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

Abstract

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