Baseline Oral 5-ASA Use and Efficacy and Safety of Budesonide Foam in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis: Analysis of 2 Phase 3 Studies.

A significant treatment effect for achieving an MMDAI endoscopy subscale score of 0 or 1 was observed in patients receiving budesonide foam versus placebo without baseline use of oral 5-ASAs (55.8% versus 31.2%; P = 0.0004); however, while treatment with budesonide foam was favored compared with placebo, the treatment difference for the subgroup of patients with baseline oral 5-ASA use did not reach statistical significance (55.8% versus 46.8%; P = 0.08).

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