Naganuma M, et al. – Researchers carried out this study to confirm mucosal healing and other therapeutic effects of twice–daily budesonide 2–mg foam in patients with mild–to–moderate ulcerative colitis including left–sided colitis and pancolitis. For the first time, they confirmed complete mucosal healing with twice–daily budesonide 2–mg foam in mild–to–moderate ulcerative colitis with distal active inflammation. Also, the outcomes revealed that complete mucosal healing of distal lesions by budesonide foam promoted clinical remission of ulcerative colitis.

• The researchers performed a multicenter, randomized, placebo-controlled, double-blind trial.
• They randomized 126 patients with mild-to-moderate ulcerative colitis with active inflammation in the distal colon to 2 groups receiving twice-daily budesonide 2 mg/25 ml foam or placebo foam.
• The percentage of complete mucosal healing of distal lesions (endoscopic subscore of 0) at week 6 was the primary endpoint.
• Through week 12, some patients continued the treatment.
• They evaluated drug efficacy and safety.

• As compared with the placebo group, the percentages of both complete mucosal healing of distal lesions and clinical remission were significantly improved in the budesonide group (p = 0.0003 and p = 0.0035).
• Regardless of disease type, subgroup analysis demonstrated similar efficacy of budesonide foam for complete mucosal healing of distal lesions and clinical remission.
• In patients achieving complete mucosal healing of distal lesions, the clinical remission percentage tended to be higher than in other patients.
• The researchers found no safety concerns with budesonide foam.