marketing surveillance is underway to assess the real-world outcomes UC patients.Research design and methods: The authors performed an interim analysis of post-marketing 182 who received budesonide rectally.Results: was prescribed 76.4% for 7.6 ± 3.8 weeks (mean standard deviation). Seven (3.8%) had at least one adverse drug reaction (ADR). A serious ADR enteritis infectious glucocorticoid-related ADRs acne hypertrichosis were observed patient (0.5%) each. partial Mayo scores significantly decreased from baseline week proctitis, left-sided colitis, pancolitis (p < 0.01 versus each). Clinical response remission 6 75.9% (60/79) 68.4% (54/79), respectively. At 6, 72.6% (77/106) reported as 'good compliance' 54.7% (58/106) 'very easy' administration, using self-administered questionnaire.Conclusions: appeared be safe, efficacious, well-accepted cohort UC. Trial registration: JapicCTI-183858.